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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856673
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : September 28, 2015
Last Update Posted : February 18, 2016
Sponsor:
Collaborators:
Heartland Alliance
United States Agency for International Development (USAID)
Johns Hopkins Bloomberg School of Public Health
Afrocolombian Displaced Association - AFRODES
Information provided by (Responsible Party):
Maria Isabel Gutiérrez Martínez, Universidad del Valle, Colombia

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.


Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Depression Anxiety Violence Behavioral: Common Elements Treatment Approach Behavioral: Narrative Community Group Therapy Other: Standby group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARM 1: Component-Based Intervention
Common Elements Treatment Approach (CETA) only
Behavioral: Common Elements Treatment Approach
It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among a population victimized by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and a panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team.
Other Name: CETA

Experimental: ARM 2: Community Group Therapy
Narrative Community Group Therapy (NCGT) only
Behavioral: Narrative Community Group Therapy
It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity.
Other Name: NCGT

ARM 3: Standby group
Standby group without intervention, but under monthly monitoring.
Other: Standby group
Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center.




Primary Outcome Measures :
  1. Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. [ Time Frame: 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. ]

    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, from which they were analyzed the constructs of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (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).

    For each scale, the mean was calculated in order to used it as the measure for comparisions.

    Mean difference in scores of symptoms of anxiety, depression and post-traumatic stress disorders between the subject's baseline and the final assessments according to the study instrument.



Secondary Outcome Measures :
  1. Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction [ Time Frame: 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. ]

    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 the option four the worst condition.

    For each scale, the mean was calculated in order to used it as the measure for comparisions.

    Mean difference in scores of TMHS and Dysfunction between the subject's baseline and the final assessments according to the study instrument.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856673


Locations
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Colombia
Centro ACOPLE de Quibdó
Quibdó, Chocó, Colombia
Centro ACOPLE de Buenaventura
Buenaventura, Valle del Cauca, Colombia
Sponsors and Collaborators
Universidad del Valle, Colombia
Heartland Alliance
United States Agency for International Development (USAID)
Johns Hopkins Bloomberg School of Public Health
Afrocolombian Displaced Association - AFRODES
Investigators
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Study Director: María Isabel Gutiérrez Martínez, MD, MSc, PhD CISALVA Institute of Universidad del Valle, Colombia
Principal Investigator: Andrés Fandiño Losada, MD, MSc, PhD CISALVA Institute of Universidad del Valle, Colombia
Principal Investigator: Francisco Javier Bonilla Escobar, MD, MSc CISALVA Institute of Universidad del Valle, Colombia
Principal Investigator: Diana Milena Martínez Buitrago, MD, MSc CISALVA Institute of Universidad del Valle, Colombia
Principal Investigator: Julián Santaella, VMD, MSc CISALVA Institute of Universidad del Valle, Colombia
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Isabel Gutiérrez Martínez, Professor, Universidad del Valle, Colombia
ClinicalTrials.gov Identifier: NCT01856673    
Other Study ID Numbers: HA-UV-JHU-2013-001
U1111-1138-4894 ( Registry Identifier: Universal Trial Number (UTN) )
First Posted: May 17, 2013    Key Record Dates
Results First Posted: September 28, 2015
Last Update Posted: February 18, 2016
Last Verified: January 2016
Keywords provided by Maria Isabel Gutiérrez Martínez, Universidad del Valle, Colombia:
Mental Health
Displacement
Torture
Violence
Post-Traumatic Stress Disorder
Depression
Anxiety
Community-based intervention
Prevention trial
Disabled Persons
Additional relevant MeSH terms:
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Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders