Post-Traumatic Stress DisorderACOPLENCT01856673
Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia.
A study testing Common Elements Treatment Approach, Narrative Community Group Therapy and Standby group in people with Post-Traumatic Stress Disorder and Depression, run by Universidad del Valle, Colombia at 2 sites in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depression, Anxiety
- What is being tested?
- Common Elements Treatment Approach, Narrative Community Group Therapy and Standby group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 2 sitesColombia
- Study dates
- Jun 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Centro ACOPLE de Buenaventura
Buenaventura, Valle del Cauca Department
Centro ACOPLE de Quibdó
Quibdó, Departamento del Chocó
About this study
Official title: Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
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.
Read more
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anxiety, Violence
- Being tested
- Common Elements Treatment Approach, Narrative Community Group Therapy, Standby group
- Keywords
- Mental Health, Displacement, Torture, Violence, Post-Traumatic Stress Disorder, Depression, Anxiety, Community-based intervention, Prevention trial, Disabled Persons
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements Treatment ApproachBehavioural
Also called CETA
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.
Narrative Community Group TherapyBehavioural
Also called NCGT
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.
Standby groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: Component-Based Intervention | Experimental | Common Elements Treatment Approach (CETA) only Receives: Behavioral: Common Elements Treatment Approach |
| ARM 2: Community Group Therapy | Experimental | Narrative Community Group Therapy (NCGT) only Receives: Behavioral: Narrative Community Group Therapy |
| ARM 3: Standby group | Other | Standby group without intervention, but under monthly monitoring. Receives: Other: Standby group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Heartland Alliance, United States Agency for International Development (USAID), Johns Hopkins Bloomberg School of Public Health, Afrocolombian Displaced Association - AFRODES
- Responsible party
- Principal investigator, Maria Isabel Gutiérrez Martínez, Universidad del Valle, Colombia
- Investigators
- María Isabel Gutiérrez Martínez, MD, MSc, PhD, Study director, CISALVA Institute of Universidad del Valle, ColombiaAndrés Fandiño Losada, MD, MSc, PhD, Principal investigator, CISALVA Institute of Universidad del Valle, ColombiaFrancisco Javier Bonilla Escobar, MD, MSc, Principal investigator, CISALVA Institute of Universidad del Valle, ColombiaDiana Milena Martínez Buitrago, MD, MSc, Principal investigator, CISALVA Institute of Universidad del Valle, ColombiaJulián Santaella, VMD, MSc, Principal investigator, CISALVA Institute of Universidad del Valle, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856673
- Sponsor's protocol ID
- HA-UV-JHU-2013-001
- Other IDs
- U1111-1138-4894
- Acronym
- ACOPLE
- Status last verified
- Mar 2021
- First submitted
- 14 May 2013
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19774300Bisson 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.
PubMed 17636720Kinzie 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.
PubMed 11824215Murray 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.
PubMed 28316559Osorio-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.
PubMed 28954155Pacichana-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.
PubMed 27276543Bonilla-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.
PubMed 28954156Bonilla-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.
PubMed 30532155Bonilla-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
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
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.
PubMed 30047356Bonilla-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.
PubMed 36815261Bonilla-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.
PubMed 34225496
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
- ClinicalTrials.gov ID
- NCT01856673
- Acronym / sponsor ID
- ACOPLE / HA-UV-JHU-2013-001
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anxiety, Violence
- Keywords
- Mental Health, Displacement, Torture, Violence, Post-Traumatic Stress Disorder, Depression, Anxiety, Community-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Collaborators
- Heartland Alliance, United States Agency for International Development (USAID), Johns Hopkins Bloomberg School of Public Health, Afrocolombian Displaced Association - AFRODES
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Posted 28 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1: Component-Based Intervention | Experimental | Behavioral: Common Elements Treatment ApproachCommon Elements Treatment Approach (CETA) only |
| ARM 2: Community Group Therapy | Experimental | Behavioral: Narrative Community Group TherapyNarrative Community Group Therapy (NCGT) only |
| ARM 3: Standby group | Other | Other: Standby groupStandby group without intervention, but under monthly monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common Elements Treatment ApproachAlso: CETAIt 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. | Behavioural | ARM 1: Component-Based Intervention |
| Narrative Community Group TherapyAlso: NCGTIt 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. | Behavioural | ARM 2: Community Group Therapy |
| Standby groupStandby 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. | Other | ARM 3: Standby group |
Primary outcome
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. 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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19774300Sjolund BH, Kastrup M, Montgomery E, Persson AL. Rehabilitating torture survivors. J Rehabil Med. 2009 Sep;41(9):689-96. doi: 10.2340/16501977-0426.
- Background: PubMed 17636720Bisson 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.
- Background: PubMed 11824215Kinzie 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.
- Results publication: PubMed 28316559Murray 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.
- Results publication: PubMed 28954155Osorio-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.
- Results publication: PubMed 27276543Pacichana-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.
- Results publication: PubMed 28954156Bonilla-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.
- Results publication: PubMed 30532155Bonilla-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.
- Results publicationBonilla-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
- Results publicationPacichana-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
- Results publication: PubMed 30047356Santaella-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.
- Derived from this study: PubMed 36815261Bonilla-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Isabel Gutiérrez Martínez, MD, MSc, PhD study director
CISALVA Institute of Universidad del Valle, Colombia
Andrés Fandiño Losada, MD, MSc, PhD principal investigator
CISALVA Institute of Universidad del Valle, Colombia
Francisco Javier Bonilla Escobar, MD, MSc principal investigator
CISALVA Institute of Universidad del Valle, Colombia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Treatment Approach, Narrative Community Group Therapy and Standby group in people with Post-Traumatic Stress Disorder and Depression, run by Universidad del Valle, Colombia at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856673, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.