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

Kamalabadi 2012.

Study characteristics
Methods 14‐week trial with 2 arms
  1. Dialectical behavior therapy couple (DBT‐C)

  2. Control group (waiting list)


Duration of trial: 14‐week intervention
Country: Iran
Setting: outpatient
Participants Method of recruitment of participants: referred by psychiatrists of Hafez, Ebne Sina and Razy hospitals in Shiraz
Sample size: 30
Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV)
Means of assessment: Borderline Personality Severity Index ‐ Fourth Version (BPDSI‐IV)
Mean age: not stated
Sex: 100% male
Comorbidity: not stated
Inclusion criteria
  1. Married males with borderline personality disorder

  2. Aged 18‐50 years old


Exclusion criteria
  1. Lifetime diagnosis of schizophrenia

  2. Bipolar disorder

  3. Dissociative identity disorder

  4. Antisocial personality disorder

  5. Drug addiction

  6. Mental retardation

Interventions Experimental groupTreatment name: DBT‐C
Number randomised to group: 15
Duration: 14 weekly sessions
Control/comparison groupComparison name: waiting list
Number randomised to group: 15
Duration: 14 weekly sessions
Both groupsConcomitant psychotherapy: not stated
Concomitant pharmacotherapy: not stated
Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes Primary
  1. BPD severity, assessed by the BPDSI‐IV, total score

  2. Suicide‐related outcome, assessed by BPDSI‐IV, parasuicidal subscale

  3. Psychosocial functioning, assessed by the General Health Questionnaire (GHQ), functioning subscale


Secondary
  1. Anger, assessed by the BPDSI‐IV, anger subscale

  2. Affective instability, assessed by the BPDSI‐IV, affect subscale

  3. Chronic feelings of emptiness, assessed by the BPDSI‐IV, emptiness subscale

  4. Impulsivity, assessed by the BPDSI‐ IV, impulsivity subscale

  5. Interpersonal problems, assessed by the BPDSI‐IV, interpersonal subscale

  6. Abandonment, assessed by the BPDSI‐IV, abandonment subscale

  7. Identity disturbance, assessed by the BPDSI‐IV, identity subscale

  8. Dissociation and psychotic‐like symptoms, assessed by the BPDSI‐IV, dissociation subscale

  9. Depression, assessed by the GHQ, depression subscale

Notes Sample size calculation: not stated
Ethics approval: not stated
Comments from review authors:
  1. Unclear whether this was, in fact, an RCT

  2. A lot of missing information

  3. Underpowered sample

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information on random sequence generation
Allocation concealment (selection bias) Unclear risk Comment: no information provided on allocation concealment
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no clear information provided about blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no information of how many were included and number of dropouts. ANOVA was applied but data analysis was not specified and attrition not reported.
Selective reporting (reporting bias) Unclear risk Comment: no protocol found, therefore we could not assess the risk of bias due to selective reporting.
Other bias High risk Treatment adherence: no clear information provided
Allegiance bias: no indication of bias
Attention bias: more attention paid to the treatment group since control group was waiting list with no intervention
Vested interest: no indication of bias due to vested interests