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Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya

Primary Purpose

Depression, Posttraumatic Stress Disorder, HIV

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
interpersonal psychotherapy
treatment as usual
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring interpersonal psychotherapy, HIV, women, gender based violence, mental health, africa, kenya, global mental health, HIV treatment adherence

Eligibility Criteria

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

Inclusion Criteria:

  • .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent.

Exclusion Criteria:

  • (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT**; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.

Sites / Locations

  • Family AIDS Care Education and Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

treatment as usual

interpersonal psychotherapy

Arm Description

Usual Clinic psychosocial treatment

Interpersonal Psychotherapy is an evidence-based structured, brief psychotherapy which focuses on improving relationships in order to improve mood and reduce anxiety.

Outcomes

Primary Outcome Measures

Depression, PTSD
structured clinical interview: Composite International Diagnostic Interview (CIDI)

Secondary Outcome Measures

ARV adherence
Visual Analog Scale self-report
HIV viral load
blood draw

Full Information

First Posted
September 9, 2014
Last Updated
April 29, 2019
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02320799
Brief Title
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
Official Title
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes. Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone. Hypothesis 2: IPT+TAU will be acceptable and feasible.
Detailed Description
We will use a parallel design with FACES Treatment as Usual (TAU) control to provide IPT once per week for twelve weeks to HIV+GBV+ women meeting CIDI diagnostic criteria for depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV. Blocked randomization will be used to evenly distribute 120 participants to (1) IPT + TAU or (2) TAU for 12 weeks. The TAU group will be offered IPT treatment following the initial 12 week trial. Thus, all study subjects will receive TAU throughout the study and they will all receive IPT in either the first or second half of the study. My research team at FACES will be recruited for IPT training as potential therapists in the IPT pilot. A run-in study design will be used, assigning one training case apiece to each of the 8 therapists to practice IPT skills. Both IPT + TAU and TAU groups will be measured at baseline and weeks 12, 24 and 36 by blinded assessment. At FACES, TAU resources for HIV+GBV+ women include medical professionals, counseling, community elders, church leaders, police, and a pro-bono legal aid, all of who have all been involved with past FACES GBV interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Posttraumatic Stress Disorder, HIV
Keywords
interpersonal psychotherapy, HIV, women, gender based violence, mental health, africa, kenya, global mental health, HIV treatment adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
Usual Clinic psychosocial treatment
Arm Title
interpersonal psychotherapy
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy is an evidence-based structured, brief psychotherapy which focuses on improving relationships in order to improve mood and reduce anxiety.
Intervention Type
Behavioral
Intervention Name(s)
interpersonal psychotherapy
Intervention Description
Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety
Intervention Type
Behavioral
Intervention Name(s)
treatment as usual
Intervention Description
Clinic psychosocial treatment as usual
Primary Outcome Measure Information:
Title
Depression, PTSD
Description
structured clinical interview: Composite International Diagnostic Interview (CIDI)
Time Frame
Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
Secondary Outcome Measure Information:
Title
ARV adherence
Description
Visual Analog Scale self-report
Time Frame
Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
Title
HIV viral load
Description
blood draw
Time Frame
12 weeks, 24 weeks, 36 weeks
Other Pre-specified Outcome Measures:
Title
cost analyses
Time Frame
Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
Title
Neurocognitive outcomes
Time Frame
Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent. Exclusion Criteria: (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT**; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M Meffert, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family AIDS Care Education and Services
City
Kisumu
State/Province
Nyanza
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
33428625
Citation
Meffert SM, Neylan TC, McCulloch CE, Blum K, Cohen CR, Bukusi EA, Verdeli H, Markowitz JC, Kahn JG, Bukusi D, Thirumurthy H, Rota G, Rota R, Oketch G, Opiyo E, Ongeri L. Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial. PLoS Med. 2021 Jan 11;18(1):e1003468. doi: 10.1371/journal.pmed.1003468. eCollection 2021 Jan.
Results Reference
derived
PubMed Identifier
27463639
Citation
Opiyo E, Ongeri L, Rota G, Verdeli H, Neylan T, Meffert S. Collaborative Interpersonal Psychotherapy for HIV-Positive Women in Kenya: A Case Study From the Mental Health, HIV and Domestic Violence (MIND) Study. J Clin Psychol. 2016 Aug;72(8):779-83. doi: 10.1002/jclp.22359. Epub 2016 Jul 27.
Results Reference
derived
PubMed Identifier
26841875
Citation
Onu C, Ongeri L, Bukusi E, Cohen CR, Neylan TC, Oyaro P, Rota G, Otewa F, Delucchi KL, Meffert SM. Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial. Trials. 2016 Feb 3;17:64. doi: 10.1186/s13063-016-1187-6. Erratum In: Trials. 2016;17(1):151.
Results Reference
derived

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Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya

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