A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Phase 4

Completed

Conditions: Perinatal Depression
HIV-1-infection

Interventions: Behavioral: Interpersonal therapy
Drug: Sertraline

Registration Number: NCT04094870

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.

Detailed Description: The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal therapy	Interpersonal therapy	Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
Antidepressant medication	Sertraline	Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table

Primary Outcome Measures

Name	Time	Method
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study	6-8 weeks postpartum	MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.
Number of Women Retained in the Study	Enrollment - final visit, approximately 24 weeks after enrollment	Number of women who are enrolled in the study who complete the final study visit
Number of Women Approached Who Agreed to Pre-Screening With EPDS	2-7 weeks postpartum	In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum
Number of Women Pre-Screened Who Have an EPDS Score >/= 6	2-7 weeks postpartum	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \>/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS \>/= 6 out of all of the women who were pre-screened with an EPDS.
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI	2-7 weeks postpartum	MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS \>/=6 were invited to undergo MINI diagnostic testing after signed consent.

Secondary Outcome Measures

Name	Time	Method
Number of Women With a CGI Score Decline of One Point From Baseline	Enrollment - final visit, approximately 24 weeks after enrollment	The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with the patient. Lower scores correlate with clinical improvement.
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)	Enrollment - final visit, approximately 24 weeks after enrollment	Percentage of women randomized to the ADM arm with adequate adherence defined as taking \>90% of pills assessed by pill count and report
Changes in the Viral Load Between Study Entry and the Last Visit	Enrollment - final visit, approximately 24 weeks after enrollment	The mean change in the viral load will be measured between all women enrolled between the first and last visits
Percentage of Women Experiencing Anti Depressant Medication Toxicity	Enrollment - final visit, approximately 24 weeks after enrollment	The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
Acceptability of Trial Participation for Treatment of Postpartum Depression	Enrollment - final visit, approximately 24 weeks after enrollment	Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: "Strongly disagree", "disagree", "neutral", "agree", and "strongly agree". For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral.
Number of Women With an EPDS Score Decline of 3 Points From Baseline	Enrollment - final study visit, approximately 24 weeks after enrollment	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \> 6 is indicative of a woman being at risk of perinatal depression.
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)	Enrollment - final visit, approximately 24 weeks after enrollment	Number of women randomized to the IPT arm who complete all IPT sessions