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

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ClinicalTrials.gov Identifier: NCT02320799
Recruitment Status : Active, not recruiting
First Posted : December 19, 2014
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Depression Posttraumatic Stress Disorder HIV Behavioral: interpersonal psychotherapy Behavioral: treatment as usual Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya
Actual Study Start Date : September 2015
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: treatment as usual
Usual Clinic psychosocial treatment
Behavioral: treatment as usual
Clinic psychosocial treatment as usual

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




Primary Outcome Measures :
  1. Depression, PTSD [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]
    structured clinical interview: Composite International Diagnostic Interview (CIDI)


Secondary Outcome Measures :
  1. ARV adherence [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]
    Visual Analog Scale self-report

  2. HIV viral load [ Time Frame: 12 weeks, 24 weeks, 36 weeks ]
    blood draw


Other Outcome Measures:
  1. cost analyses [ Time Frame: Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]
  2. Neurocognitive outcomes [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320799


Locations
Kenya
Family AIDS Care Education and Services
Kisumu, Nyanza, Kenya
Sponsors and Collaborators
University of California, San Francisco
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Susan M Meffert, MD, MPH University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02320799     History of Changes
Other Study ID Numbers: 1K23MH098767-01A1 ( U.S. NIH Grant/Contract )
K23MH098767 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Keywords provided by University of California, San Francisco:
interpersonal psychotherapy
HIV
women
gender based violence
mental health
africa
kenya
global mental health
HIV treatment adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders