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

NCT01856673 | Completed Results DMC

• 2 other identifiers: HA-UV-JHU-2013-001U1111-1138-4894
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction

  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.

Study Arms (3)

ARM 1: Component-Based Intervention

EXPERIMENTAL

Common Elements Treatment Approach (CETA) only

Behavioral: Common Elements Treatment Approach

ARM 2: Community Group Therapy

EXPERIMENTAL

Narrative Community Group Therapy (NCGT) only

Behavioral: Narrative Community Group Therapy

ARM 3: Standby group

OTHER

Standby group without intervention, but under monthly monitoring.

Other: Standby group

Interventions

Common Elements Treatment Approach BEHAVIORAL

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.

Also known as: CETA

ARM 1: Component-Based Intervention

Narrative Community Group Therapy BEHAVIORAL

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.

Also known as: NCGT

ARM 2: Community Group Therapy

Standby group OTHER

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.

ARM 3: Standby group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead
• Heartland Alliance: collaborator
• United States Agency for International Development (USAID): collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Afrocolombian Displaced Association - AFRODES: collaborator

Study Sites (2)

Centro ACOPLE de Quibdó

Quibdó, Departamento del Chocó, Colombia

Location

Centro ACOPLE de Buenaventura

Buenaventura, Valle del Cauca Department, Colombia

Location

Related Publications (13)

• Sjolund BH, Kastrup M, Montgomery E, Persson AL. Rehabilitating torture survivors. J Rehabil Med. 2009 Sep;41(9):689-96. doi: 10.2340/16501977-0426.

  PMID: 19774300 BACKGROUND

• Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.

  PMID: 17636720 BACKGROUND

• Kinzie JD. Psychotherapy for massively traumatized refugees: the therapist variable. Am J Psychother. 2001;55(4):475-90. doi: 10.1176/appi.psychotherapy.2001.55.4.475.

  PMID: 11824215 BACKGROUND

• 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 Dec;12(Suppl 1):94-112. doi: 10.1097/WTF.0000000000000070.

  PMID: 28316559 RESULT

• Osorio-Cuellar GV, Pacichana-Quinayaz SG, Bonilla-Escobar FJ, Fandino-Losada A, Gutierrez-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):3045-3052. doi: 10.1590/1413-81232017229.00402016.

  PMID: 28954155 RESULT

• Pacichana-Quinayaz SG, Osorio-Cuellar GV, Bonilla-Escobar FJ, Fandino-Losada A, Gutierrez-Martinez MI. Common Elements Treatment Approach based on a Cognitive Behavioral Intervention: implementation in the Colombian Pacific. Cien Saude Colet. 2016 Jun;21(6):1947-56. doi: 10.1590/1413-81232015216.07062015.

  PMID: 27276543 RESULT

• Bonilla-Escobar FJ, Osorio-Cuellar GV, Pacichana-Quinayaz SG, Sanchez-Renteria G, Fandino-Losada A, Gutierrez MI. Do not forget culture when implementing mental health interventions for violence survivors. Cien Saude Colet. 2017 Sep;22(9):3053-3059. doi: 10.1590/1413-81232017229.12982016.

  PMID: 28954156 RESULT

• Bonilla-Escobar FJ, Fandino-Losada A, Martinez-Buitrago DM, Santaella-Tenorio J, Tobon-Garcia D, Munoz-Morales EJ, Escobar-Roldan ID, Babcock L, Duarte-Davidson E, Bass JK, Murray LK, Dorsey S, Gutierrez-Martinez MI, Bolton P. A randomized controlled trial of a transdiagnostic cognitive-behavioral intervention for Afro-descendants' survivors of systemic violence in Colombia. PLoS One. 2018 Dec 10;13(12):e0208483. doi: 10.1371/journal.pone.0208483. eCollection 2018.

  PMID: 30532155 RESULT

• Bonilla-Escobar FJ, Lim HM. A Call for Action for Mental Health: Medical Students and Physicians' roles. International Journal of Medical Students. 2015;3(3):121-122. https://doi.org/10.5195/ijms.2015.131

  RESULT

• 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;3(3):170-171. https://doi.org/10.5195/ijms.2015.194

  RESULT

• Santaella-Tenorio J, Bonilla-Escobar FJ, Nieto-Gil L, Fandino-Losada A, Gutierrez-Martinez 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 and Quibdo. Prehosp Disaster Med. 2018 Dec;33(6):567-574. doi: 10.1017/S1049023X18000523. Epub 2018 Jul 26.

  PMID: 30047356 RESULT

• Bonilla-Escobar FJ, Fandino-Losada A, Martinez-Buitrago DM, Santaella-Tenorio J, Escobar-Roldan I, Tobon-Garcia D, Munoz-Morales EJ, Babcock L, Duarte-Davidson E, Murray LK, Gutierrez-Martinez MI. Mental health Narrative Community-Based Group Therapy in violence-displaced Afro-Colombians: a randomized controlled trial. Med Confl Surviv. 2023 Mar;39(1):28-47. doi: 10.1080/13623699.2023.2177951. Epub 2023 Feb 23.

  PMID: 36815261 DERIVED

• Bonilla-Escobar FJ, Osorio-Cuellar GV, Pacichana-Quinayaz SG, Rangel-Gomez AN, Gomes-Pereira LD, Fandino-Losada A, Gutierrez-Martinez MI. Impacts of violence on the mental health of Afro-descendant survivors in Colombia. Med Confl Surviv. 2021 Jun;37(2):124-145. doi: 10.1080/13623699.2021.1938035. Epub 2021 Jul 5.

  PMID: 34225496 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Limitations and Caveats

This study will include a subsequent follow-up to assess middle-term effects of the interventions. The proportion of participants lost to follow-up represents a limitation. The low male participation in the study did not allow for a gender subgroup.

Results Point of Contact

• Title: Maria Isabel Gutierrez
• Organization: CISALVA, Universidad del Valle

maria.gutierrez@correounivalle.edu.co

+57-2-5577206

Study Officials

• María Isabel Gutiérrez Martínez, MD, MSc, PhD

  CISALVA Institute of Universidad del Valle, Colombia

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 20, 2021
• Results First Posted: September 28, 2015

Record last verified: 2021-03

Locations

CO (2)