Linehan 1994.
Study characteristics | ||
Methods | 12‐months trial with 2 arms
Duration of trial: 12 months Country: USA Setting: outpatient |
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Participants |
Methods of recruitment of participants: not stated Sample size: 26 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 3rd Edition (DSM‐III) Means of assessment: Structured Clinical Interview for DSM‐IV (SCID), and Revised Diagnostic Interview for Borderlines (DIB‐R) Mean age: 26.7 years (standard deviation = 7.8) Sex: 100% female Comorbidity: not stated Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group Treatment name: DBT Number randomised to group: 13 Duration: 12 months (weekly individual behavioural psychotherapy, weekly psychoeducational skills training groups) Control/comparison group Comparison name: TAU; participants received alternative therapy referrals and were allowed to participate in any type of treatment available in the community Number randomised to group: 13 Duration: 12 months (weekly individual behavioural psychotherapy, weekly psychoeducational skills training groups) Both groups Concomitant psychotherapy: patients assigned to DBT treatment had to terminate other professional mental healthcare. Concomitant pharmacotherapy: no between‐group differences in number of participants using psychotropic medications at pretreatment (use of: antidepressants, anticonvulsants, lithium, anxiolytics) Proportions of participants taking standing psychotropic medication during trial observation period: DBT participants should have tapered off psychotropic medications as 1 goal of therapy, and 8 out of 13 discontinued medication before start of treatment. The remaining 5 DBT participants reported using a mean of 1.80 medications (sedatives, antidepressants, anxiolytics, lithium) over the treatment year, while 9 out of 13 TAU participants reported using a mean of 3.89 different medications (antidepressants, anxiolytics, neuroleptics, sedatives, anticonvulsants). |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: not stated Ethics approval: not stated Comments from review authors: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quotes: "assignment of subjects to treatment conditions [...] described in detail in the original outcome study [i.e. Linehan 1991]" (p 1772). "Subjects were matched on the number of lifetime parasuicides and psychiatric hospitalization, age, and good vs poor clinical prognosis (with a subthreshold diagnosis on schizophrenia or substance dependence constituting poor prognosis) and randomly assigned to a treatment condition." (Linehan 1991, p 1061) Comment: no further details |
Allocation concealment (selection bias) | Unclear risk | Comments: no further details |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Interviews blind to treatment conditions" (p 1772) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: analyses were conducted on a per protocol basis. 26 women included, data set for 26 participants (DBT: N = 13, TAU: N = 13) provided |
Selective reporting (reporting bias) | Unclear risk | Comment: no indication of selective reporting, but insufficient information to permit judgement of 'high' or 'low' risk of bias |
Other bias | High risk |
Performance bias Comment: no details provided to indicate if supervision or adherence ratings (or both) had been conducted. However, the same study design was used as for Linehan 1991 ("two cohorts", cf. Linehan 1994, p 1772), where regular supervision was explicitely defined (cf. Characteristics of included studies, Risk of bias table for Linehan 1991). Allegiance bias Comment: "study was conducted at the institution where the treatment was developed." (p 1775) Attention bias Comment: more attention paid to DBT group |