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. 2020 May 4;2020(5):CD012955. doi: 10.1002/14651858.CD012955.pub2

Linehan 1994.

Study characteristics
Methods 12‐months trial with 2 arms
  1. Dialectical behavior therapy (DBT)

  2. Treatment‐as‐usual (TAU)


Duration of trial: 12 months
Country: USA
Setting: outpatient
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
  1. Scored at least 7, out of a maximum score of 10, on the Diagnostic Interview for Borderlines and met DSM‐III criteria for borderline personality disorder

  2. Had at least 2 incidents of parasuicide in the last 5 years, with 1 during the last 8 weeks

  3. Did not meet DSM‐III criteria for schizophrenia, bipolar disorder, substance dependence, or mental retardation

  4. Aged between 18 and 45 years

  5. Agreed to the study conditions, including termination from other individual psychotherapy if assigned to DBT


Exclusion criteria
  1. Participants currently meeting criteria for schizophrenia, bipolar disorder, primary substance dependence, mental retardation

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).
Outcomes Primary
  1. Mental health status, assessed with Goal Attainment Scale (GAS)


Secondary
  1. Anger, assessed with the Søgeresultater Webresultater State‐Trait Anger Expression Inventory (STAXI‐Anger)

Notes Sample size calculation: not stated
Ethics approval: not stated
Comments from review authors: none
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