[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
CBT
CBT + SSRI
Included criteria: DSM-3 criteria for OCDA 15 day wash-out period preceeded biological and behavioural assessments.A secondary diagnosis of major depression was acceptable if it had been preceeded by OCD
Excluded criteria: Gilles de la Tourettee disorderorganic mental disodersSchizophreniaAdditional treatmentNo
Pretreatment: No significant differences between groups at baseline
Intervention Characteristics
CBT
CBT + SSRI
Symptomscore (Y-BOCS) End of treatment
Social funktionsevne Længste follow-up
Livskvalitet Længste follow-up
Depression End of treatment
Drop-out End of treatment
Remission symptomscore (Y-BOCS: ≤9) End of treatment
Symptomscore (min 30% reduktion i Y-BOCS) Længste follow-up
Selvmordstanker/Selvmordsadfærd End of Treatment
Frafald på grund af bivirkninger (AE) End of treatment
Andre alvorlige bivirkninger (SAE) End of treatment
Sponsorship source: Grant from INSERM and DUPHAR-FRANCE and "Les Hospices Civils de Lyon"
Country: France
Setting: Hospital
Comments:
Authors name: Jean Cottraux
Institution: Laboratoire de Psychologie Medicale
Email: not reported
Address: Laboratoire de Psychologie Medicale, Hopital Neurologiique, 59 boulevard Pinel, 69394 Lyon, France
Birgitte Holm Petersen on 24/09/2015 21:43
Study Design
Interventionen:ExposureComparison: Exposure + fluvoxamin
Birgitte Holm Petersen on 25/09/2015 02:29
Continuous Outcomes
HRSD for depression afrapporteret
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
CBT
CBT + SSRI
Included criteria: OCD diagnosisY-BOCS exceed 16 points
Excluded criteria: Current or lifetime diagnosis of psychotic disorder, druge or alcohol abuse, organic psychosydromes, epilepsy, acute sucidial tendencies
Pretreatment: No differences
Intervention Characteristics
CBT
CBT + SSRI
Symptomscore (Y-BOCS) End of treatment
Social funktionsevne Længste follow-up
Livskvalitet Længste follow-up
Depression End of treatment
Drop-out End of treatment
Remission symptomscore (Y-BOCS: ≤9) End of treatment
Symptomscore (min 30% reduktion i Y-BOCS) Længste follow-up
Selvmordstanker/Selvmordsadfærd End of Treatment
Frafald på grund af bivirkninger (AE) End of treatment
Andre alvorlige bivirkninger (SAE) End of treatment
Sponsorship source: not reported
Country: Germany
Setting: Psychiatric - multicentre
Comments: 8 ugers BT og medicinsk forløb - relativt kort for begge arme. Dog ser det ud til at de fik flere terapi sessioner om ugen, så de har nok fået flere end blot 8 sessioner.
Authors name: F. Hohagen
Institution: Multicentre
Email: NR
Address: Psychiatric Department of the University of Freiburg, Hauptsr. 5, 79104 Freiburg Germany
Birgitte Holm Petersen on 25/09/2015 02:48
Study Design
Intervention: BT + fluvoxaminComparison: BT
Hjalti Jonsson on 25/09/2015 21:33
Continuous Outcomes
depressions chance score større ved BT gruppen - men slut score højere. Højere præ-score i BT gruppen.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
CBT
CBT + SSRI
Included criteria: Ages of 18-65, who meet DSM-III-R criteria for OCD with a duration of at least 1 year.
Excluded criteria: Obsessions only, organic mental disorders, psychotic disorders, psychoactive substance abuse disorders, mental retardation, severe medical disorders
Pretreatment: No significant differences were observed
Intervention Characteristics
CBT
CBT + SSRI
Symptomscore (Y-BOCS) End of treatment
Social funktionsevne Længste follow-up
Livskvalitet Længste follow-up
Depression End of treatment
Drop-out End of treatment
Remission symptomscore (Y-BOCS: ≤9) End of treatment
Symptomscore (min 30% reduktion i Y-BOCS) Længste follow-up
Selvmordstanker/Selvmordsadfærd End of Treatment
Frafald på grund af bivirkninger (AE) End of treatment
Andre alvorlige bivirkninger (SAE) End of treatment
Sponsorship source: Grant of Duphar Nederland
Country: Netherlands
Setting: Psychiatric outpatient setting
Comments:
Authors name: Van Balkom et al.
Institution: Department of Psychiatry, Insitute for Research in Extramural medicine
Email:
Address: Valeriusplein 9, 1075 BG Amsterdam, The Netherlands
Birgitte Holm Petersen on 25/09/2015 04:27
Adverse Outcomes
0% versus 17% of the patients reported more somnolence after 8 weeks of treatment with fluvoxamine
Hjalti Jonsson on 25/09/2015 22:18
Adverse Outcomes
9 due to side effects, one of these patients became suicidal - samlet for begge fluvoxamin grupperne - men de rapporterer ikke hvor mange i hver gruppe desværre
Wrong comparator
Wrong intervention
Wrong study design
Wrong comparator
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
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Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
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Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
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Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
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Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
include only completer patients
11 patients were excluded after randomization because they were outliers
only completer analysis
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.