[Summary text]
design: randomised controlled trial
sex: 50/50 females (100%)
age: 19.3 years on average (SD = 1.4)
location: USA
setting: outpatient
exclusions: current of lifetime schizophrenia, schizoaffective disorder, bipolar I disorder; current substance dependence (except for nicotine dependence); any type of current psychiatric treatment
level of functioning/severity of illness: mean GAF score at baseline: 53.3, SD = 1.9; i.e. "moderate symptoms (e.g., flat affect and circumstantial speech, occasional panic attacks) OR moderate difficulty in social, occupational, or school functioning (e.g., few friends, conflicts with peers or co-workers)."
mean Sheehan Disability Scale-social impairment score about 4.8; mean vocational impairment subscale score was about 4.3. Scores of 5 or higher are regarded elevated and found to be associated with an increased risk of mental disorder and significant functional impairment (Rush 2005).
BPD diagnosis according to: DSM-IV; all participants were newly diagnosed with BPD
means of assessment: DIB-R, DIPD-IV (both sets of criteria had to be met for inclusion)
group 1 (EG): Psychoeducation workshop (PEW; i.e. latest information on BPD aetiology, phenomenology, co-occurring disorders, treatment options, longitudinal course; the workshop took place within a week of diagnostic disclosure)
group 2 (CG): Waiting List (WL; i.e. subjects were to attend the PEW at the end of the 12-week study)
duration: 12 weeks
concomitant psychotherapy: subjects that were in any type of current psychiatric treatment were not eligible for study participation
concomitant pharmacotherapy: subjects that were in any type of current psychiatric treatment were not eligible for study participation
outcomes considered in this review
self-rated: -
observer-rated: Zanarini rating scale for borderline personality disorder (ZAN-BPD) - impulsivity, Zanarini rating scale for borderline personality disorder (ZAN-BPD) - disturbed relationships score
time-points used here: week 12 (i.e. post-treatment)
analyses: intention-to-treat analysis based on treatment assignment
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Psychotherapy
Control
Included criteria: Subjects were included if they met both DIB-R and DSM-IV criteria for BPD.
Excluded criteria: Excluded if they met current or lifetime criteria for schizophrenia or schizoaffective disorder
Pretreatment: Rate of substance abuse was higher in treatment group compared to control (43% vs. 20%), as well as being hospitilized for psychiatric reasons (10% vs. 0%)
Intervention Characteristics
Psychotherapy
Control
Social functioning, SAS
Borderline severity (Zanarini rating scale, total score)
Impact of symptoms (sheehan disability scale)
Drop-out
Interpersonel problems (zanarini, interpersonel score)
Sponsorship source: Supported by grant MH095818
Country: USA
Comments: Clinical trials NCT01719731
Authors name: Zanarini
Institution: McLean Hospital, dep. of psychiatry
Email: zanarini@mclean.harvard.edu
Address: McLean hospital, 115 Mill St. Belmont, MA 02478
Wrong intervention
trial protocol
Wrong patient population
Book chapter
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
"Using a 3:2 ratio, subjects were either randomized to a workshop that took place within a week of diagnostic disclosure or a waitlist." (Zanarini 2008, p. 286). No further details.
Judgement Comment: Computer-generated list by study statistician, half of subjects allocated to each group, unclear how this was accomplished
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
No further details.
"Fifty subjects were found to meet study criteria for BPD and five who were interviewed did not. These 50 subjects were either randomized to immediate (N = 30) or delayed (N = 20) psychoeducation." (Zanarini 2008, p. 286) No information given about drop-outs during the study course.
Judgement Comment: unclear how
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: After diagnosis disclosure, each subject found out which group she had been randomly assigned to
Detection bias due to knowledge of the allocated interventions by outcome assessors
No information given if assessors were blind to treatment allocation.
Judgement Comment: Subjects not blinded6 self-report measures ZAN-BPD,Severity over time (borderline),Sheehan Disability scale,CUDOS (depression),CUDOS (anxiety),Weissman Social Adj Scale
Attrition bias due to amount, nature or handling of incomplete outcome data
Unclear
Judgement Comment: intervention complete sample 39/40 og i control 38/40.
Reporting bias due to selective outcome reporting
No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
Judgement Comment: Protokol registreret i clinical trials
Bias due to problems not covered elsewhere in the table
More attention spent to EG participants.
No apperant sources of bias