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N/A Completed N=521 Randomized Single-blind Prevention

Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia.

Source: ClinicalTrials.gov NCT01856673 ↗
Enrolled (actual)
521
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. — -0.79; -0.42; -0.18; -0.48 units on a scale

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.
-0.79; -0.42; -0.18; -0.48; -0.40; -0.34 —
SECONDARY
Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction
-0.74; -0.39; -0.28; -0.49; -0.35; -0.38 —

Eligibility Criteria

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01856673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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