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

Soler 2009.

Study characteristics
Methods 3‐month trial with 2 arms

  1. DBT skills training (DBT‐ST)

  2. Standard group therapy (SGT)


Duration of trial: 3 months
Country: Spain
Setting: outpatient
Participants Methods of recruitment of participants: recruited from the outpatient borderline personality disorder unit at the Department of Psychiatry, Hospital de la Santa Creu i Sant Pau
Sample size: 59
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) and Revised Diagnostic Interview for Borderlines (DIB‐R)
Mean age: 29.2 years
Sex: 81.3% female
Comorbidity: not stated
Inclusion criteria:

  1. Fulfilled diagnostic criteria for borderline personality disorder on SCID‐II and DIB‐R

  2. Aged from 18–45 years (inclusive)


Exclusion criteria

  1. Schizophrenia

  2. Drug‐induced psychosis

  3. Organic brain syndrome

  4. Alcohol or other psychoactive substance dependence

  5. Bipolar disorder

  6. Mental retardation

  7. Major depressive episode in course

  8. CGI‐S score ≤ 4 (i.e. not at all, borderline, or mildly ill)
Interventions Experimental group
Treatment name: DBT‐ST
Number randomised to group: 32
Duration: 3 months (13 psychotherapy sessions of 120 minutes each)
Control/comparison group
Comparison name: SGT
Number randomised to group: 32
Duration: 3 months (13 psychotherapy sessions of 120 minutes each)
Both groups
Concomitant psychotherapy: participants did not receive any other individual or group psychotherapy.
Concomitant pharmacotherapy: pharmacological therapy was continued if initiated prior to inclusion, but type and doses could not be modified during the study period.
Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes Primary:

  1. BPD severity, assessed by the CGI‐BPD

  2. Mental health status, assessed by the Clinical Global Impression (CGI) scale

  3. Suicidality, assessed by the CGI, suicidality subscale


Secondary:

  1. Anger, assessed by the CBI‐BPD item on anger

  2. Affective instability, assessed by the CGI‐BPD item on affective instability

  3. Chronic feelings of emptiness, assessed by the CGI‐BPD item on emptiness

  4. Impulsivity, assessed by the CGI‐BPD item on impulsivity

  5. Interpersonal problems, assessed by the CGI‐BPD item on unstable relations

  6. Dissociative/psychotic pathology, assessed by Brief Psychiatric Rating Scale

  7. Depression, assessed by Hamilton Depression scale 17‐items (Ham‐D‐17)
Notes Sample size calculation: not stated
Ethics approval: The study was approved by the ethics committee of the Hospital de la Santa Creu i Sant Pau and carried out in accordance with the Declaration of Helsinki.
Comments from review authors:

  1. We received information from Dr Soler by email on 15 December 2010.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Blocks of four generated using the SPSS software program served for the randomisation to DBT‐ST or SGT." (p 354)
Allocation concealment (selection bias) Unclear risk Comment: no further details
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quotes: "... participants were evaluated every two weeks by experienced psychiatrists. Subjects were instructed not to disclose any information about the group (topics, group members or therapists) to maintain blind conditions." (p 354); "Assessment and drug control were carried out by two psychiatrists who were masked to the experimental conditions." (p 355); "We are unable to affirm that all participants refrained from disclosing information about the therapy or the therapists with the psychiatric raters during assessment visits. [...] Indeed, the observer‐rater scales obtained during the interview visits and the results from self‐reported measures filled in by patients during the study showed a good concordance." (p 357)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no further details
Selective reporting (reporting bias) Unclear risk Comment: no indication of selective reporting from the published paper, but as there was no protocol available, there was insufficient information to permit judgement of 'high' or 'low' risk of bias
Other bias Unclear risk Comment: no further details