Depression Clinical Trial
— ACOPLEOfficial title:
Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
Verified date | March 2021 |
Source | Universidad del Valle, Colombia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a community prevention randomized trial with three parallel groups: two intervention groups and one control group in Buenaventura and Quibdó. The aim of the trial is to evaluate the impact of two community interventions on mental health; the intervention groups are designed to decrease depression, anxiety, post-traumatic stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims of violence. Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in both cities will participate in the enter survey. The subjects will be selected based on the severity of symptoms, traumatic experiences and a level of dysfunction identified using the instruments of this research (i.e. those obtaining an score equal or higher than 49 in symptoms (25% of the total of symptoms)). The fieldwork and the interventions will be conducted by people belonging to the community; they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal training, they will be able to perform two kinds of interventions, Common Elements Treatment Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group Therapy (NCGT), for the people affected by violence and displacement that were pre-selected according to the baseline instrument. The LPCW will be under the constant supervision by psychologists of the project, and under weekly supervision by a group of experts from Johns Hopkins University, the Heartland Alliance and The Institute for Research and Development in Violence Prevention and Promotion of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the waiting control group. The study subjects will follow their allocated treatment, or waiting in the control group, for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks after the last session of therapy. The study outcome is the differences in instrument scores between the follow-up and the baseline among the interventions (CETA or NCGT) and control group. Control subjects will be assessed by the project psychologist after the follow-up, and they will receive treatment when necessary.
Status | Completed |
Enrollment | 521 |
Est. completion date | June 2014 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (18 years of age or older) Afro-Colombian victims of violence and torture who have expressed sadness, suffering psychological trauma caused by violence and when the situation was known by the leaders of Afro-Colombian Displaced Association (AFRODES) or the community leaders contacted by the research team. - Persons with a total symptomatic value greater than or equal to 49 points in the study instrument, with the presence of trauma from violence, and a loss of functionality score greater than zero. - Individuals who signed the informed consent. Exclusion Criteria: - People of ethnicities other than Afro-Colombian. - Children under 18 years old. - Persons who present symptoms of severe mental illness such as schizophrenia, psychotic episodes, suicidal attempters, and those who potentially could harm others. - Anyone who is related with the counselors (LPCW). |
Country | Name | City | State |
---|---|---|---|
Colombia | Centro ACOPLE de Buenaventura | Buenaventura | Valle Del Cauca |
Colombia | Centro ACOPLE de Quibdó | Quibdó | Chocó |
Lead Sponsor | Collaborator |
---|---|
Universidad del Valle, Colombia | Afrocolombian Displaced Association - AFRODES, Heartland Alliance, Johns Hopkins Bloomberg School of Public Health, United States Agency for International Development (USAID) |
Colombia,
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Murray LK, Tol W, Jordans M, Zangana GS, Amin AM, Bolton P, Bass J, Bonilla-Escobar FJ, Thornicroft G. Dissemination and implementation of evidence based, mental health interventions in post conflict, low resource settings. Intervention (Amstelveen). 2014 — View Citation
Osorio-Cuellar GV, Pacichana-Quinayáz SG, Bonilla-Escobar FJ, Fandiño-Losada A, Gutiérrez-Martinez MI. Perceptions about implementation of a Narrative Community-based Group Therapy for Afro-Colombians victims of Violence. Cien Saude Colet. 2017 Sep;22(9): — View Citation
Pacichana-Quinayáz SG, Osorio-Cuéllar GV, Bonilla-Escobar FJ, Fandiño-Losada A, Gutiérrez-Martínez MI. Common Elements Treatment Approach based on a Cognitive Behavioral Intervention: implementation in the Colombian Pacific. Cien Saude Colet. 2016 Jun;21( — View Citation
Pacichana-Quinayaz SG, Osorio-Cuellar GV, Gonzalez S, Bonilla-Escobar FJ, Gutierrez-Martinez MI. Relevance of Qualitative Research Approach in Evaluating Mental Health Interventions among Victims of Violence. International Journal of Medica Students. 2015
Santaella-Tenorio J, Bonilla-Escobar FJ, Nieto-Gil L, Fandiño-Losada A, Gutiérrez-Martínez MI, Bass J, Bolton P. Mental Health and Psychosocial Problems and Needs of Violence Survivors in the Colombian Pacific Coast: A Qualitative Study in Buenaventura an — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. | Symptoms, ranging from 0 for "never" to 3 for "all the time" being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire. Constructs of depression (n=15 symptoms), anxiety (n=10 symptoms), and post-traumatic stress symptoms (n=16 symptoms) were extracted and analyzed out of the mentioned surveys. Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ). For each scale, the mean was calculated in order to use it as the measure for comparisons. Mean difference in scores of symptoms of anxiety, depression, and post-traumatic stress disorders between the subject's baseline and the final assessments were calculated. |
Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment. | |
Secondary | Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction | TMHS scale of 64 items, ranging from 0 for "never" to 3 for "all the time" being the option three the worst condition, including locally relevant symptoms and sub-scales of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (PTSS) (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ). The Dysfunction measure was a gender-specific questionnaire with 12-items for females and 10-items for males. Each item assessed a task ranging from 0 for "no difficulty" to 4 for "cannot do it", being option four the worst condition. For each scale, the mean was calculated in order to use it as the measure for comparisons. Mean difference in scores of TMHS and Dysfunction between the subject's baseline and the final assessments were calculated. |
Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment. |
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