[Summary text]
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
RCT, 12 weeks intervention and 3 month FU
A total number of 82 female FM patients were referred to the study from primary care physicians. All patients were screened via telephone, and 47 of them were deemed eligible for a screening visit at the Karolinska Hospital, Stockholm, Sweden. Patients that were turned down during the telephone screening did not fulfill the inclusion criteria or were unable to participate due to the practical aspects of the study protocol. After the screening visit, 43 patients fulfilled the inclusion criteria and were enrolled in the study (Fig. 1). The mean age was 45.6 years (SD 6.4) and, on average, patients had suffered from FM pain for 11 years (SD 6.7). The inclusion criteria required that patients were 18-55 years of age, female, diagnosed with FM and referred to the study by their primary care physician. To be eligible for the study, all patients had to fulfill the 1990 American College of Rheumatology diagnostic criteria [59] at screening and report a weekly pain intensity of at least 40 mm on a 0-100 visual analogue scale (VAS) anchored with no pain and worst possible pain (Table 1). All patients were screened by an experienced pain clinician (D.K.). Moreover, patients had to fit the criteria for fMRI examinations, excluding all left-handed, pregnant, or breastfeeding patients, as well as patients with metal implants or claustrophobia
Intervention: The CBT program consisted of 12 weekly sessions (approximately 90 minutes each) and was conducted in groups of 6 patients. More specifically, the protocol was based on ACT, pertaining to the third generation of CBT interventions. The treatment program had previously been used for different types of chronic pain, and more details can be found in 2 recent publications [55,56]. However, a brief description of the clinical model is provided. In ACT [22], avoidance of pain and distress is conceptualized as a core problem that substantially contributes to disability and reduced quality of life. According to the theory underlying ACT, avoidance occurs primarily when negative thoughts and emotions have excessive or inappropriate impact on behavior (denoted as cognitive fusion). The core intervention is considered to be exposure to personally important situations and activities that have been previously avoided due to pain and distress, in order to develop new behavioral responses. In contrast to most treatments, which emphasize reduction or control of symptoms, ACT promotes acceptance of negative reactions that cannot be directly changed (thoughts, emotions, bodily sensations) in favor of engaging in activities that are meaningful, though possibly painful or fear provoking (ie, exposure). As part of this process, the patient is also trained to distance him/herself from pain and distress in order to decrease the impact of these experiences on behavior (cognitive de-fusion). In short, ACT seeks to improve functioning and quality of life by increasing psychological flexibility, defined as the ability to act effectively in accordance with personal values in the presence of interfering thoughts, emotions, and bodily sensations [22]. The study psychologists (R.W., M.K.) conducted 10 sessions, and a physician specialized in pain (G.O.) conducted 2 sessions. The 2 psychologists involved in the intervention were trained in CBT. Both the psychologists and the physician had experience, as well as formal training, in ACT. Treatment content followed a clearly written protocol, and patient progress was discussed continuously to maintain treatment fidelity. Control: Waiting list
Pain, Depression, Anxiety, Drop-out
Jensen KB, Kosek E, Wicksell R, Kemani M, Olsson G, Merle JV, et al. Cognitive Behavioral Therapy increases pain-evoked activation of the prefrontal cortex in patients with fibromyalgia. Pain 2012 Jul;153(7):1495-1503.
Sweden. Funding:KJ received support from the Swedish Society for Medical Research (SSMF) and the Swedish Council for Working Life and Social Research. EK received support from the Swedish research council, project # K2009-53X-21070-01-3 and Stockholm County Council. Also, EK and GO were supported by the Swedish Rheumatism Association
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Age18–64 years, being Swedish-speaking, and fulfilment of the 1990 ACR criteria, (generalized pain for more than three months, distributed in all four body quadrants, and at least 11 tenderpoints in typical locations)
Excluded criteria: Major psychiatric or somatic disease, and substance abuse
Pretreatment: There were no significant differences between the two groups in baseline variables
Intervention Characteristics
Intervention
Kontrol
Funktionsevne, Final, MPI-3 (mean, SD)
Smerter, final, MPI-1, pain severity, mean (SD)
Frafald, final, n
Sponsorship source: The Söderström-König Foundation (2003-139), the Swedish Rheumatism Association (51/04), the Swedish Social Insurance Agency (11124), Uppsala County Council (K2003-0036) and Uppsala University (UFV2003/39)
Country: Sweden
Setting: A municipality in Sweden
Authors name: Bo Karlsson
Institution: Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine Section, Uppsala, Sweden
Email: bo.karlsson@pubcare.uu.se
Address: Department of Public Health and Caring Sciences, P.O.Box 564, SE-75122 Uppsala, Sweden.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Women between 25 - 65, meeting ACR criteria for FM for more than 6 months, being stable in regards to the intake of analgesics, antidepressants, or other drugs, sleep and pain, at least 1 month before the study and not being treated with another psychological therapy, and meeting the diagnostic criteria for insomnia
Excluded criteria: Major concomitant medical conditions (e.g inflammatory rheumatic disease, endocrine disturbances, neurological disorder, cancer, recent surgery), pregnant, metal disorders with severe symptoms ( e.g. major depression with suicide ideation schizophrenia, personality disorder, or other organic sleep disorder i.e. apnea having severe dependence of hypnotic drugs and having irregularities in circadian rhythms at the tame of the study
Pretreatment: Groups did not differ in any baseline measures
Intervention Characteristics
Intervention
Kontrol
Smerter, final, PVAS; mean (SD)
frafald, final, n
Sponsorship source: The Spanish Ministry of Science and Innovation and the Spanish Ministry of Economy and Competitiveness
Country: Spain
Setting: Hospital
Authors name: María J. Lami
Institution: Department of Personality, Assessment and Psychiologic Treatment, University of Granada, Gradana, Spain
Email: mjlamih@correo.ugr.es
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: (1) At least 18 years old, (2) documented presence of rheumatologist-diagnosedFM for at least 1 year, (3) meet the revised Wolfeet al 34 ACR criteria for FM, and (4) score on the PCSof at least 21.
Excluded criteria: (1) History of clinically significantanxiety symptoms interfering with fMRI procedures(eg, claustrophobia, panic disorder), (2) recenthistory of cardiac events such as myocardial infarction,(3) history of significant head injury, (4) peripheral neuropathy, (5) use of certain centrallyacting analgesic medications such as opioids, (6) history of substance abuse, (7) concurrent autoimmuneor inflammatory disease, (8) implantedmetallic objects, (9) pregnancy, (10) diseases affectingthe central nervous system (eg, multiple sclerosis, Parkinson’s disease), (11) serious psychiatric conditionsprecluding participation (eg, psychoticdisorders).
Pretreatment: The Education and CBTgroups did not differ at baseline in BPI, PCS, or BDIscores.
Intervention Characteristics
Intervention
Kontrol
Smerter, BPI, mean change (SD)
frafald, final, n
Sponsorship source: Supported by NIH grant R01-AR064367, by grants to RRE from theArthritis Foundation and the American College of Rheumatologyand grant P01-AT006663, R01-AT007550 to VN by the NationalCenter for Complementary and Integrative Health (NCCIH). Theproject was carried out in part at the Athinoula A. Martinos Centerfor Biomedical Imaging at the Massachusetts General Hospital,Charlestown, MA, using resources provided by the Center forFunctional Neuroimaging Technologies, P41EB015896, a P41Biotechnology Resource Grant supported by the National Instituteof Biomedical Imaging and Bioengineering (NIBIB), NationalInstitutes of Health and the KIOM grant K16051.
Country: USA
Setting: Outpatient clinic
Authors name: Asimina Lazaridou
Institution: Departments of Anesthesiology; yMedicine, Division of Rheumatology, Harvard Medical School,
Email: RREdwards@partners.org
Address: Robert R. Edwards, PhD, Brigham Women’s Hospital,Pain Management Center, 850 Boylston St., Chestnut Hill, MA02467 USA
RCT 8 sessions, 6 months follow up
FM patients were recruited from primary health care centers in Zaragoza, Spain. The patients considered for inclusion were aged 18 to 65 years who could speak and read Spanish fluently and who fulfilled the ACR 1990 criteria for FM at screening, with no pharmacological treatment (or agreed to discontinue use to participate in the study) and no previous psychological treatment during the previous year
Intervention: Group based ACT (GACT): This intervention was based on the original program [53] adapted to FM patients. One therapist (JAG) delivered the structured intervention, comprising eight 2.5 h sessions with groups ranging from 10 to 15 patients. The sessions covered specific exercises and topics within the context of ACT practice and training, including various types of formal mindfulness practice (Table 1). At enrollment, the participants were asked to commit to daily homework assignments of 15 to 30 min. The therapist was an experienced clinical psychologist trained in ACT and group management, with clinical experience treating FM patients. All sessions were videorecorded, and 2 authors (YLdH and BO) randomly reviewed 2 sessions in each group of ACT to confirm that the psychological treatment followed the treatment manual. Control: Waiting list, Patients randomized to this condition received no active treatment over the study period but were offered their preferred intervention at the conclusion of the study.
Quality of life, pain, depression, anxiety, catastrophizing, drop-out
Luciano JV, Guallar JA, Aguado J, Lopez-Del-Hoyo Y, Olivan B, Magallon R, et al. Effectiveness of group acceptance and commitment therapy for fibromyalgia: A 6-month randomized controlled trial (EFFIGACT study). Pain 2014 Apr;155(4):693-702.
Spain. Funding: Juan V. Luciano received a research contract from the Institute of Health Carlos III (Red RD06/0018/0017).
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: (a) meet theAmerican College of Rheumatology (ACR) research classification criteria for FM (Wolfe et al. 1990), (b) minimum 18 years of age, (c) adequate reading comprehension, and (d) access to and ability to use a computer.
Excluded criteria: (a) diagnosed with any mental health disorder by a psychiatrist or clinical psychologist in a Public Mental Health Center or Psychiatric ServiceHospital; (b) the presence of suicidal ideation (score 1, 2 or 3 on item 9 of the Beck Depression Inventory (BDI)), (c) prior or present psychological treatment for FM or other chronic pain syndromes, or(d) scheduled for surgery in the next 3 months.
Pretreatment: There were no significant between-group differences
Intervention Characteristics
Intervention
Kontrol
Funktionsevne, SF-36 PF (mean, 95%CI)
Funktionsevne, Final, MPI-3 (mean, SD)
Funktionsevne, final, CPSS, mean (SD)
frafald, final, n
Sponsorship source: Supported by a grant from the Instituto de la Mujer, Ministeriode Sanidad, Servicios Sociales e Igualdad, Spanish Government(Exp. 2011-INV-00232)
Country: Spain
Setting: Hospital
Authors name: Miguel A. Vallejo
Institution: Department of Clinical Psychology, National Distance Education University (UNED), Madrid, Spain
Email: mvallejo@psi.uned.es
Address: Faculty of Psychology, UNED, Juan del Rosal 10, 28040,Madrid, Spain
NKR Bevægeapp on 22/01/2018 06:50
Outcomes
Der er ikke rapporteret 6 og 12 mdr follow up på WL group- Alternativt skal vi afrapporetere på post treatment istedet, men der er der rapporteret på koefficient og standard error. Det er templaten ikke lavet til?
Outcomes
Values given at funktionsevne, final CPSS, mean (SD) are end of treatment. There are no data on control group at any later time points.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
RCT, 3 month FU
Female patients between 18 and 55 years old, fulfilling the American College of Rheumatology classification criteria for FM (Wolfe et al., 1990), and with a weekly self-reported average pain intensity of > 40 (visual analogue scale 0 100), were considered eligible for inclusion in the study. Because functional magnetic resonance imaging (fMRI) exams were performed as part of the research project, all left-handed, pregnant or breastfeeding patients as well as patients with metal implants or claustrophobia were excluded. Also, the use of treatments that could influence the patients pain perception, such as antidepressants and mood stabilizers, analgesics, strong opioids, anticonvulsants, centrally acting relaxants, joint injections, trigger/tender point injections, biofeedback and transcutaneous electrical nerve stimulation, was considered incompatible with participation and had to be discontinued before entering the study. However, small doses of non-steroidal anti-inflammatory drugs were allowed as rescue medication (if discontinued 48 h prior to any study assessments).
Intervention: The ACT intervention consisted of 12 weekly group sessions (90 min each), with 6 participants in each group. Psychologists conducted 10 sessions, and a physician conducted the remaining 2. The two psychologists and the physician who delivered the treatment had training in CBT as well as training and previous experience of using ACT. The intervention followed a clearly written protocol. Treatment content and patient progress were discussed continuously to maintain treatment fidelity. Furthermore, videotaped sessions were analysed to formally assess treatment integrity (see below). If unable to attend a group session, an individual 30-min summary of the missed session was provided prior to the next session. Also, absence from five sessions resulted in exclusion from the study as well as discontinuation of the treatment program. According to ACT theory (Hayes et al., 2006), a narrow and inflexible behaviour pattern characterized by avoidance of pain and distress (i.e., psychological inflexibility) may play a central role in the development of disability and reduced quality of life. The experienced need to avoid psychological events occurs when verbal processes have excessive or inappropriate impact on behaviours, a process denoted as cognitive fusion. Exposure to personally important situations and activities that have been previously avoided due to ongoing or anticipated pain and distress is considered central to treatment and primarily aimed at the acquisition of new behavioural responses. The objective is not to reduce pain or related symptoms, but to increase the ability to act in accordance with personally held values also in the presence of interfering pain and distress (i.e., psychological flexibility). Acceptance (or willingness to experience) is promoted as a behavioural response to pain and distress that cannot be directly changed. Also, the patient learns to step back from thoughts, or in other words to disengage from verbal processes, to decrease the impact of thoughts on behaviour (cognitive defusion). The ACT intervention was organized into four phases, with relatively distinct treatment objectives. In short, the content of the treatment was as follows. In phase 1 (preparing for behavioural change), the dysfunctional character of long-standing pain syndromes was discussed to alter the context in which pain avoidance occurs and to initiate a shift in perspective from symptom reduction to valued living. Phase 2 (shifting perspective) focused on clarification of individual life values. This was combined with an exercise in which the workability of previous strategies to reduce pain and improve functioning was thoroughly evaluated. In essence, the discussion of values and workability of previous strategies served to illustrate the possibility of increasing functioning and life quality by accepting a certain amount of pain and distress. In phase 3 (values-oriented behaviour activation), shortand long-term behavioural goals were defined based on identified life values, followed by a discussion of how to gradually increase previously avoided activities. Phase 4 (acceptance and cognitive defusion) emphasized the utility of a more flexible behavioural repertoire in relation to pain and distress. The participants were encouraged to notice and remain open to unpleasant private experiences when doing so served valued ends. Illustrations and metaphors were commonly used to clarify central concepts, such as psychological flexibility. In-session exercises characterized by exposure to pain and distress provided opportunities for direct experiential learning. Acceptance and defusion strategies were practiced by the participants during in-session exercises as well as in homework assignments carried out between sessions. The ACT intervention was functionally similar to the treatment content described in detail in previous papers (Wicksell et al., 2005, 2008a, 2009, 2007). However, this was the first study to evaluate the protocol as provided using a group format. The full protocol can be retrieved from the first author. Control: Waiting list
Disability, quality of life, pain, depression, anxiety, drop-out
Wicksell RK, Kemani M, Jensen K, Kosek E, Kadetoff D, Sorjonen K, et al. Acceptance and commitment therapy for fibromyalgia: A randomized controlled trial. European Journal of Pain Apr 2013;17(4):599-611.
Sweden. Funding: One author (E. K.) received support from the Swedish Research Council, Project No. K2009-53X-21070-01-3, the Stockholm County Council, and the Swedish Rheumatism Association.
Bernardy K, Klose P, Busch Angela J, Choy Ernest HS, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev 2013;9:CD009796.
Wrong patient population
Wrong patient population
Wrong intervention
Wrong outcomes
Wrong intervention
Wrong study design
Wrong outcomes
Wrong outcomes
Wrong study design
Wrong patient population
Wrong comparator
Wrong patient population
Wrong intervention
Wrong study design
Wrong intervention
Wrong study design
Wrong route of administration
Wrong patient population
Wrong study design
Wrong outcomes
Wrong intervention
Wrong study design
Wrong intervention
Wrong outcomes
Wrong route of administration
Wrong intervention
Wrong study design
Wrong outcomes
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Computer-generated randomization list. A research assistant who was not involved in the study generated the allocation sequence
Quote: "chart of the study population. function ‘ranuni’ that produces random numbers with equal distri- bution, i.e. all numbers appear with the same probability. According to this design for every four consecutive patients two were ran- domly allocated to group 1 and the remaining two were allocated to group 2. The allocations were indicated on"
Judgement Comment: The SAS Function Ranuni was applied for random allocation
Judgement Comment: A number generator was used to allocate participants randomly to the treatments No description on how the randomization was performed. However they describe that a number of generators was used by a researcher blinded to the implementation of the trial.
Judgement Comment: No describtion how randomization was performed Insufficient information about the sequence generation to permit judgement of low or high risk
Computer-generated randomization list. A research assistant who was not involved in the study generated the allocation sequence
Quote: "used a 1:1:1 randomization approach. <b>The patients were randomly assigned by a computer-generated randomization schedule to the WL, CBT, or iCBT groups. The randomization was conducted by a research assistant.</b> There were 2 assessment points"
Not described
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
The sequence was concealed until interventions were assigned. The patients agreed to participate before random allocation and without knowing which reatment they would receive
Quote: "The allocations were indicated on paper sheets and put in sealed envelopes with a patient serial number on the outside. The sheet furthermore had a disturbing text on the backside to prevent reading the allocation through the envelope. The envelopes were stored with the study monitor. When patients were included in the study they were given a serial number, the corresponding serial number envelope was opened and the patient allocation was noted in the study chart."
Judgement Comment: The researcher conducting the number generator was blinded to the implementation of the trial
Judgement Comment: Study participants were informed that they would be randomized to receive “one of two behavioral interventionsto improve quality of life in fibromyalgia patients.”
The sequence was concealed until interventions were assigned. The patients agreed to participate before random allocation and without knowing which reatment they would receive.
Judgement Comment: addressed, but assumed low, due to the computer generalised randomisation
Following the pretreatment assessment, an independent researcher with no insight or involvement in the treatment intervention conducted the randomization using prepared and sealed envelopes with codes for the different study conditions
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Not blinded
Quote: "The patients’ local physicians were informed about the study and were responsible for the every-day care of the patients.
Judgement Comment: The study did not address this outcome
Judgement Comment: Participants didnt know of the difference between the groups. Personal did know the difference
Not possible to blind
Judgement Comment: No blinding of participants or personell was possible
Not blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Particpants are assessors and are not blinded
Judgement Comment: "Self-reported measurements"
Judgement Comment: "self-reported measurements"
Judgement Comment: "It is likely that the investigator have been aware of who was allocated to what, but it is unclear wheter it has influnces outcomes Self-reported measurements"
Particpants are outcome assessors and not possible to blind
Judgement Comment: The particpants are considered outcome assessors as only questionnaires were used.
Participants are outcomes assesors and are not blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
equal dropout rate in each group
Judgement Comment: "Low dropout in each group"
Judgement Comment: No ITT and high dropout rates
Judgement Comment: All participants completed the study
Equal dropout rate in each group
Judgement Comment: 3/20 were lost to follow up in the interventiongroup without further explanations. 0/20 were lost to follow-up in the wailing list group. Intention to treat analysis was performed.
Intervention 4 out of 23 dropped out, control 3 out of 17 dropped out
Reporting bias due to selective outcome reporting
All results are provided
Judgement Comment: "It seems that the published reports include all of the expected outcomes"
Judgement Comment: It seems that the rport includes all expected outcomes
Judgement Comment: It is my understandig that the report include all the expected outcomes
All results are provided
Judgement Comment: It seems that the published reports include all of the expected outcomes
All data reported
Bias due to problems not covered elsewhere in the table
No other bias
Judgement Comment: no conflicts of interest
Judgement Comment: The study appears to be free of other sources of bias
Judgement Comment: The study might be underpowered due to few participants (8+8)
No other bias
Judgement Comment: The study appears to be free of other sources of bias
No other bias