A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Antidepressant medication Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table |
Drug: Sertraline
daily SSRI (Sertraline 25mg)
Other Names:
|
Active Comparator: Interpersonal therapy Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization |
Behavioral: Interpersonal therapy
11 sessions over a 24-week period
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
Secondary Outcome Measures
- 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 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 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
- 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
- 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
- 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.
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kamwala District Health Centre | Lusaka | Zambia | ||
2 | University Teaching Hospital | Lusaka | Zambia |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Elizabeth Stringer, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
More Information
Publications
None provided.- 17-3411
- 1R21MH115806
- Z 31801
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Period Title: Overall Study | ||
STARTED | 40 | 40 |
COMPLETED | 39 | 39 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy | Total |
---|---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period | Total of all reporting groups |
Overall Participants | 40 | 40 | 80 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
29.5
(5.5)
|
30.0
(5.3)
|
29.7
(5.4)
|
Sex: Female, Male (Count of Participants) | |||
Female |
40
100%
|
40
100%
|
80
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
40
100%
|
40
100%
|
80
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
40
100%
|
40
100%
|
80
100%
|
White |
0
0%
|
0
0%
|
0
0%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
Zambia |
40
100%
|
40
100%
|
80
100%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Approached Patients |
---|---|
Arm/Group Description | Eligible patients approached for participation |
Measure Participants | 240 |
Count of Participants [Participants] |
240
600%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Approached Patients Who Completed Pre-Screening EPDS |
---|---|
Arm/Group Description | Potentially eligible patients who underwent pre-screening with EPDS |
Measure Participants | 240 |
Count of Participants [Participants] |
199
497.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
199 women were eligible for the MINI based on an EPDS >/= 6. |
Arm/Group Title | All Participants With an EPDS >/=6 |
---|---|
Arm/Group Description | Women eligible for the MINI based on an EPDS >/=6 |
Measure Participants | 199 |
Count of Participants [Participants] |
120
300%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
91 met diagnostic criteria by MINI. |
Arm/Group Title | Women Who Met Diagnostic Criteria by MINI and Agreed to Participate in the Study |
---|---|
Arm/Group Description | Eligible women diagnosed with anxiety or depression based on the MINI who agree to participate |
Measure Participants | 91 |
Count of Participants [Participants] |
80
200%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Measure Participants | 40 | 40 |
Count of Participants [Participants] |
39
97.5%
|
39
97.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Measure Participants | 39 | 39 |
Count of Participants [Participants] |
37
92.5%
|
39
97.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Measure Participants | 39 | 39 |
Count of Participants [Participants] |
38
95%
|
39
97.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Women Assigned to the Antidepressant Medication Arm |
---|---|
Arm/Group Description | All women who were randomized to the medication arm |
Measure Participants | 40 |
Number [percentage of women who discontinued] |
0
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Women Assigned to the Antidepressant Medication Arm |
---|---|
Arm/Group Description | All women who were randomized to the medication arm |
Measure Participants | 40 |
Number [percentage of participants] |
14
35%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Women Assigned to the Therapy Arm |
---|---|
Arm/Group Description | Women who were randomized to the interpersonal therapy arm |
Measure Participants | 40 |
Count of Participants [Participants] |
5
12.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Measure Participants | 39 | 39 |
Satisfaction with the study: Strongly Agree or Agree |
39
97.5%
|
39
97.5%
|
Satisfaction with the intervention received: Strongly Agree or Agree |
37
92.5%
|
37
92.5%
|
Satisfaction with the intervention received: Strongly Disagree or Disagree |
2
5%
|
2
5%
|
Self-perceived improvement of mental health: Strongly Agree or Agree |
39
97.5%
|
39
97.5%
|
Preference for study intervention not received: Strongly Agree or Agree |
6
15%
|
4
10%
|
Preference for study intervention not received: Neutral |
10
25%
|
16
40%
|
Preference for study intervention not received: Strongly Disagree or Disagree |
23
57.5%
|
19
47.5%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy |
---|---|---|
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period |
Measure Participants | 39 | 39 |
Mean (Standard Deviation) [log copies/mL] |
0.6
(4.0)
|
1.6
(3.7)
|
Adverse Events
Time Frame | From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Antidepressant Medication | Interpersonal Therapy | ||
Arm/Group Description | Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) | Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period | ||
All Cause Mortality |
||||
Antidepressant Medication | Interpersonal Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/40 (0%) | ||
Serious Adverse Events |
||||
Antidepressant Medication | Interpersonal Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/40 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Antidepressant Medication | Interpersonal Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 9/40 (22.5%) | 9/40 (22.5%) | ||
Gastrointestinal disorders | ||||
Mild Medication Toxicity - Gastrointestinal | 3/40 (7.5%) | 3 | 0/40 (0%) | 0 |
Nervous system disorders | ||||
Mild medication toxicity - Central nervous system | 4/40 (10%) | 4 | 0/40 (0%) | 0 |
Psychiatric disorders | ||||
Suicidal Ideation | 2/40 (5%) | 2 | 9/40 (22.5%) | 9 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Elizabeth Stringer, MD, MSc |
---|---|
Organization | University of North Carolina at Chapel Hill |
Phone | 919-966-1601 |
elizabeth_stringer@med.unc.edu |
- 17-3411
- 1R21MH115806
- Z 31801