Kredlow 2017a.
Study characteristics | ||
Methods | 4‐6 month trial with 2 arms
Duration of trial: 4‐6 months Setting: outpatient clinics |
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Participants |
Method of recruitment of participants: orientation meetings at outpatient centers, referral from clinicians Sample size: 27 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) Mean age: 45.7 years (standard deviation = 9.6) Sex: 96% female Comorbidity: major depressive disorder = 67%, bipolar = 33% Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: CBT
Number randomised to group: 15
Duration: 4‐6 months
Control/comparison group
Comparison name: TAU
Number randomised to group: 12
Duration: 4‐6 months Both groups Concomitant psychotherapy: yes, from local community centers Concomitant pharmacotherapy: yes, from local community centers Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
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Outcomes |
Primary:
Secondary
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Notes |
Sample size calculation: yes Ethics approval: yes Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Randomization was conducted at a central location in the research center by a computer based randomization program with assignments not known in advance by either clinical or research staff.” |
Allocation concealment (selection bias) | Low risk | Quote: “Randomization was conducted at a central location in the research center by a computer based randomization program with assignments not known in advance by either clinical or research staff. When a client had completed the baseline assessment and his or her eligibility for the study was confirmed, the interviewer called the research center and a member of the research team obtained the randomized assignment from the computer. The client was informed about the assignment by the project coordinator”. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quotes: “All assessments were conducted by Masters or Ph.D. level trained clinical interviewers who were blind to treatment assignment.”; “No specific instances of blind breaking were noted in the study”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “There were no differences between the groups on any demographic, diagnostic, or baseline measures, nor in the rates of follow‐up assessments". |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was published and so a clear judgement could not be made. |
Other bias | High risk |
Treatment adherence Quote: “No efforts were made to control or modify any of these services provided to study participants.” Allegiance bias Comment: KT Mueser is on the Committee on Research Agenda of the Association for the Advancement of Behavior Therapy, and the Task Force on Empirically Validated Treatments of the American Psychological Association, Division 12 (www.bu.edu/sargent/files/2013/05/MueserCV.pdf). Attention bias Comment: 12‐16 sessions for EG, no information on length of TAU intervention Vested interest Comment: funded by National Institute of Mental Health |