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

Carmona í Farrés 2019.

Study characteristics
Methods Randomised controlled with 2 arms
  1. Dialectical behavioral therapy ‐ mindfulness

  2. Dialectical behavioral therapy ‐ interpersonal effectiveness


Duration of trial: 10 weeks
Country: Spain
Setting: outpatient
Participants Method of recruitment of participants: Patients for this single‐centre randomised trial were recruited from the outpatient facility of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).
Overall sample size: 70
Diagnosis of borderline personality disorder: Structured clinical interview for DSM IV axis II personality disorders (SCID II)
Means of assessment: Diagnostic interview for borderline (DIB‐R)
Mean age: 31.9 years
Sex: 90% female
Comorbidity: no comorbidity
Inclusion criteria
  1. Borderline personality disorder diagnosis based on 2 semi‐structured interviews

  2. Aged 18–50 years

  3. Not receiving any other type of psychotherapy at the time of study enrollment

  4. No previous training in mindfulness, other meditation‐contemplative practices (e.g. compassion or loving‐kindness practices), or any other mind‐body practice

  5. No comorbidities with any of the following conditions: schizophrenia, drug‐induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course


Exclusion criteria
  1. Comorbidities with any of the following conditions: schizophrenia, drug‐induced psychosis, organic brain syndrome, substance dependence, bipolar disorder, mental retardation, or major depressive episode in course

Interventions Experimental group
Treatment name: dialectical behavioral therapy (DBT) ‐ mindfulness
Number randomised to group: 35
Duration: 10 weeks
Control/comparison group
Comparison name: dialectical behavioral therapy (DBT) ‐ interpersonal effectiveness
Number randomised to group: 35
Duration: 10 weeks
Both groups
Concomitant psychotherapy: not allowed to receive any other type of psychotherapy
Concomitant pharmacotherapy: Patients were allowed to continue taking any medications prescribed prior to study inclusion, provided that no modifications of the medication type or dose were made during the intervention period.
Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes Primary
  1. Borderline personality disorder severity, assessed by the Borderline Symptom List‐23 (BSL)


Secondary
  1. Impulsivity, assessed by the Barrett Impulsiveness Scale‐11 (BIS)

  2. Attrition, in terms of patients lost after randomisation in each group

Notes Sample size calculation: no
Ethics approval: yes
Comments from review authors: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "An independent statistician randomized the participants using a computer‐generated sequence (blocks of four participants without stratification)." (Carmona í Farrés 2019 [pers comm])
Allocation concealment (selection bias) Low risk Quote: "An independent statistician randomized the participants using a computer‐generated sequence (blocks of four participants without stratification), allocation was concealed". (Carmona í Farrés 2019 [pers comm])
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the evaluators of the patients were blinded to the participants' treatment arm throughout the study." (Carmona í Farrés 2019 [pers comm])
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "Analyses were conducted on the per‐protocol sample, comprising participants who completed at least 80% of the intervention and for whom all data points (pre‐ and post‐intervention) were available." (Carmona í Farrés 2019, p. 5) "Analyses of primary outcomes [i.e., DERS, BIS‐11] were also conducted in the intention‐to‐treat (ITT) sample, including all enrolled participants, regardless of whether they completed the intervention or not. Missing data were treated with the last observation carried forward method (Little and Rubin 1987). Further analyses [i.e., BSL‐23] were run only for subjects considered completers." Reported data (means, SDs) which were used for effect size calculation in this review were based on completers. "Of the 70 participants who participated in the study, a total of 18 dropped out: 13 in the DBT‐M group (37.14%) and 7 (20%) from the DBT‐IE group. There were no differences between completers and non‐completers in baseline demographic characteristics." (Carmona í Farrés 2019, p. 6)
Selective reporting (reporting bias) Low risk Comment: Reported outcomes matched study protocol.
Other bias Low risk Allegiance bias: No obvious allegiance bias
Adherence bias: "In relation to treatment adherence, the group sessions were witnessed by video camera, after the session a feedback to the therapists were provided, but there is no available to Spanish any validated DBT adherence tool measurement." (Soler 2019a [pers comm]). Adequate measures taken to ensure treatment adherence.
Attention bias: Equal amounts of attention spent on both groups. Both the DBT‐M and DBT‐IE interventions were delivered in a group format consisting of 9–12 participants. The treatment sessions were 2.5 h in length and held once weekly over a 10‐week period.