TITLE: EVALUATION OF TWO COMMUNITY-BASED MENTAL HEALTH INTERVENTIONS FOR AFRO-COLOMBIANS VICTIMS OF VIOLENCE
AUTHORS: Francisco J. Bonilla-Escobar, Andrés Fandiño-Losada, Diana M. Martínez-Buitrago, Julián Santaella-Tenorio, Daniel Tobón-García, Edgar J. Muñoz-Morales, María I. Gutiérrez-Martínez., Judith K. Bass, Laura K. Murray, Paul Bolton, Shannon Dorsey

[DESCRIPTION]
<p>Background: There are mental health consequences for individuals and communities that have been exposed to violence. The armed conflict in Colombia has caused death and massive displacement. In the Pacific region, displacement has been preponderant in Buenaventura and Quibdó. Evidence regarding effectiveness of mental health interventions is lacking in low-income settings, especially in areas with active conflict.<br />Objective: To evaluate two community interventions in mental health designed to decrease symptoms of depression, anxiety, and post-traumatic stress symptoms in Afro-Colombian victims of violence in Buenaventura and Quibdó.<br />Methods: A single-blind randomized controlled trial will be conducted in two municipalities of the Colombian Pacific in which participants will be randomly assigned to a cognitive-behavioral intervention -Common Elements Treatment Approach (CETA) (Group A), a Narrative Community-Based Group Therapy (NCGT) Intervention (Group B) and a control/waiting list group. Assessments of mental health symptoms and dysfunction will be performed at baseline and two weeks after the treatment for Group A and B participants and after three to four months in the control group. Symptoms will be assessed with a validated survey which includes elements from the Hopkins Symptom Checklist, the Harvard Trauma Questionnaire and relevant local symptoms; dysfunction will be assessed with a locally-validated gender-specific scale. Missing values will be handled using multiple imputation methods. Means will be calculated for scales and sub-scales. The primary outcomes will be changes in depression, anxiety and post-traumatic stress symptoms; secondary outcomes will be changes in the Total Mental Health Symptom (TMHS) and dysfunction scales. Differences at baseline will be assessed with the specific test accordingly to the type of variable. Using mixed models we will perform intention to treat analyzes and sensitivity analyzes removing those participants without follow up. Co-variables included in mixed-models will be those significant at the p&lt;0.10 level identified using: 1) simple logistic regressions clustered by counselor to identify baseline differences between intervention and control groups; 2) mixed models to determine interactions between potential co-variables and time on symptoms and dysfunction scores. Furthermore, models will be adjusted for age, gender, education and marital status. Sub-groups analyzed by gender and civil status will be conducted. Extreme values in scales (&gt; or &lt; 4 standard deviations) will be identified as potential outliers and will be excluded in a sensitivity analysis to evaluate its impact on intervention outcomes. Effect sizes will be calculated using Cohen’s d statistic<br /><br />Expected results: Evaluation of the effectiveness of two mental health interventions in order to describe alternatives for treatment in Afro-Colombian victims of violence in the Colombian Pacific Coast.</p>

[STEPS]
?. [Phase 1: Qualitative study of the effects of violence.]
CISALVA Institute staff conducted a pre-intervention qualitative research on the effects of violence on individuals and communities, which included a structured process to identify problems affecting the survivors of violence and their families; JHU staff accompanied the process. The methodology was put in place with a focus on the DIME methodology, which allows a constant monitoring and evaluation process to ensure maximum benefit of the interventions targeted in the study.
?. [Phase 2: Design and validation of instruments based on qualitative data of victims of violence and torture.]
Using the information obtained in the qualitative study as a base and the identification of the problems that seem to be the most severe, frequent, and of highest importance for the population, existing quantitative measuring instruments were selected and adapted with the purpose of achieving a base-line of the problem faced by victims of violence.
?. [Phase 3: Design and pilot testing of interventions.]
In order to offer mental health interventions based on Afro-Colombian victims of violence, the methodology requires a design and validation process so that the objectives are completed and generate an approach in line with the community problems. To do so, two aspects have been defined: Selection and Adaptation of Interventions and Pilot Test of Interventions and Fieldwork.
?. [Phase 4: Implementation and evaluation of interventions (Randomized Controlled Trial).]
A single-blind controlled randomized trial with three parallel groups will be conducted: two intervention groups and one control/waiting list group in each city, powered for comparisons among each intervention against the control group