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

NCT02320799 | Completed

• 2 other identifiers: 1K23MH098767-01A1K23MH098767
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Posttraumatic Stress Disorder; HIV

Keywords

interpersonal psychotherapy; HIV; women; gender based violence; mental health; africa; kenya; global mental health; HIV treatment adherence

Outcome Measures

Primary Outcomes (1)

• Depression, PTSD

  structured clinical interview: Composite International Diagnostic Interview (CIDI)

  Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

Secondary Outcomes (2)

• ARV adherence

  Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

• HIV viral load

  12 weeks, 24 weeks, 36 weeks

Other Outcomes (2)

• cost analyses

  Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

• Neurocognitive outcomes

  Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR

Usual Clinic psychosocial treatment

Behavioral: treatment as usual

interpersonal psychotherapy

EXPERIMENTAL

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

Behavioral: interpersonal psychotherapy

Interventions

interpersonal psychotherapy BEHAVIORAL

Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety

interpersonal psychotherapy

treatment as usual BEHAVIORAL

Clinic psychosocial treatment as usual

treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Family AIDS Care Education and Services

Kisumu, Nyanza, Kenya

Location

Related Publications (3)

• 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.

  PMID: 33428625 DERIVED

• 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.

  PMID: 27463639 DERIVED

• 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.

  PMID: 26841875 DERIVED

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Psychological Well-Being

Interventions

Interpersonal Psychotherapy; Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan M Meffert, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: December 19, 2014
• Study Start: September 1, 2015
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

KE (1)