Carmona í Farrés 2019.
Study characteristics | ||
Methods | Randomised controlled with 2 arms
Duration of trial: 10 weeks Country: Spain Setting: outpatient |
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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
Exclusion criteria
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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 |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: no Ethics approval: yes 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 | 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. |