[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: (a) diagnosis of schizophrenia or schizoaffectivedisorder verified by case notereview, using a checklist for DSM–IV(American Psychiatric Association,1994) criteria;(b) substance misuse and learning disabilitynot identified as the primary problem;(c) age 18–55 years;(d) persistent and clinically significant positivesymptoms, i.e. having either itemP3 (hallucinatory behaviour) or itemP1 (delusions) from the positive subscaleof the Positive and NegativeSyndrome Scales (PANSS; Kay et al,1987) scored 4 (moderate) or above,with the symptom having been presentat this level for at least 50% of thelast 2 months;(e) at least 1 month of stabilisation if thepatient had experienced a symptomexacerbation in the last 6 months (i.e.at least 1 month since discharge afteran acute admission; no change inpsychotropic medication prescribed inthe last 4 weeks);(f) informed consent from the patient.
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: The study was funded by the National HealthService Executive NorthWest Research and DevelopmentFunding and from Pennine Care NHS TrustResearch & Developmentmonies.
Country: UK
Setting:
Comments:
Authors name: Christine BARROWCLOUGH
Institution: School of Psychological Sciences,University of Manchester,UK;
Email: christine.barrowclough@manchester.ac.uk
Address: School of Psychological Sciences,RutherfordHouse,Manchester Science Park,Lloyd Street North,Manchester M15 6SZ,UK
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Det er for den samlede population, det angives at der ikke er forskel.
Louise Klokker Madsen Of the total study sample, 82 (72.6%) weremen; the mean age of the participants was38.83 years (s.d.¼8.6); the mean illnessduration was 13.67 years (s.d.¼7.99); 73participants were single (64.6%), 19(16.8%) married or cohabiting and 21(18.6%) separated or divorced; 48(42.5%) lived alone, 24 (21.2%) lived witha relative or caregiver, 33 (29.2%) lived ina supported hostel or flat and 7 (6.2%)lived in unsupported hostel or other accommodation.The majority of participants(101, 89.1%) were diagnosed with schizophreniaand 12 (10.9%) had a diagnosisof schizoaffective disorder.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Det angives at interventionen varer 6 mdr, defor er pågørelsen ved 6 mdr afslutning af interventionen, mens 12 mdr FU er 6 mdr efter interventionen. Symptomer: PANNSSocialfunktion: SFSDe angiver i teksten indlæggelsesdage, men kun median og range, kan det bruges til noget?
Louise Klokker Madsen Relapse, dichotomous data:: At the end of the 12-month followupperiod, 18 members of the CBT grouphad had at least one relapse (32.7%) comparedwith 15 (27.3%) in the treatmentas-usual group
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: (a) valid diagnosis of schizophrenia based onmeeting DSMIV criteria (b) age between 18–60
Excluded criteria: (c) persons with mental retardation,organic brain syndrome, or a primary diagnosis of alcoholism or drug abuse wereexcluded.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: ?
Country: USA
Setting:
Comments:
Authors name: William Bradshaw
Institution: School of Social Work, University of Minnesota, Minneapolis
Email: bbradshaw@che1.che.umn.edu
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Generelt for hele populationen
Intervention characteristics:
Jesper ØStrup Rasmussen community treatment vs community treatmens + CBT
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Skalaer:Symptomatology was measured by the Global Pathology Index of the Hopkins PsychiatricRating Scale (Derogatis, 1974). The GPI is an 8 point behaviorally anchored scalethat describes severity of symptoms. Psychosocial functioning was measured by theRole Functioning Scale (RFS) (Goodman, et al., 1993). The RFS is made up of foursubscales: work, social, family and independent living subscales. Each subscale is a 7point behaviorally anchored scale. Rehospitalization was measured by the total numberof psychiatric hospitalizations clients had during the treatment period.
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: All willing patients who met the DSM-IV3diagnostic criteria for a schizophrenia orschizoaffective disorder were screened andevaluated by a doctoral-level clinician and experienceddiagnostician.
Excluded criteria: Patients with medicationnoncompliance as a current and clinicallysignificant problem or with a history of alcohol/substance abuse or dependence in the precedingyear were excluded. Those with ahistory of moderate to severe neurological impairmentor mental retardation as documentedin medical records were excluded, as well asthose who were significantly psychiatricallyunstable as defined by scores of 5 (maximumscore per item = 7) or more in any of the followingPositive and Negative SyndromeScale34 domains: conceptual disorganization,hallucinatory behavior, or unusual thoughtcontent.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: This article is based on research supported by agrant to the author from the Long Island JewishMedical Center Faculty Research Competitive PoolGrant Program.
Country: USA
Setting:
Comments:
Authors name: Linda Daniels
Institution: Long Island Jewish Medical center
Email: -
Address:
Identification:
Participants:
Jesper ØStrup Rasmussen Jeg ser et vis problem i eksklusionskriterierne i fht vores P.
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen For hele populationen generelt.
Louise Klokker Madsen 40 patients (27 men and 13women, mean age = 33.7 years, age range19–61) were included in the study. Twentypatients were receiving outpatient treatmentfrom the Adult Continuing Day TreatmentProgram, and 20 were enrolled in the AmbulatoryOutpatient Clinic. The total sample(N = 40) included the following diagnosticcategories: paranoid schizophrenia (n = 24),schizoaffective (n = 12), undifferentiatedschizophrenia (n = 3), and catatonic schizophrenia(n = 1). Mean age of illness onset was21.56 years (SD = 9.25, range 12–36 years),and total number of hospitalizations was 3.26(SD = 2.56, range 0–10).
Intervention characteristics:
Jesper ØStrup Rasmussen Interventionen er ikke ren CBT, men en blanding (har forhørt mig hos Lone, interventionen er ok):The present study assesses the efficacy ofInteractive-Behavioral Training (IBT) anapproach to social skills training with a combined focus on cognitive-behavioral techniques (such as instruction, modeling, and behavioral rehearsal) and group process strategies. The IBT format directly facilitates therapeutic group process and uses established cognitive-behavioral strategies. The blending of cognitive-behavioral and group process interventions is therefore postulated to increase motivation for learning, improve social skills acquisition, and enhance overall social competence. It appears, then, that IBT should improve the effectiveness of current social skills training models, inasmuch as therapeutic group process itself reduces negative symptoms by increasing motivation for social learning. Through the use of cognitive-behavioral and interpersonal group process strategies, group members may learn to participate fully and to act as vehicles for social learning by serving as clarifiers of affect, reality testers, and interpersonal behavioral and problem-solving models. Thus, the combination of cognitivebehavioral and interpersonal group process strategies may offer the most comprehensive and dynamic social skills treatment package. The application of cognitive-behavioral social skills techniques with group process strategies may then fill the current gap in outcome research between social skills and social competence.
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen Six of the 40 participants did not complete the study and were therefore excluded from thefollowing analysis (not stated how many in each group)
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: patients with psychosisand a diagnosis of schizophrenia, schizoaffectivedisorder or delusional disorder,aged 16–65 years who are known to thepsychiatric services as suffering from positivesymptoms of persistent and distressinghallucinations or delusions, or both, andwho have been stabilised on anti-psychoticmedication for at least a 6-month periodunder the care of a consultant psychiatrist.
Excluded criteria: Exclusion criteria were: primary diagnosisof alcoholism or drug misuse, evidence oforganic brain disease and history of violence
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: The preparation of this article wasmade possible bya grant to R.C.D., R.V.M. and D.A.R. by the ChiefScientist Office, Scottish Home and Health Department,Edinburgh, whose financial support is gratefullyacknowledged
Country: UK
Setting:
Comments:
Authors name: ROBERT C. DURHAM,
Institution: Department of Psychiatry,Ninewells Hospital & Medical School
Email: r.c.durham@dundee.ac.uk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen længste FU er efter 3 mdr, så kan jo faktísk ikke indgår, grundet vores cutoff på 4-6 mdr. Social funktion: GAS (higher score indicates a better outcome)
Louise Klokker Madsen PSYRATS delusions
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: experiencing a first treated episode of apsychotic disorder that fulfilled the DSM-IV criteria fora diagnosis of schizophrenia, schizophreniform disorder,delusional disorder, or psychotic disorder not otherwisespecified; being registered with EPPIC for 12 to 26 weeks;and continuing to experience moderate to severe positivesymptoms, defined as a score ≥4 on at least one of thehallucinations, unusual thought content, and conceptualdisorganisation items of the expanded version of the briefpsychiatric rating scale (BPRS; [13]), with a score of notless than 3 on these items for a period of 14 consecutivedays or more during the preceding 12 weeks. All participantshad been treated with at least one atypical antipsychotic(usually risperidone, olanzapine or quetiapine) at doses upto 500 mg chlorpromazine equivalence (if tolerated), withdemonstrated medication compliance for at least the past 4weeks.
Excluded criteria: Exclusion criteria were an organic mental disorder,pregnancy or lactation, requiring antidepressant medication,a mood stabiliser or ECT, and a history of drug-inducedgranulocytopenia.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: The research was supported by the Victorian Government’sHealth Promotion Foundation and NOVARTIS. NOVARTISpersonnel were not involved in the study design, dataanalysis, or publication. H. P. Yuen performed the statisticalanalysis and the protocol can be obtained from J. Edwards.
Country: Australia
Setting:
Comments:
Authors name: J. Edwards
Institution: OrygenYouth Health Centre for Youth Mental Health, University of Melbourne
Email: j.edwards@unimelb.edu.au
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Alle er førsteepisode psykoser.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen FU kan ikke bruges da den ikke er over 4-6 mdr. Skalaer:Psykotiske symp: BPRS-PNEgative symptomer: SANSSocialfunktion: SOFASQoL: QLS
Louise Klokker Madsen Mental state was determined with theexpanded version of the BPRS [13]. The BPRS psychoticsymptoms subscale (BPRS-P) was used to assess positivesymptoms, while the scale for the assessment of negativesymptoms (SANS; [15]) and the short form of the Beckdepression inventory (BDI; [16]) assessed levels of negativesymptoms and depression, respectively. The clinical globalimpression (CGI; [17]) was used to measure the severityof psychotic disorder, as well as the degree of improvementsince baseline. Psychosocial functioning was assessed usingthe social and occupational functioning assessment scale(SOFAS; [18]) and quality of life survey (QLS; [19]).
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: a preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder,delusional disorder, or mood disorder with psychotic features; and, in the opinion of theircase manager, one or more recovery needs that could potentially be addressed by acomponent (see later) of the local version of CBTp, ‘Recovery Therapy’. Each clientaccepted from May 2000 to July 2003 who met the criteria was invited to participate.
Excluded criteria: Exclusions were patients with a diagnosis of any DSM-IV non-psychotic disorder,brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinationsor delusions, or patients with a co-morbid intellectual disability or withoutconversational English. Those with co-morbid substance use disorders were notexcluded.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: The study was funded by the William Buckland Foundation, with additional assistance from LaTrobe University and the Department of Human Services, Victoria.
Country: Australia
Setting:
Comments:
Authors name: John Farhall
Institution: 1School of Psychological Science, La Trobe University, Melbourne, Australia 2North Western Mental Health, Melbourne, Australia
Email: j.farhall@latrobe.edu.au
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Det angives at outcomes måles:1) ved vaseline2)ved afslutning af intervention (gn. 9-12 mdr efter baseline)3)igen 9 mdr efter interventionen. således kan FU godt bruges som længste FU.
Louise Klokker Madsen PANSS negative + positive, Life Skills Profile
Dichotomous outcomes:
Adverse outcomes:
Study design:
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: (a) a current clinical diagnosis of non-affective psychosis (ICD–10category F2 and DSM–IV);(b) age 18–65 years;(c) a second or subsequent psychotic episode starting not morethan 3 months before they agreed to enter the trial;(d) a rating of at least 4 (moderate severity) for at least onepositive symptom on the Positive and Negative SyndromeScale (PANSS).17
Excluded criteria: (a) a primary diagnosis of alcohol or substance dependency,organic syndrome or intellectual disability;(b) a command of spoken English inadequate for engaging inpsychological therapy;(c) unstable residential arrangements such that the likelihood ofbeing available for the duration of the trial was low.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: The study was supported by a Wellcome Trust Programme Grant (062452)
Country: UK
Setting:
Comments:
Authors name: Philippa A. Garety
Institution: Department of Psychology, PO77, Institute of Psychiatry, De Crespigny Park, London, SE5 8AF, UK.
Email: p.garety@iop.kcl.ac.uk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen End of treatment: 12 mdrFU: 24 mdrIndlæggelsesdage: mellem 0-12 mdrSocialfunktion: SOFASDer er desuden Qol, men kun fo r24 mdr.Symptomer:PANSS
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Schizophrenia or schizoaffective disorder. 42-74 years old.
Excluded criteria: disabling medical problems that would interfere with testing, absence of medical records to inform diagnosis, and diagnosis og dependence on substances other than nicotine or caffeine within the past 6 months.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: Office of Research and Development, Medical Research Service, Department fo Veterans. National Alliance for Reasearch on Schisophrenia and Depression
Country: USA
Setting:
Comments:
Authors name: Eric Granholm
Institution: San Diego State University
Email: egranholm@ucsd.edu
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Jeg ved ikke hvordan dette format sættes ind,Effekt på:- poitive symptomer: F=2,38 df=1, 71 P=0,13 η^2=0,03- negative symptomer: F=0,43 df=1, 71 P=0,52 η^2=0,01
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Eligibility criteria included the following: diagnosis ofDSM-IV schizophrenia or schizoaffective disorder; prominentnegative symptoms (at least moderate severity on 2 Scale forthe Assessment of Negative Symptoms29 global subscales, ormarked severity on 1 subscale); aged 18 to 65 years; proficientin English; and able to give informed consent.
Excluded criteria: Exclusion criteriaincluded the following: neurologic disease or damage thatwould compromise cognitive functioning; and physical handicapsthat would interfere with assessment procedures or therapyattendance.
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: Financial Disclosure: Drs Grant, Stolar, and Beck havereceived royalties from Guilford Press.Funding/Support: This work was supported by a DistinguishedInvestigator Award from the National Alliancefor Research on Schizophrenia and Depression (DrBeck) and by grants from the Heinz Foundation and theBarbara and Henry Jordan Foundation.Role of the Sponsors: The sponsors had no role in designand conduct of the study; collection, management,analysis, and interpretation of the data; or preparation,review, or approval of the manuscript.
Country: USA
Setting:
Comments:
Authors name: Paul M. Grant
Institution: Perelman School of Medicine, University of Pennsylvania, Philadelphia
Email: pgrant@mail.med.upenn.edu
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen SANS negative symptoms, at 18 months:CT: adjusted mean [SE], 1.66 [0.31] ST: 2.81 [0.34]positive symptoms, at 18 months:CT:: adjusted mean [SE], 9.4 [3.3]ST: 18.2 [3.8]GAS, at 18 monthsCT:adjusted mean [SE], 58.3 [3.30]ST: 47.9 [3.60]
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Entryrequired that patients fulfilled DSM-IV (AmericanPsychiatric Association, 1994) criteria forschizophrenia or a related disorder confirmedby the Structured Clinical Interview for DSMIV(First et al. 1994), were aged between 18 and65, were receiving antipsychotic medication,and were considered relapse prone. Patientswere considered relapse prone if they had oneor more of the following characteristics : (1) ahistory of relapse in the last 2 years; (2) theirkeyworker viewed them as living in a stressfulenvironment (e.g. a home environment characterizedby high levels of expressed emotion); (3)living alone or socially isolated ; (4) nonadherencewith antipsychotic medication (wherethis was viewed as problematic by the participant’skeyworker and/or prescribing psychiatrist); and (5) being on a neuroleptic dosagereduction programme.
Excluded criteria: Patients were excludedif they were a non-English speaker, had organicbrain disorder, presence of significant learningdisability, severe positive psychotic symptoms(rating of o5 on the positive scale of the Positiveand Negative Syndrome Scale (PANSS)(Kay et al. 1987), a primary drug or alcoholdependence disorder (based on the opinion ofthe key worker), or being in receipt of a concurrentpsychotherapy outside the study.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: The research was supported by a grant (K/RED/18/13) to Andrew Gumley and Kevin Power from theChief Scientist Office, Scottish Executive.
Country: UK (Scotland)
Setting:
Comments:
Authors name: A. Gumley
Institution: Department of Psychological Medicine, University of Glasgow
Email: -
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Louise Klokker Madsen Illness duration in months
Intervention characteristics:
Jesper ØStrup Rasmussen De kommer i gennemsnit lige præcis op på 10 sessiond, hvorfor jeg ikke har ekskluderet den.
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PANSS positive + negativeSFS, Withdrawal
Jesper ØStrup Rasmussen Skala: PANSSDesuden angives socialfunktion med SFS, skal lige finde ud af hviklet af domænerne der skal bruges. At 12 months the CBT groupshowed greater improvement in positive symptoms(-1.10, P=0.028, 95%CI-2.08,-0.12)negative symptoms (-1.89, P=0.016, 95% CI-3.39, -0.35),
Dichotomous outcomes:
Jesper ØStrup Rasmussen Relapse:A total of 13(18.1%) participants in CBT relapsed comparedto 25 (34.7%) in TAU (HR=0.47, P=0.028,95% CI 0.24, 0.92, NNT=6).
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
CBT
TAU
Included criteria: i) suffering from schizophrenia, schizoaffective disorder, or persistent delusionaldisorder according to ICD-10 (WHO, 1992); ii) residual auditory hallucinations and delusionsexperienced in the last 6 months, which had caused distress despite the use of neuroleptics;iii) in the age group 18–60 years; and iv) ability to give informed consent to participate in thestudy.
Excluded criteria: i) no perceived distress produced by delusions or hearingvoices; and ii) no substance use diagnosis.
Intervention Characteristics
CBT
TAU
Continuous:
Dichotomous:
Sponsorship source: The study was supported bythe Department of Research and Development at St Olavs University Hospital, Trondheim,Norway.
Country: Norway
Setting:
Comments:
Authors name: Bodil Kråkvik
Institution: St. Olavs University Hospital, Trondheim, Norway
Email: bodil.krakvik@stolav.no
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen BPRSSANSGAF functionPSYRATS emotional
Jesper ØStrup Rasmussen Skalaer:Negative symp.: SANS (low=better)Jeg tænker ikke at PSYRATS kan bruges, da den er opdelt i subskalaer. ved 12 mdr. FU er der kun angivet en effekt, for SANS er den:12-month N=27 M=7.59 sd=3.63 df=(1,26) F=0.03
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: at least onecurrent positive psychotic symptom (such asdelusions or hallucinations) that was distressing, unremitting (at least the past sixmonths) and medication resistant, that ishad not responded to a previous trial of atleast six months of appropriate neurolepticmedication. Clients prescribed clozapineneeded to have been stable on this for atleast one year (to allow time for all benefitto occur).
Excluded criteria: People who had drug, alcohol ororganic problems as primary features wereexcluded.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This research was supported by aResearchand Development grant from the Department of Health.We are grateful for a charitable donation from Janssen Pharmaceutica.
Country: UK
Setting:
Comments:
Authors name: ELIZABETH KUIPERS
Institution: Department of Clinical Psychology,Institute of Psychiatry, London
Email: -
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen BPRSOBS: selective outcome reporting (Change on all othersymptom and functioning measures was notsignificantly different between conditions atthis stage of the trial.)
Dichotomous outcomes:
Jesper ØStrup Rasmussen (A five-point change on theBPRS is similar to the criterion of a 20%improvement taken to be an index of clinicalresponse on the BPRS by Breier et a!(1994)). In these terms, 6/28 (21%) achieveda large clinical improvement, and a further8/28 (29%) of the treatment group achieveda reliable clinical improvement. One personof the 28 (3%) in the treatment groupshowed a reliable worsening of symptomson the BPRS. In the control group, 1/32(3%) showed a large clinical improvementand 9/32 (28%) of cases achieved reliableclinical improvements. Three of the 32 (9%)of the control group showed a clinicallysignificant worsening of symptoms over thenine months.
Adverse outcomes:
Study design:
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: I) a diagnosis of schizophrenia, schizo-affectivedisorder, or paranoid psychosis confirmedby the Structured Clinical Interview for DSM-Ill-R(SCID) (Williams el al., 1992)-SCID IV was notavailable at the beginning of the study; 2) the abilityto speak, read, and write French; and 3) consentfrom the subject (or trustee, if applicable) to participatein the study
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: ?
Country: Canada
Setting:
Comments:
Authors name: Claude Leclerc
Institution: University of Quebec
Email:
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Alder = hele populationen.
Louise Klokker Madsen origin(89.2%). Their mean age was 40.6 years ( S B10.7) at the start of the study, and 24.2 years (SB6.8) at first hospitalization; 87.5% were single, and84.2% unemployed at the start of the study. Theyhad completed a mean of 10.2 years of school(SB3.0). At Time I , 5.1% lived in an apartment,and 75.9% were psychiatric inpatients.The mean number of years of lifetime hospitalizationwas 17.83 (SD=ll.74) for the experimentalgroup, 1 1.80 (SB8.65) for the control group, and1 1.88 (SD=7.66) for the intent-to-treat group. Themean number of hospitalizations was 4.19 (SO=3.79) for the experimental group, 3.77 (SD=3.95)for the control group, and 4.47 (SB2.50) for theintent-to-treat group. These differences were notsignificant according to the Students t-test.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen TIme 1: lige efter interventionenTime 2: 6 mdr FU
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Individualswere eligible if aged between 18 and 35, fluent (verballyas well as reading and writing skills) in one of the officiallanguages (English and French), currently presenting with persistentor fluctuating psychotic symptoms (defined as delusionsor hallucinations appearing occasionally, such as in periods ofstress), having consulted for the first time a mental healthprofessional for psychotic symptoms in the past 2 years, andbeing followed by a psychiatrist (and therefore receiving antipsychoticmedication). Individuals were only recruited once theyhad been discharged from the hospital and considered “stabilized”by their psychiatrist. Nonaffective psychosis was preferredbut individuals with unclear diagnoses at the time of thereferral were also accepted.
Excluded criteria: Exclusion criteria included sufferingfrom an organic disorder, having already received one of theinterventions, and not being able to give informed consent
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: Supported by grant 43975 from the Canadian Institutes of Health Research(CIHR; to T.L., C.L., T.W., and C.J.W.).The corresponding author also benefited from a salary award from CIHR toconduct this study.
Country: Canada
Setting:
Comments:
Authors name: Tania Lecomte
Institution: Department of Psychology, Universite´ de Montre´al
Email: tania.lecomte@umontreal.ca
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Da interventionen varer 3 mdr, tager jeg T1 som end of treatment.
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Inclusion criteria for subjects to enterthe trial were: (a) either first or secondadmission (within 2 years of a first admission)to in-patient or day patient unit fortreatment of psychosis; (b) DSM–IV criteriafor schizophrenia, schizophreniform disorder,schizoaffective disorder or delusionaldisorder (American Psychiatric Association,1994); (c) positive psychotic symptoms for4 weeks or more; (d) score of 4 or more(moderate or severe) on the PANSS (Kayet al, 1989) target item either for delusions(P1) or hallucinations (P3); (e) neither substancemisuse nor organic disorder judgedto be the major cause of psychotic symptoms.Patients legally detained in hospitalwere eligible.
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Sponsorship source: The trial wasfunded as follows: UK Medical Research Council(41%); Northwest England NHSE Office (27%);Trent NHSE Office (7%); the following healthauthorities: Manchester (8%); Salford and Trafford(2%); Liverpool (3%); Sefton (3%); St Helens andKnowsley (3%);North Nottinghamshire (6%).
Country: UK
Setting:
Comments:
Authors name: S. LEWIS
Institution: School of Psychiatry and Behavioural Sciences,University of Manchester
Email:
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Jeg har medtaget de skizofreniforme.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Five post-baseline assessmentvisits were scheduled: at 14, 21, 28 and35 days and the final acute-phaseassessment between 42 and 70 days.Behandlingen var 5 uger, med efterføjgende booster, så jeg har taget 35 dage som afslutning af intervention.
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Patients had tohave a diagnosis of schizophrenia, schizoaffective disorder, delusionaldisorder, or brief psychotic disorder. Furthermore, they hadto be at least 16 years old and have sufficient German or Englishlanguage skills to communicate with the therapist. For ethicalreasons, acutely suicidal patients were excluded and referred topsychiatric specialized departments. One patient with acute heroinaddiction was required to attend detoxification treatment beforebeginning therapy. No further criteria were applied.
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: ?
Country: Germany
Setting:
Comments:
Authors name: Tania M. Lincoln
Institution: Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg, Marburg, Germany.
Email: tania.lincoln@uni-hamburg.de
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Louise Klokker Madsen Sygdomsvarighed= Years of psychosis
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PANSS-positive, PANSS-negative, RFS-Social II, PDI-distress
Jesper ØStrup Rasmussen Skalaer: symptomer: PANSSSocialfuntion RFS ( Self-report scale whereby the total of four sub-scales measuresglobal role functioning. Higher scores indicate better functioning.) Jeg har taget immediate social network. Distress: PDIKan ikke finde 1 year FU, for hver enkelt gruppe, kun samlet:Positive symp: 0.65 [0.33, 0.98]Negative Symp: 0.28 [0.00, 0.55]
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria:
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This project was funded by a NARSAD
Country: USA
Setting:
Comments:
Authors name: Narsimha R. Pinninti
Institution: Department of Psychiatry, University of Medicine and Dentistry, New Jersey, School of Osteopathic Medicine, 2250 Chapel Ave. West, Cherry Hill, NJ 08034
Email: narsimha.pinninti@sbcs.us
Address:
Identification:
Participants:
Louise Klokker Madsen fandt ikke supplementary file
Study design:
Baseline characteristics:
Louise Klokker Madsen For the 25 outpatientswho completed pre- andposttest evaluations, 14 (56%) werewomen and 11 (44%) were men.Twenty (80%) were European Americans,one (4%) was African American,one (4%) was Hispanic American,and three (12%) persons describedthemselves as of “other” raceor ethnicity. Thirteen (52%) had nevermarried, and 22 (88%) were unemployed.The mean±SD age was 40±11years. The mean number of years ofhospitalization was 3±3. Twenty-two(88%) were diagnosed as havingschizoaffective disorder, and three(12%) were diagnosed as having paranoidschizophrenia.
Jesper ØStrup Rasmussen Kun angivet for hele populationen.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PSYRATS Auditory hallucinations (possible scores range from 0 to 44, with higher scores indicating greater symptomatolog)
Jesper ØStrup Rasmussen FU: 24 ugerPSYRAT (sættes ind i skema i RevMan)Auditory hallucinationsSecond-generation antipsychotic 14.45 (12.82)Second-generation antipsychotic + CBT 12.71 (13.59) DelusionsSecond-generation antipsychotic 13.64 (4.84)Second-generation antipsychotic + CBT 9.57 (6.96)
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Participants were eligible if they were:1. Between ages 18 and 65 with a diagnosis of schizophrenia, schizoaffectivedisorder or delusional disorders using ICD-10 ResearchCriteria.2. From the following groups:• Black British, Black Caribbean or African Caribbean (all threeterms usually refer to people of Caribbean origin with Caribbeanorigin parents and heritage, even if they are born in the UKthemselves).• South Asian Muslim (Pakistani and Bangladeshi—refer to peopleof Muslim religion who either have their origins in South Asia ortheir parents and heritage are).3. Willing to participate in the interview and/or be tape recorded.4. Had mental capacity to consent and participate.5. Able to speak English orwerewilling to participate with interpreters.
Excluded criteria: 1. Severe illnesswhich would affect ability to participate in assessmentsor therapy e.g. very thought disordered or distressed by symptoms.2. Lacked mental capacity or denied consent.3. The treating clinical team thought was inappropriate. For e.g. if theywere due to receive CBT through their services as standard treatmentand being in the trial could mean they may be randomisedto TAU arm.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This trial was part funded by the DRE, Clinical Trailblazers programme and SouthernHealth NHS Foundation Trust and forms part of author PPs doctoral thesis.
Country: UK
Setting:
Comments:
Authors name: Shanaya Rathod
Institution: Southern Health NHS Foundation Trust, UK
Email: shanayarathod@nhs.net
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Skalaer:Negative symptomer: BRAINHallucinationer og vrangforestillinger: PSYRATS (skal lige finde ud af hvordan de kan tages med under et)6 mdr FU.
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: Participants wereincluded if they met the following criteria: a DSMIV(American Psychiatric Association, 1994) diagnosisof schizophrenia or schizoaffective disorder basedon the Structured Clinical Interview for DSM-IV AxisI Disorders—Version 1 (First et al., 1995); the presenceof persistent positive and negative psychoticsymptoms in the past 6 months as determined by theSCID-I interview; stable treatment with antipsychoticmedications; age 18–65.
Excluded criteria: Patients were excluded fromparticipation on the basis of suspected organic brainpathology; concurrent substance abuse or dependence;and past treatment with either behavioral or cognitive–behavioral therapy in either individual or familyformat.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This study was funded by the Ontario MentalHealth Foundation (OMHF).
Country: Canada
Setting:
Comments:
Authors name: Neil A. Rector
Institution: Mood and Anxiety Program, Centre for Addiction and Mental Health, Clarke Division, University of Toronto
Email: neil_rector@camh.net
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Skala: PANSSFU: 6 mdr
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: age 16-60, diagnosis of schizophrenia (ICD-10 + DSM-IV), symptoms causing distress and/or dysfunction for at least 6 months despite medication.
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: Grant 039243 from the Welcome Trust, London, England. Further financial support by Hounslow and Spelthorne Community and Mental Health National Health Sevice Trust.
Country: UK
Setting:
Comments:
Authors name: Tom Sensky
Institution: Division of Neurosciences and Psychological Medicina, Imperial College School of Medicins, London, England
Email:
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Skala: SANS
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: diagnosis of schizophrenia or related conditionbased on DSM-IV criteria, aged between 18 and 65 years and havingexperienced command hallucinations within the previous 6months that caused distress or dysfunction despite treatment withantipsychotic medication at therapeutic doses
Excluded criteria: any neurological disorder that may affect cognitive function;insufficient conversational English for meaningful participation;current abuse of alcohol or drugs requiring specific clinical intervention;having a premorbid IQ of less than 70, and inability to giveinformed consent
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This research was funded by grants from the National Healthand Medical Research Council of Australia (Grant 251730) and theRebecca L Cooper Medical Research Foundation. Therapist trainingin mindfulness was funded by grants from Novartis PharmaceuticalsAustralia Pty Ltd and Eli Lilly Australia Pty Ltd. These fundingsources had no involvement the collection, analysis and interpretationof data; in the writing of the report; and in the decision tosubmit the paper for publication.
Country: Australia
Setting:
Comments:
Authors name: Frances Shawyer
Institution: School of Psychological Science, La Trobe University, Victoria 3086, Australia
Email: fshawyer@gmail.com
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PANSS positivePANSS negativeDistress (PSYRATS)QOL (feelings)GAF
Jesper ØStrup Rasmussen FU: 6 mdrMht. populationen skriver de et intervel, jeg har bare taget midt imellem, hhv 18 og 19Skalaer: symptomer: PANSSDistress: PSYRATSQoL: QLS (jeg har taget: The General Activities subscale measures degree of satisfaction with general activities of life such as work, social relationships and ability tofunction.))Socialfunktion: GAF
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: aged between 18 and 65years, were resident within the catchment area,had received a clinical diagnosis of schizophrenia,schizophreniform or schizo-affectivedisorder, appeared to be suffering an acutepsychotic episode, were not already receivingpsychological treatment, and showed no evidenceof organic mental disorder.
Excluded criteria: Those who acceptedwere then excluded if, during a baselineassessment, they were found not to be sufferingan acute psychotic episode (N=13), their diagnosescould not be confirmed according toDSM-IV (American Psychiatric Association,1994) criteria (N=7), they had been dependenton alcohol or illicit drugs according to DSM-IVcriteria during the past year (N=12), or theirIQs, assessed by the Quick Test (Ammons &Ammons, 1962), were below 80 (N=19).
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This trial was supported by grant RC012 from theWales Office of R & D for Health & Social Care andby Conwy & Denbighshire, North-West Wales, andNorth-East Wales NHS Trust
Country: Australia
Setting:
Comments:
Authors name: Mike Startup
Institution: School of Behavioural Sciences, University of Newcastle
Email: Mike.Startup@newcastle.edu.au
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen SAPS - psychoticSANS totalSocial Functioning Scale
Jesper ØStrup Rasmussen Da de skriver at interventionen tager 25 uger, tager jeg 6 month som end of treatment og 12 month som 6 mdr FU.
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: a diagnosisof schizophrenia, schizoaffective psychosisor delusional disorder using DSM-111-R(American Psychiatric Association, 1987)criteria; no evidence of organic brain disease;substance abuse was not identified asthe primary problem; aged between 18and 65 years; suffering persistent hallucinationsand/or delusions for a minimum of sixmonths, and at least one month of stabilisationif they had suffered an exacerbationduring this period; were on stable medication;were not receiving psychological orfamily intervention; their responsible medicalofficer had given permission for themto enter the study; and they had giveninformed consent to pamcipate.
Excluded criteria:
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: The Wellcome Trust
Country: UK
Setting:
Comments:
Authors name: NICHOLAS TARRIER
Institution: University of Manchester
Email: nlarrer@frl.wfh.man.
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Louise Klokker Madsen 52 (74%) were male; they had a meanage of 39.4 (s.d.=10.9) years; 64 (93%) had a diagnosis of schizophrenia,three (4%) a schizoaffective disorder andtwo (3%) a delusional disorder; they had amean duration of illness of 14.2 (s.d.=9.9)years
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Positive symptomer: BPRS (high scores indicate more severe symptoms)negative symptomer: SANS (High scores indicate a worse outcome.)
Dichotomous outcomes:
Jesper ØStrup Rasmussen Definition af relapse: rehospitalisationfor a clinical deteriorationthat resulted in functional impairment andhospitalisation for at least five days,although not an ideal measure, was chosenas a practical indicator of relapse
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
CBT
TAU
Included criteria: (a) aged between18 and 65; (b) had a DSM IV diagnosis of schizophrenia,schizophreniformdisorder, schizoaffective disorder, delusional disorderor psychotic disorder not otherwise specified; (c) identified as havingprevious suicide attempts or experiencing current suicidal ideation;(d) under the care of an appropriate clinical team and currently incontact with mental health services; (e) receiving appropriate antipsychoticmedication; and, (f) not currently receiving CBT or otherempirically validated psychological treatments.
Excluded criteria: (a) currently suffered serious suicidal intent andwere currently considered a danger to themselves; (b) had a primarydiagnosis of bipolar depression or substance induced psychosis; and,(c) suffered from an organic brain disease.
Intervention Characteristics
CBT
TAU
Continuous:
Dichotomous:
Sponsorship source: This report/article presents independent research commissioned by the NationalInstitute for Health Research (NIHR) UK under its Programme Grants for Applied Researchscheme (RP-PG-0606-1086).
Country: UK
Setting:
Comments:
Authors name: Nicholas Tarrier
Institution: Department of Psychology, Institute of Psychiatry, London, UK
Email:
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Angives kun for hele populationen.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PANSS totalPANSS negativePSYRATS hallucinationsGAF total
Jesper ØStrup Rasmussen De får behandling i 3 mdr, og der er FU ved 4 mdr, derfor tager jeg denne som end of treatment. 6 mdr er kun 2 mdr herefter og kan derfor ikke indgå. Skalaer:Symptyomer: PANSS (low=better)Distress: PSYRATS hallucinations
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: ICD–10 diagnosis ofschizophrenia or related disorder withcommand hallucinations for at least 6months (World Health Organization,1992). Participants were required to havea recent history of compliance with, andappeasement of, voices with ‘severe’commands, including harm to self, othersor major social transgressions.
Excluded criteria: Patientswere excluded if they had a primaryorganic or addictive disorder.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: The research undertaken for this study wassupported by a grant from the Department ofHealth to P.T., M.B. and A.M.
Country: UK
Setting:
Comments:
Authors name: PETER TROWER
Institution: School of Psychology,University of Birmingham, Edgbaston,Birmingham B15 2TT,UK
Email: M.J.Birchwood.20@Bham.ac.uk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen PSYRATS distress
Jesper ØStrup Rasmussen end of treatment ved 6 month, FU ved 12 month. Skalaer: Distress: Psyrats, højere score, dårligere outcome. Symptomerve er rapporteret som den med F:Although change in psychotic symptomswas not predicted, a significant dropoccurred in PANSS positive symptomsamounting to 3.7 points in the CTCHgroup, from a baseline of 21.8, and a smallincrease occurred in the control group(F=12.6, P<0.001). Similarly, therewas a small but consistent reduction innegative symptoms (F=4.8,P=0.001) in the CTCHgroup These effects weremaintained at 12 months for positive symptoms(F= 14.2, P=0.001), negativesymptoms (F=12.3, P=0.002)
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
TAU
CBT
Included criteria: (a) age 18–64;(b) diagnosis of schizophrenia or schizoaffective disorder(DSM–IV–TR, 295.xx)16(c) Positive and Negative Syndrome Scale (PANSS)17 scores ofdelusions 54 OR hallucinations 54 OR suspiciousness54) AND Psychotic Symptoms Rating Scale (PSYRATS)18scores delusions-suffering 52 AND delusions-impact 52OR hallucinations-suffering 52 AND hallucinations-impact52;(d) treatment resistance defined as failure of two or more antipsychotictreatments of at least 6 weeks over the past2 years.
Excluded criteria: intellectual disabilities withIQ580; severe addiction; no competence in the Dutch language;and previous exposure to CBT.
Intervention Characteristics
TAU
CBT
Continuous:
Dichotomous:
Sponsorship source: This study was supported by grant 945-04-406 of the Netherlands Organization for HealthResearch and Development (ZonMW) and the contributions of the Universities of Groningenand Utrecht and the mental healthcare organisations Lentis, GGZ Drenthe, Mediant,Dimence, Altrecht, Parnassia and the Grote Rivieren.
Country: The Netherlands
Setting:
Comments:
Authors name: Mark van der Gaag
Institution: VU University and EMGO Institute, Department of Clinical Psychology, Amsterdam and Parnassia Psychiatric Institute, Department of Psychosis Research, The Hague
Email: m.van.der.gaag@psy.vu.nl
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Louise Klokker Madsen QoL=World Health Organization – Quality of Life, totalOther outcomes:PANSS totalPSYRATS total
Jesper ØStrup Rasmussen Til symptomer rapporteres kun totalscorer på både PANSS og PSYRATS.QoL: WHO-QOL
Dichotomous outcomes:
Jesper ØStrup Rasmussen De angiver hvor mange der har et godt funktionsniveau ud fra: the level of social functioning had to be in the 95% rangeof the normal population (assessed by the Social Functioning Scale (SFS));19 there had to be no or minimal suffering fromresidual symptoms; and there had to be no or minimal affect on daily living of residual symptoms on the PSYRATS.CBT: EoT: 33/109 LFU: 39/109TAU: EoT: 20/97 LFU 25/97
Adverse outcomes:
Fremmedsprog
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
n.i.
n.i.
n.i.
n.i.
n.i.
Quote: "The randomization was administrated by an independent office not involved in the study. In order to avoid potential group bias in the distribution of auditory hallucinations, the participants were stratified with respect to whether or not they had auditory hallucinations. The block design was arranged with different inter-block probabilities of group allocation, which were blind to the assessors."
n.i.
n.i.
n.i.
Quote: "participants were randomised using a clinical data management system"
Comment: participants were randomisedusing a clinical data management system and allocated
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
n.i.
n.i.
n.i.
n.i.
Quote: "The randomization was administrated by an independent office not involved in the study. In order to avoid potential group bias in the distribution of auditory hallucinations, the participants were stratified with respect to whether or not they had auditory hallucinations. The block design was arranged with different inter-block probabilities of group allocation, which were blind to the assessors."
n.i.
n.i.
n.i.
n.i.
Quote: "Randomisation was controlled by staff not directly linked to the trial to ensure independence and blindness to the trial allocation arms."
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
Comment: Waitlist.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
Comment: Not possible.
n.i.
n.i.
Detection bias due to knowledge of the allocated interventions by outcome assessors
n.i.
Quote: "All four professionals were trained in the use of assessment measures, but it was not possible to keep them blind to the treatment condition."
Comment: All assessments were carried out by three psychologists and one psychiatric nurse, none ofwhich was involved in the patients’ therapy. All four professionals were trained in the use ofassessment measures, but it was not possible to keep them blind to the treatment condition.
n.i.
Quote: "Participants were informed of the randomisation outcome via a letter, which also contained a note reminding them not to disclose any information about their care or treatment during assessments which would break the blind requirement. In cases where the RAs were un- blinded, protocols were followed whereby unblinding was documented and the assessment packs were scored by another RA. Masking was further maintained by ensuring that therapists and RAs were located in different offices so that therapy files and assessment data were stored separately. In addition, clinical staff were repeatedly instructed not to disclose any knowledge of therapy or group allocation to assessors."
Comment: Participants were informed of the randomisation outcome via aletter, which also contained a note reminding them not to disclose anyinformation about their care or treatment during assessments whichwould break the blind requirement. In cases where the RAs were unblinded,protocolswere followedwhereby unblindingwas documentedand the assessment packs were scored by another RA. Masking wasfurther maintained by ensuring that therapists and RAs were locatedin different offices so that therapy files and assessment datawere storedseparately.
n.i.
Attrition bias due to amount, nature or handling of incomplete outcome data
n.i.
Quote: "Of the patients allocated to the treatment group, 5 refused to continue the therapy, and 2 patients did not meet for post-treatment. No patients in the waiting list group dropped out during the waiting period. However, when the waiting list group received CBTp + TAU after waiting for 6 months, 6 patients refused to continue the therapy"
n.i.
n.i.
Quote: "attrition levels at follow up were high. However, attrition from samples that experience severe mental illnesses is often substantial because it is challenging to engage and treat such individuals. Furthermore, apart from delusions measured by the PSYRATS, there were no differential effects of drop out status across the TAU and Treatment conditions."
Reporting bias due to selective outcome reporting
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
Bias due to problems not covered elsewhere in the table
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.
n.i.