[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention (DSFT or DBT)
Control (alcohol treatment alone)
Included criteria: Female, age 18–65 years, DSM-IV diagnosis of BPD according to the Structured Clinical Interview for DSM-IV Axis II with at least six diagnostic criteria of BPD present.
Excluded criteria: A DSM-IV diagnosis of bipolar disorder or (chronic) psychotic disorder, insufficientcommand of the Dutch language, and severe cognitive impairment
Intervention Characteristics
Intervention (DSFT or DBT)
Control (alcohol treatment alone)
Behandlingsdeltagelse, antal sessioner (treatment retention, number of sessions)
Behandlingsdeltagelse, antal uger (treatment retention, number of weeks)
Psykiske symptomer (psychiatric symptoms)
Livskvalitet (quality of life)
Selvmordsadfærd (suicide behavior)
Afholdenhed (abstinence)
Alkoholbrug (alcohol use)
Tid til recidiv (time to recidiv)
Frafald fra alkoholbehandlingen (Lost from alcohol treatment)
Funktionsniveau (level of functioning)
Parasuicidal behaviour
Self mutilation
Antal deltagere forsøgt selvmord (number of participants attempted suicide)
Sponsorship source: This work was supported by the Province of Noord-Holland and ZAO Health InsuranceCompany, Amsterdam
Country: The Netherlands
Setting: Addiction treatment and psychiatric services
Comments:
Authors name: Bosch, Koeter, Stijnen, Verheul & van den Brink (2005)
Institution: Forensic Psychiatric Institute Oldenkotte; Amsterdam Institute for Addiction Research; Department of Clinical Psychology, University of Amsterdam; Department of Psychiatry, Academic Medical Center, University of Amsterdam; and more
Email: wiesvdbosch@planet.nl
Address:
Wrong comparator
Wrong intervention
Wrong study design
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.
The condition assignment was quasi-random. Compu- terized randomization was not possible, because it could have resulted in some groups being almost empty and other groups being larger than desirable, due to attrition and the natural flow of clients in the institution. There- fore, a secretary who had never met the clients or seen their test results assigned clients to groups when they were admitted to the institution. Because the secretary had absolutely no knowledge of clients, and because therapists were not able to later reassign clients to other groups, this approach is quasi-random.
Quote: "A minimization method was used to ensure comparability of the two treatment conditions on the following potentially confounding factors: (1) age; (2) severity of borderline symptomatology; (3) severity of drug and alcohol problems; and (4) severity of social problems."
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.
of clients in the institution. <b>There- fore, a secretary who had never met the clients or seen their test results assigned clients to groups when they were admitted to the institution. Because the secretary had absolutely no knowledge of clients, and because therapists were not able to later reassign clients to other groups, this approach is quasi-random. TREATMENT ADHERENCE</b> Each group therapist in both
Quote: "Subjects in the TAU condition (addiction treatment centres n ¼ 11; psychiatric services n ¼ 20) received ongoing outpatient treatment from the original referral source. Since"
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.
Not blinded
Quote: "treatment manual. Subjects in the TAU condition (addiction treatment centres n ¼ 11; psychiatric services n ¼ 20) received ongoing outpatient treatment from the original referral source."
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.
Not blinded
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.
29 of 47 included in the analyses of the intervention group. 30 of 61 included in the analyses of the control group.
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.
No other apparent sources of bias