Smith 2012.
Study characteristics | ||
Methods | 36‐week trial with 2 arms
Duration of trial: 36 weeks Country: USA Setting: inpatient and outpatient |
|
Participants |
Method of recruitment of participants: " In total, 1,100 women seeking treatment in the clinic were screened by intake clinicians for study eligibility on the basis of presence of depressive symptoms and self‐ report of sexual abuse before age 18 and absence of exclusion criteria." (quote, p 2)
Sample size: subsample = 70 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) Mean age: no data for subsample. Full sample = 36.39 years (standard deviation = 9.86) Sex: 100% female Comorbidity: no data for subsample Inclusion criteria
Exclusion criteria
|
|
Interventions |
Experimental group
Treatment name: IPT
Number randomised to group: 17 (out of full sample of 37)
Duration: 36 weeks Control/comparison group Comparison name: TAU Number randomised to group: 9 (out of full sample of 33) Duration: 36 Both groups Concomitant psychotherapy: “TAU was individual psychotherapy, TAU therapists described as supportive (53%), cognitive‐behavioral or dialectical‐behavioral (27%), integrated/eclectic (13%), and client‐centered (7%)” (quote, p 4) Concomitant pharmacotherapy: “Women were permitted to enter the study regardless of antidepressant prescription status. A total of 43 women reported having been prescribed antidepressant medications at the baseline assessment (23 of those in the IPT condition, 20 of those in the TAU condition).” (p 125) Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
|
Outcomes |
Secondary
|
|
Notes |
Sample size calculation: yes
Ethics approval: yes Comments from review authors:
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no clear information on randomisation procedure was available |
Allocation concealment (selection bias) | Unclear risk | Comment: no clear information on allocation concealment was provided |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "One master’s‐level research assistant, who was aware of patients’ treatment assignments, conducted all assessments." (p 125) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “In intention‐to‐treat analyses, change over time was assessed with generalized linear models with inference based on generalized estimating equations (GEEs) (32). To test the assumption that data were missing completely at random (MCAR), logistic modeling was performed to determine whether missing assessment data depended on individual patients’ observed responses in previous assessments (Table 2). When the probability of missing values was modeled for each outcome, we found that the shame subscale of the Differential Emotions Scale had informative dropout (P=.04) and violated the MCAR assumption. In that case, weighted GEEs were applied with individual weights estimated from the logistic model for missing data. Women with lower shame scores in earlier assessments were more likely to have missing data in later assessments.” |
Selective reporting (reporting bias) | High risk |
Comment: extra outcomes included in full report, but not mentioned in the protocol are:
Several outcomes included in full report. Not addressed. No clear differences between primary and secondary outcomes such as in protocol |
Other bias | High risk |
Attention bias Quote: "Interpersonal psychotherapy participants attended approximately twice as many sessions (12.9±6.5) as those in usual care (6.3±4.2), a significant between‐group difference". (p 127) Adherence bias Comment: all interpersonal psychotherapy sessions were audiotaped or videotaped. The principal investigator reviewed 20% of taped sessions for treatment fidelity and addressed deviations from the model with the therapist. (See p 126) Allegiance bias Comment: none found |