Clinical trial NCT01856673: Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia.
Official title: Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Depression
Anxiety
Violence
Keywords: Mental Health
Displacement
Torture
Violence
Post-Traumatic Stress Disorder
Depression
Anxiety
Community-based intervention
Prevention trial
Disabled Persons
Lead sponsor: Universidad del Valle, Colombia
Sponsor class: OTHER
Collaborators: name: Heartland Alliance
name: United States Agency for International Development (USAID)
name: Johns Hopkins Bloomberg School of Public Health
name: Afrocolombian Displaced Association - AFRODES
First posted: 2013-05-17
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Colombian armed conflict predominantly affects rural communities; armed conflict has caused thousands of deaths and the displacement of a vast amount of people from rural areas. A considerable amount of the displacement comes from the two most important cities in Pacific coast region: Buenaventura in Valle del Cauca province and Quibdó in Chocó province.

This project will assess treatments, Common Elements Treatment Approach (CETA) and Narrative Community Group Therapy (NCGT), to reduce mental symptoms triggered by violence and will develop mechanisms for a sustainable supply of mental health services in the region.

Adult Afro-Colombian persons who have responded to the study survey but present symptoms of severe mental illness like schizophrenic, psychotic, suicidal attempters, those who can potentially harm others, or who require specialized treatment will not be included in the study.

They will be referred to a project psychologist who will determine whether they require psychiatric treatment, in which case, they will be referred to health institutions through social workers who will ensure treatment is given. Finally, anyone who is related to the LPCW will be excluded.

For the CETA arm, new clients will be enrolled as long as a treatment position becomes available (i.e., as long as previous clients have completed the treatment) to keep the providers (LPCW) running at full capacity. These new clients will be chosen from those randomly allocated to receive the CETA treatment; within fifteen (15) days of the completion of treatment the participants will be reassessed.

Similarly, the NCGT arm will form new groups as long as place becomes available (i.e, as long as previous group has finished treatment) to keep providers running at full capacity. Group members will be chosen from randomly allocated participant to receive NCGT, selecting enough people each time to fill up a group before the treatment begins. All group members will be reassessed within fifteen (15) days of completing the NCGT.

The participants allocated in the control group will undergo a waiting period similar to the period between the initial and final assessments of those receiving CETA and NCGT. This period is estimated to be 3 months, but it could be longer if there are treatment delays. At the end of this time, the participants will be reassessed.

after the control group is reassessed they will be evaluated and receive professional attention by psychologists to decide what is the best intervention that we can offer to the clients in both cities.

Missing values will be handle using multiple imputation methods and data will be analyzed with an intention to treat basis. Sensitivity analysis will be carried out using non-imputed database and including co-variables in the models the inverse probability weight to lost of follow-up.

The anticipated results is a reduction in anxiety, depression and post-traumatic stress disorder symptoms of 20 points among subjects in intervention groups (CETA or NCGT ) compared with those in the control group.

An adherence of 70% is expected to generate strategies for the promotion and prevention in mental health for Afro-Colombian victims of violence and displacement.

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).

Primary outcomes:
measure: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.
timeFrame: 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 outcomes:
measure: Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction
timeFrame: 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.
Other outcomes:
Locations:
city: Quibdó
country: Colombia
facility: Centro ACOPLE de Quibdó
state: Chocó
city: Buenaventura
country: Colombia
facility: Centro ACOPLE de Buenaventura
state: Valle Del Cauca
Study officials:
affiliation: CISALVA Institute of Universidad del Valle, Colombia
name: María Isabel Gutiérrez Martínez, MD, MSc, PhD
role: STUDY_DIRECTOR
affiliation: CISALVA Institute of Universidad del Valle, Colombia
name: Andrés Fandiño Losada, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CISALVA Institute of Universidad del Valle, Colombia
name: Francisco Javier Bonilla Escobar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CISALVA Institute of Universidad del Valle, Colombia
name: Diana Milena Martínez Buitrago, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CISALVA Institute of Universidad del Valle, Colombia
name: Julián Santaella, VMD, MSc
role: PRINCIPAL_INVESTIGATOR
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