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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH098767 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment as usual | Active Comparator | Usual Clinic psychosocial treatment |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interpersonal psychotherapy | Behavioral | Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, PTSD | structured clinical interview: Composite International Diagnostic Interview (CIDI) | Change from 0-12 weeks, 12-24 weeks and 24-36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ARV adherence | Visual Analog Scale self-report | Change from 0-12 weeks, 12-24 weeks and 24-36 weeks |
| HIV viral load | blood draw | 12 weeks, 24 weeks, 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Meffert, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family AIDS Care Education and Services | Kisumu | Nyanza | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33428625 | Derived | 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. | |
| 27463639 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| treatment as usual | Behavioral | Clinic psychosocial treatment as usual |
|
| 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. |
| 26841875 | 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. |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |