O'Hara 2019.

Study characteristics
Methods	Study design: RCT, placebo‐controlled, three‐arm parallel group Location: USA Setting: mixed setting including community, obstetric‐gynaecology, paediatric, and mental health clinics, partial hospitalisation programmes No. of centres: 2 (Women and Infants Hospital (WIH) in Rhode Island and the University of Iowa) Dates of study: not reported Total duration of study: 12 weeks Recruitment: not reported Randomisation method: permuted blocks, stratified by site Analysis by ITT: yes Power calculation: not reported
Participants	Inclusion criteria: given birth within previous 6 months, primary DSM‐IV diagnosis of major depressive episode using the SCID, 17‐item HAM‐D score ≥ 15, delivery of a healthy infant, at least 36‐weeks' gestation, 18‐50 years, willing to use acceptable birth control methods. 7 months after recruitment began, the intake criteria were modified to include women in the first year postpartum. Approximately 2½ years after recruitment began HAM‐D‐17 scores for inclusion were decreased from ≥ 15 to ≥ 12 in order to increase recruitment. Exclusion criteria: current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, diagnosis of alcohol or drug abuse or dependence in the past year, current psychotic symptoms, acute suicidal or homicidal risk based on SCID interview, current illegal drug use (based on self‐report or positive urine screen), ongoing treatment with antidepressant medication or psychotherapy, previous trial of IPT with a certified IPT therapist, previous adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily), Contraindications to the use of sertraline (liver transaminase level > 1.25 times normal), abnormal TSH (<0.4 μU/mL or >5.5 μU/mL), Currently pregnant (based on a urine screen). 7 months after recruitment began, the intake criteria were modified to include breast feeding women and the use of sleep medication on an as needed basis (i.e. up to three times per week) was permitted. Number recruited: 162 Number dropped out: sertraline N = 16; placebo N = 9; IPT N = 10 Number analysed: 162: sertraline N = 56; placebo N = 53; IPT N = 53 Age, mean(SD) years: sertraline 28.2 (5.6); placebo 27.3 (5.1); IPT 26.3 (6.1) Severity of PND, mean (SD) HAM‐17 score: sertraline 21.8 (4.7); placebo 22.0 (4.7); IPT 21.9 (4.4) Duration of PND: not reported Physical health co‐morbidities: not reported Mental health co‐morbidities: not reported Ethnicity: % BAME: sertraline 37.5; placebo 47.2; IPT 45.3 Socioeconomic status: no data
Interventions	Women were randomly assigned to 1 of 3 groups: Sertraline + clinical management (56 women) ‐ dosage: flexible depending on response and tolerability. Schedule was 25 mg, increasing to 50 mg at week 1, 100 mg at week 3, 150 mg at week 7 and max. of 200 mg at 11 weeks. 9 clinical management sessions (1 x 50 min, 8 x 20‐30 min); duration: 12 weeks; 10/56 women (17.9%) did not receive intervention. 8/56 (14.3%) discontinued intervention Placebo + clinical management (53 women) ‐ dosage: flexible. Schedule was 25 mg, increasing to 50 mg at week 1, 100 mg at week 3, 150 mg at week 7 and max. of 200 mg at 11 weeks. 9 clinical management sessions (1 x 50 min, 8 x 20‐30 min); duration: 12 weeks; 4/53 women (7.5%) did not receive intervention. 9/53 (17.0%) discontinued intervention. Clinicians delivering the intervention were trained and supervised by two of the authors. Interpersonal psychotherapy (53 women) ‐ dosage: 12 x 50 min sessions; duration: 12 weeks; 7/53 women (13.2%) did not receive intervention. 7/53 (13.2%) discontinued intervention. Clinicians delivering the intervention were at least 5 years experience post‐residency, trained and supervised by the authors. No formal fidelity assessment. Authors described the interpersonal psychotherapy sessions as a manualised intervention. Therapists were supervised monthly by one of the authors using video recordings.
Outcomes	Primary outcome: HAMD‐17 Secondary outcomes: BDI, IDAS‐GD, CGI, PPAQ Time points: 4, 8, and 12 weeks post‐treatment
Notes	This work was funded by NIMH grants R01MH074636 (PI:Stuart) and R01MH074919 (PI:Zlotnick)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"randomly assigned (using the method of permuted blocks) to either IPT (N = 53), sertraline (N = 56), or pill placebo (N = 53). Randomization was stratified by study site (Iowa and WIH) and further stratified within the Iowa site by identification method (use of birth records or direct clinical referral)."
Allocation concealment (selection bias)	Unclear risk	Details of allocation concealment not reported
Blinding of participants (performance bias)	Unclear risk	Antidepressant v placebo: low risk ‐ personnel (and presumably participants) were blind to treatment assignment for placebo vs. sertraline Antidepressant v psychotherapy: high risk ‐ personnel (and presumably participants) were blind to treatment assignment for placebo vs. sertraline. But clinicians were unblinded.
Blinding of personnel (performance bias)	Unclear risk	Antidepressant v placebo: low risk ‐ personnel (and presumably participants) were blind to treatment assignment for placebo vs. sertraline Antidepressant v psychotherapy: high risk ‐ personnel (and presumably participants) were blind to treatment assignment for placebo vs. sertraline. But clinicians were unblinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"All interview assessments were conducted by trained research assistants blinded to treatment condition and were conducted separate from treatment sessions."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Adverse events: unclear risk ‐ slightly more participants lost to follow‐up in antidepressant group (16/56) than placebo (9/53) and psychotherapy (10/53). Some reasons for dropout were reported but majority were 'unknown'. Depression severity: high risk ‐ slightly more participants lost to follow‐up in antidepressant group (16/56) than placebo (9/53) and psychotherapy (10/53). Some reasons for dropout were reported but majority were 'unknown'. All participants included in analyses in paper but data were not extractable. Data extracted from clinicaltrials.gov are completers only Response and remission: low risk ‐ all participants included in analyses.
Selective reporting (reporting bias)	High risk	HAM‐A listed as secondary outcome measure in protocol but IDAS‐GD is measured/reported in paper instead and is only outcome measure with significant group x time interaction (although not extracted for this review). In paper data are reported for 4‐, 8‐ and 12‐week time points, where protocol only specifies 12 weeks, 6 months and 9 months (from baseline).
Other bias	Unclear risk	Sertraline and placebo pills were provided by Pfizer, Inc. but no funding provided by pharmaceutical company. 1 author is the owner of and receives compensation from IPT institute. No data reported on medication adherence among completers. More participants in antidepressant group did not receive intervention or discontinued (32.2%) compared with placebo (24.5%) and IPT (26.4%)