Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial.

BACKGROUND: HIV-positive women suffer a high burden of mental disorders due in part to gender-based violence (GBV). Comorbid depression and posttraumatic stress disorder (PTSD) are typical psychiatric consequences of GBV. Despite attention to the HIV-GBV syndemic, few HIV clinics offer formal mental healthcare. This problem is acute in sub-Saharan Africa, where the world's majority of HIV-positive women live and prevalence of GBV is high. METHODS AND FINDINGS: We conducted a randomized controlled trial at an HIV clinic in Kisumu, Kenya. GBV-affected HIV-positive women with both major depressive disorder (MDD) and PTSD were randomized to 12 sessions of interpersonal psychotherapy (IPT) plus treatment as usual (TAU) or Wait List+TAU. Nonspecialists were trained to deliver IPT inside the clinic. After 3 months, participants were reassessed, and those assigned to Wait List+TAU were given IPT. The primary outcomes were diagnosis of MDD and PTSD (Mini International Neuropsychiatric Interview) at 3 months. Secondary outcomes included symptom measures of depression and PTSD, intimate partner violence (IPV), and disability. A total of 256 participants enrolled between May 2015 and July 2016. At baseline, the mean age of the women in this study was 37 years; 61% reported physical IPV in the past week; 91% reported 2 or more lifetime traumatic events and monthly income was 18USD. Multilevel mixed-effects logistic regression showed that participants randomized to IPT+TAU had lower odds of MDD (odds ratio [OR] 0.26, 95% CI [0.11 to 0.60], p = 0.002) and lower odds of PTSD (OR 0.35, [0.14 to 0.86], p = 0.02) than controls. IPT+TAU participants had lower odds of MDD-PTSD comorbidity than controls (OR 0.36, 95% CI [0.15 to 0.90], p = 0.03). Linear mixed models were used to assess secondary outcomes: IPT+TAU participants had reduced disability (-6.9 [-12.2, -1.5], p = 0.01), and nonsignificantly reduced work absenteeism (-3.35 [-6.83, 0.14], p = 0.06); partnered IPT+TAU participants had a reduction of IPV (-2.79 [-5.42, -0.16], p = 0.04). Gains were maintained across 6-month follow-up. Treatment group differences were observed only at month 3, the time point at which the groups differed in IPT status (before cross over). Study limitations included 35% attrition inclusive of follow-up assessments, generalizability to populations not in HIV care, and data not collected on TAU resources accessed. CONCLUSIONS: IPT for MDD and PTSD delivered by nonspecialists in the context of HIV care yielded significant improvements in HIV-positive women's mental health, functioning, and GBV (IPV) exposure, compared to controls. TRIAL REGISTRATION: Clinical Trials Identifier NCT02320799.

Low socioeconomic status is associated with lower weight-loss outcomes 10-years after Roux-en-Y gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is the criterion standard operation for weight loss. Low socioeconomic status (SES) is common in the Veteran population undergoing bariatric surgery, but the impact of SES on long-term weight-loss outcomes is not known. We hypothesize that low socioeconomic status is associated with less weight loss after gastric bypass in long-term follow-up. METHODS: We performed a retrospective review of patients undergoing RYGB at a single Veterans Affairs (VA) hospital. Patients with at least 10 years of follow-up data in the electronic health record were included in the analysis. Weight loss was measured as percent excess body mass index loss (%EBMIL). The primary predictor variable, median household income, was determined using zip codes of patient residences matched to publicly available 2010 U.S. census data. Univariate relationships between income, weight loss, and other patient characteristics were evaluated. We calculated a multivariate generalized linear model of %EBMIL to estimate independent relationships with median household income quartile while controlling for patients' age, race, sex, and VA distance. RESULTS: Complete 10-year follow-up data were available for 83 of 92 patients (90.2%) who underwent RYGB between 2001 and 2007 and survived at least 10 years. The majority of patients were male (79.5%) and white (73.5%). The mean 10-year %EBMIL was 57.8% (SD: 29.5%, range - 36.0% - 132.8%). In univariate analysis, income was significantly associated with race (p < 0.001) and median distance to the VA bariatric center (p = 0.034), but income did not differ by gender (p = 0.73) or age (p = 0.45). Multivariate analysis revealed significantly lower 10-year %EBMIL for patients with the lowest income compared to patients with low-mid income (p = 0.03) and mid-high income (p = 0.01), after controlling for gender, race, age, and VA distance. CONCLUSIONS: Low socioeconomic status is associated with lower weight-loss outcomes, 10 years after RYGB. Durable weight loss is observed in all income groups.

Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya.

BACKGROUND: Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN: We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION: The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.