Trial Outcomes & Findings for Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia. (NCT NCT01856673)

Last Updated: 2021-04-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

521 participants

Primary outcome 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.

Results posted on

2021-04-20

Participant Flow

Initial recruitment was done using referrals from key informants, community leaders, who were able to identify people affected by violence. To get more participants a snowball technique was used, participants were asked to refer others with similar problems. The identification numbers on the surveys were then randomized to one of the three arms.

710 people were assessed for eligibility, 189 people were excluded: 175 for not meeting the inclusion criteria, 11 for meeting the exclusion criteria, and 3 refused to participate.

Participant milestones

Participant milestones
Measure	ARM 1: Common Elements Treatment Approach Common Elements Treatment Approach (CETA) only Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and 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.	ARM 2: Narrative Community Group Therapy Narrative Community Group Therapy (NCGT) only Community Therapy Intervention: 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.	ARM 3: Standby Group Standby group without intervention, but under monthly monitoring. Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then 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.
Overall Study STARTED	175	175	171
Overall Study Buenaventura Participants	92	89	88
Overall Study Quibdó Participants	83	86	83
Overall Study COMPLETED	80	90	137
Overall Study NOT COMPLETED	95	85	34

Reasons for withdrawal

Reasons for withdrawal
Measure	ARM 1: Common Elements Treatment Approach Common Elements Treatment Approach (CETA) only Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and 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.	ARM 2: Narrative Community Group Therapy Narrative Community Group Therapy (NCGT) only Community Therapy Intervention: 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.	ARM 3: Standby Group Standby group without intervention, but under monthly monitoring. Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then 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.
Overall Study Withdrawal by Subject	44	50	33
Overall Study Lost to Follow-up	31	34	0
Overall Study Unknown reasons	9	0	0
Overall Study Psychologist decision	1	0	0
Overall Study Paperwork errors	8	0	0
Overall Study Death	1	1	0
Overall Study Protocol Violation	1	0	1

Baseline Characteristics

Each row represents the studied population per city

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 1: Common Elements Treatment Approach n=175 Participants Common Elements Treatment Approach (CETA) only Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and 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 Mental Health Community Workers (MHCW), 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.	ARM 2: Community Group Therapy n=175 Participants Community Group Therapy (CGT) only Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW 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. MHCW 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 MHCW. Finally, session closes with a motivating activity.	ARM 3: Standby Group n=171 Participants Standby group without intervention, but under monthly monitoring. Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then 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.	Total n=521 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=175 Participants	0 Participants n=175 Participants	0 Participants n=171 Participants	0 Participants n=521 Participants
Age, Categorical Between 18 and 65 years	153 Participants n=175 Participants	157 Participants n=175 Participants	149 Participants n=171 Participants	459 Participants n=521 Participants
Age, Categorical >=65 years	22 Participants n=175 Participants	18 Participants n=175 Participants	22 Participants n=171 Participants	62 Participants n=521 Participants
Age, Continuous Buenaventura	40.4 years STANDARD_DEVIATION 14.1 • n=92 Participants • Each row represents the studied population per city	39.5 years STANDARD_DEVIATION 13.3 • n=89 Participants • Each row represents the studied population per city	41.8 years STANDARD_DEVIATION 14.8 • n=88 Participants • Each row represents the studied population per city	40.54 years STANDARD_DEVIATION 14.08 • n=269 Participants • Each row represents the studied population per city
Age, Continuous Quibdó	46 years STANDARD_DEVIATION 19 • n=83 Participants • Each row represents the studied population per city	45.3 years STANDARD_DEVIATION 29.5 • n=86 Participants • Each row represents the studied population per city	44.3 years STANDARD_DEVIATION 18.9 • n=83 Participants • Each row represents the studied population per city	45.39 years STANDARD_DEVIATION 19.09 • n=252 Participants • Each row represents the studied population per city
Sex: Female, Male Female	149 Participants n=175 Participants	157 Participants n=175 Participants	150 Participants n=171 Participants	456 Participants n=521 Participants
Sex: Female, Male Male	26 Participants n=175 Participants	18 Participants n=175 Participants	21 Participants n=171 Participants	65 Participants n=521 Participants
Region of Enrollment Colombia	175 participants n=175 Participants	175 participants n=175 Participants	171 participants n=171 Participants	521 participants n=521 Participants

PRIMARY outcome

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.

Population: Each row represents participants per city

Outcome measures

Outcome measures
Measure	ARM 1: Common Elements Treatment Approach n=175 Participants Common Elements Treatment Approach (CETA) only Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and 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.	ARM 2: Narrative Community Group Therapy n=175 Participants Narrative Community Group Therapy (NCGT) only Narrative Community Therapy Intervention: 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.	ARM 3: Standby Group n=171 Participants Standby group without intervention, but under monthly monitoring. Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then 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.
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Buenaventura- Depression	-0.79 units on a scale Interval -0.92 to -0.65	-0.42 units on a scale Interval -0.55 to -0.29	-0.18 units on a scale Interval -0.32 to -0.04
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Quibdó- Anxiety	-0.63 units on a scale Interval -0.81 to -0.45	-0.51 units on a scale Interval -0.67 to -0.35	-0.50 units on a scale Interval -0.67 to -0.33
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Buenaventura- Post Traumatic Stress	-0.88 units on a scale Interval -1.02 to -0.73	-0.48 units on a scale Interval -0.61 to -0.35	-0.42 units on a scale Interval -0.55 to -0.29
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Quibdó- Post Traumatic Stress	-0.59 units on a scale Interval -0.74 to -0.44	-0.29 units on a scale Interval -0.44 to -0.15	-0.40 units on a scale Interval -0.55 to -0.25
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Quibdó- Depression	-0.48 units on a scale Interval -0.62 to -0.35	-0.40 units on a scale Interval -0.53 to -0.28	-0.34 units on a scale Interval -0.47 to -0.21
Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. Buenaventura- Anxiety	-0.89 units on a scale Interval -1.06 to -0.71	-0.48 units on a scale Interval -0.67 to -0.28	-0.26 units on a scale Interval -0.43 to -0.09

SECONDARY outcome

Population: Each row represents participants per city

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.

Outcome measures

Outcome measures
Measure	ARM 1: Common Elements Treatment Approach n=175 Participants Common Elements Treatment Approach (CETA) only Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and 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.	ARM 2: Narrative Community Group Therapy n=175 Participants Narrative Community Group Therapy (NCGT) only Narrative Community Therapy Intervention: 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.	ARM 3: Standby Group n=171 Participants Standby group without intervention, but under monthly monitoring. Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then 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.
Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction Buenaventura- Total Mental Health Symptoms	-0.74 units on a scale Interval -0.85 to -0.63	-0.39 units on a scale Interval -0.5 to -0.29	-0.28 units on a scale Interval -0.38 to -0.18
Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction Quibdó- Total Mental Health Symptoms	-0.49 units on a scale Interval -0.6 to -0.39	-0.35 units on a scale Interval -0.46 to -0.23	-0.38 units on a scale Interval -0.49 to -0.26
Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction Buenaventura- Dysfunction	-0.41 units on a scale Interval -0.56 to -0.26	-0.31 units on a scale Interval -0.5 to -0.14	-0.01 units on a scale Interval -0.18 to 0.15
Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction Quibdó- Dysfunction	-0.08 units on a scale Interval -0.26 to 0.1	-0.29 units on a scale Interval -0.46 to -0.11	0.002 units on a scale Interval -0.18 to 0.18

Adverse Events

ARM 1: Common Elements Treatment Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

ARM 2: Community Group Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

ARM 3: Standby Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Isabel Gutierrez

CISALVA, Universidad del Valle

Phone: +57-2-5577206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place