[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention (CBT)
Comparison (sertraline and CBT)
Included criteria:
Excluded criteria:
Pretreatment: ingen sikre forskelle
Intervention Characteristics
Intervention (CBT)
Comparison (sertraline and CBT)
CYBOCS symptomscore End of Treatment
Remission Symptomscore (CYBOCS: ≤9) End of Treatment
>30 % reduktion i CYBOCS follow up
Social funktionsevne: Længste Follow-up
Livskvalitet: Længste Follow-up
Angst : Efter endt Behandling
Adverse Events
Selvmordstanker/Selvmordsadfærd
Sponsorship source: the National Institutes of Health (R01MH078594-01). Pfizer provided sertralineand matching placebo at no cost.
Country: Florida, USA
Setting: Across two study sites with expertise in pediatric OCD treatment
Comments:
Authors name: Storch EA
Institution: Department of pediatrics
Email: estorch@health.usf.edu
Address: 880 6th Street South, St. Petersburg, FL 33701, USA.
Judith Nissen on 02/09/2015 09:05
Baseline Characteristics
Der var ingen baseline forskelle i alder, køn og CYBOCS scores
Judith Nissen on 02/09/2015 09:12
Intervention Characteristics
Patienterne blev randomiseret til 1. regular optitrering med sertralin, 2) langsom optitrering med sertralin og 3) placebo. Efter 4 ugers behandling i en af disse arme fik alle suppleret med CBT over 14 sessioner ialt/samlet 18 uger.Der blev lavet vurderinger til fastsatte tider
Judith Nissen on 02/09/2015 09:17
Continuous Outcomes
Har angivet det efter endt behandling
Judith Nissen on 02/09/2015 09:24
Adverse Outcomes
Der er stor variation og flere af patienterne går igen, dvs de har flere bivirkninger. To SAEs har været set, hvoraf en skulle behandles. Flest AEs i sert gruppen
Birgitte Holm Petersen on 09/09/2015 20:54
Continuous Outcomes
comparison: regular sertraline<COIS-C usedMASC used for anxiety
Birgitte Holm Petersen on 09/09/2015 21:08
Adverse Outcomes
Selvmordstanker/Selvmordsadfærd = suicidal ideation
adult population
adult population
Wrong intervention
Wrong intervention
Wrong intervention
Wrong study design
adult population
Wrong study design
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
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
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.
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.
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.
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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.