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

NCT ID: NCT02320799

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-01-31

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.

Conditions

Depression; Posttraumatic Stress Disorder; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

treatment as usual

Usual Clinic psychosocial treatment

Group Type: ACTIVE_COMPARATOR

treatment as usual

Intervention Type: BEHAVIORAL

Clinic psychosocial treatment as usual

interpersonal psychotherapy

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

Group Type: EXPERIMENTAL

interpersonal psychotherapy

Intervention Type: BEHAVIORAL

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

Interventions

interpersonal psychotherapy

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

Intervention Type: BEHAVIORAL

treatment as usual

Clinic psychosocial treatment as usual

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan M Meffert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Family AIDS Care Education and Services

Kisumu, Nyanza, Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 33428625 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27463639 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26841875 (View on PubMed)

Other Identifiers

K23MH098767

Identifier Type: NIH

Identifier Source: secondary_id

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1K23MH098767-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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