HIV-1-infection, Perinatal Depression
Conditions
Keywords
perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy
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.
Interventions
DRUGSertraline
daily SSRI (Sertraline 25mg)
BEHAVIORALInterpersonal therapy
11 sessions over a 24-week period
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antidepressant Medication Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
Sertraline: daily SSRI (Sertraline 25mg) | 40 |
| Interpersonal Therapy 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 | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Antidepressant Medication | Total | Interpersonal Therapy |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 5.5 | 29.7 years STANDARD_DEVIATION 5.4 | 30.0 years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 80 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 80 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 9 / 40 | 9 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
Time frame: 2-7 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women Approached Who Agreed to Pre-Screening With EPDS | 240 Participants |
Primary
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.
Time frame: 2-7 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women Pre-Screened Who Have an EPDS Score >/= 6 | 199 Participants |
Primary
Number of Women Retained in the Study
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women Retained in the Study | 39 Participants |
| Interpersonal Therapy | Number of Women Retained in the Study | 39 Participants |
Primary
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.
Time frame: 2-7 weeks postpartum
Population: 199 women were eligible for the MINI based on an EPDS \>/= 6.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI | 120 Participants |
Primary
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.
Time frame: 6-8 weeks postpartum
Population: 91 met diagnostic criteria by MINI.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study | 80 Participants |
Secondary
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.
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the study: Strongly Agree or Agree | 39 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Strongly Agree or Agree | 6 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Neutral | 10 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the intervention received: Strongly Agree or Agree | 37 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the intervention received: Strongly Disagree or Disagree | 2 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Self-perceived improvement of mental health: Strongly Agree or Agree | 39 Participants |
| Approached Patients | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Strongly Disagree or Disagree | 23 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the intervention received: Strongly Agree or Agree | 37 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Self-perceived improvement of mental health: Strongly Agree or Agree | 39 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Strongly Agree or Agree | 4 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the intervention received: Strongly Disagree or Disagree | 2 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Strongly Disagree or Disagree | 19 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Satisfaction with the study: Strongly Agree or Agree | 39 Participants |
| Interpersonal Therapy | Acceptability of Trial Participation for Treatment of Postpartum Depression | Preference for study intervention not received: Neutral | 16 Participants |
Secondary
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
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Approached Patients | Changes in the Viral Load Between Study Entry and the Last Visit | 0.6 log copies/mL | Standard Deviation 4 |
| Interpersonal Therapy | Changes in the Viral Load Between Study Entry and the Last Visit | 1.6 log copies/mL | Standard Deviation 3.7 |
Secondary
Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Number of women randomized to the IPT arm who complete all IPT sessions
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT) | 5 Participants |
Secondary
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.
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women With a CGI Score Decline of One Point From Baseline | 38 Participants |
| Interpersonal Therapy | Number of Women With a CGI Score Decline of One Point From Baseline | 39 Participants |
Secondary
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.
Time frame: Enrollment - final study visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached Patients | Number of Women With an EPDS Score Decline of 3 Points From Baseline | 37 Participants |
| Interpersonal Therapy | Number of Women With an EPDS Score Decline of 3 Points From Baseline | 39 Participants |
Secondary
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
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Approached Patients | Percentage of Women Experiencing Anti Depressant Medication Toxicity | 0 percentage of women who discontinued |
Secondary
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
Time frame: Enrollment - final visit, approximately 24 weeks after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Approached Patients | Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM) | 14 percentage of participants |