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

Smith 2012.

Study characteristics
Methods 36‐week trial with 2 arms
  1. Interpersonal psychotherapy (IPT)

  2. Treatment‐as‐usual (TAU)


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
  1. 18 years or older

  2. English speaking

  3. Current major depression and childhood sexual abuse


Exclusion criteria
  1. Active psychosis

  2. History of schizophrenia or bipolar disorder

  3. Intellectual disability

  4. Substance abuse or dependence within the previous 3 months

  5. Current involvement in psychotherapy

Interventions Experimental groupTreatment name: IPT
Number randomised to group: 17 (out of full sample of 37)
Duration: 36 weeks
Control/comparison groupComparison 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
  1. Depression, assessed by the Beck Depression Inventory

Notes Sample size calculation: yes
Ethics approval: yes
Comments from review authors:
  1. We received additional data on BPD subsamples from Dr Smith on 5 July 2018.

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:
  1. trauma history, assessed with the Childhood Trauma Questionnaire – Short Form, and with the Traumatic Life Events Questionnaire

  2. PTSD symptoms, measured with the Modified PTSD Symptom Scale – Self Report

  3. mental health–related functioning, assessed with the Medical Outcomes Study 36‐Item Short‐Form Health Survey summary score

  4. social functioning, measured by the Social Adjustment Scale–Self Report

  5. shame, assessed with the corresponding subscale of the Differential Emotions Scale


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