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A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Primary Purpose

Perinatal Depression, HIV-1-infection

Status
Completed
Phase
Phase 4
Locations
Zambia
Study Type
Interventional
Intervention
Sertraline
Interpersonal therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Depression focused on measuring perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • 18 years of age or older
  • Documentation of confirmed HIV-1 infection
  • Six to eight weeks postpartum
  • Currently taking ART treatment
  • Able and willing to provide written informed consent
  • Willing to adhere to study visit schedule
  • PND diagnosis confirmed by Mini-International Neuropsychiatric Interview

Exclusion criteria:

  • Taking an ADM in the prior 12 months prior to enrollment
  • Actively suicidal
  • Known or suspected allergy or contraindication to first line Sertraline
  • Any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.

Sites / Locations

  • Kamwala District Health Centre
  • University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antidepressant medication

Interpersonal therapy

Arm Description

Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table

Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization

Outcomes

Primary Outcome Measures

Number of Women Approached Who Agreed to Pre-Screening With EPDS
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
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
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.
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
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
Number of women who are enrolled in the study who complete the final study visit

Secondary Outcome Measures

Number of Women With an EPDS Score Decline of 3 Points From Baseline
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 With a CGI Score Decline of One Point From Baseline
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 Experiencing Anti Depressant Medication Toxicity
The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Number of women randomized to the IPT arm who complete all IPT sessions
Acceptability of Trial Participation for Treatment of Postpartum Depression
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.
Changes in the Viral Load Between Study Entry and the Last Visit
The mean change in the viral load will be measured between all women enrolled between the first and last visits

Full Information

First Posted
September 16, 2019
Last Updated
October 12, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04094870
Brief Title
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Official Title
Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, HIV-1-infection
Keywords
perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antidepressant medication
Arm Type
Active Comparator
Arm Description
Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
Arm Title
Interpersonal therapy
Arm Type
Active Comparator
Arm Description
Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
SSRI
Intervention Description
daily SSRI (Sertraline 25mg)
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal therapy
Intervention Description
11 sessions over a 24-week period
Primary Outcome Measure Information:
Title
Number of Women Approached Who Agreed to Pre-Screening With EPDS
Description
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
Time Frame
2-7 weeks postpartum
Title
Number of Women Pre-Screened Who Have an EPDS Score >/= 6
Description
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.
Time Frame
2-7 weeks postpartum
Title
Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
Description
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.
Time Frame
2-7 weeks postpartum
Title
Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
Description
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.
Time Frame
6-8 weeks postpartum
Title
Number of Women Retained in the Study
Description
Number of women who are enrolled in the study who complete the final study visit
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Secondary Outcome Measure Information:
Title
Number of Women With an EPDS Score Decline of 3 Points From Baseline
Description
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.
Time Frame
Enrollment - final study visit, approximately 24 weeks after enrollment
Title
Number of Women With a CGI Score Decline of One Point From Baseline
Description
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.
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Title
Percentage of Women Experiencing Anti Depressant Medication Toxicity
Description
The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Title
Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
Description
Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Title
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Description
Number of women randomized to the IPT arm who complete all IPT sessions
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Title
Acceptability of Trial Participation for Treatment of Postpartum Depression
Description
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.
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment
Title
Changes in the Viral Load Between Study Entry and the Last Visit
Description
The mean change in the viral load will be measured between all women enrolled between the first and last visits
Time Frame
Enrollment - final visit, approximately 24 weeks after enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 18 years of age or older Documentation of confirmed HIV-1 infection Six to eight weeks postpartum Currently taking ART treatment Able and willing to provide written informed consent Willing to adhere to study visit schedule PND diagnosis confirmed by Mini-International Neuropsychiatric Interview Exclusion criteria: Taking an ADM in the prior 12 months prior to enrollment Actively suicidal Known or suspected allergy or contraindication to first line Sertraline Any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stringer, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamwala District Health Centre
City
Lusaka
Country
Zambia
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
35803896
Citation
Spelke MB, Paul R, Blette BS, Meltzer-Brody S, Schiller CE, Ncheka JM, Kasaro MP, Price JT, Stringer JSA, Stringer EM. Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial. J Int AIDS Soc. 2022 Jul;25(7):e25959. doi: 10.1002/jia2.25959.
Results Reference
derived

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A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

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