Emotional DisorderNCT03127982
Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia
A study testing Unified Protocol in people with Emotional Disorder, run by University of Los Andes, Columbia at 1 site in Colombia.
Trial summary
The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in victims of the Colombian armed conflict. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2015to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria. Individuals registered as victims in Colombian Victims Unit, 18 years or older, who meet the diagnostic criteria for one or more anxiety disorder(s), depressive disorder(s) or post-traumatic stress and related disorder(s) according to the Diagnostic and Statistical Manual (DSM-5, 2013) as determined by the International Neuro-Psychiatric Interview M.I.N.I.
Who cannot join
- Exclusion criteria. Individuals diagnosed with psychotic disorders, bipolar affective disorders, intellectual disability, dementia, substance abuse (as primary diagnoses, with hospitalization requirement for treatment) as well as individuals who endorse acute suicidal risk. Those that do not meet the inclusion criteria, but are in need of mental health attention, will be referred to entities of the Health System, so that they receive the pertinent treatment.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Laboratorio de Psicología Clínica Uniandes - Universidad de Los Andes
Bogotá, DC
About this study
Official title: Effects of the Adaptation of the Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia: A Randomized Clinical Trial
The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in victims of the Colombian armed conflict.
A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100 internally displaced victims of armed conflict living in Bogotá is being implemented. Participants are recruited from several governmental, non-governmental agencies as well as community organizations of victims. Participants are being randomly assigned to treatment condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly sessions covering the 8 modules of the original UP. The effects of the UP is evaluated through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.
Read the detailed description
Specific objectives
- To translate and adapt the UP, taking into account the cultural, social, economic and political context of individuals exposed to political violence in Colombia.
- Develop and adapt a set of assessment tools to identify victim's symptoms of anxiety, depression, and related disorders.
- Conduct a randomized clinical trial comparing outcomes of 12 biweekly sessions of the culturally adapted UP in a group participants randomized to immediate treatment to a waiting list control receiving delayed (6-week) treatment.
- To identify potential variables that mediate or moderate the effects of treatment with the UP.
Methodology Design. Allocation randomized Participants. 100 individuals presenting emotional sequelae of exposure to violent events of armed conflict in Colombia, 50 of which are being randomly assigned to treatment group and 50 to control group (waiting list).
- Conditions
- Emotional Disorder
- Being tested
- Unified Protocol
- Keywords
- Anxiety Depression Emotion PTSD Randomized Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
Also called UP for the Transdiagnostic Treatment of Emotional Disorders
The Unified Protocol (UP) is a trans-diagnostic cognitive-behavioral therapy (tCBT) for individuals diagnosed with anxiety disorders, depression and related disorders (which we refer to as emotional disorders).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Immediately following randomization, participants in this condition attend 12-13 biweekly face-to face individual sessions that last approximately 1.5 hrs each of the cultural adaptation of the Unified Protocol trans diagnostic treatment comprising the following modules: motivation enhancement, psycho-education of emotion, emotion awareness training, cognitive reappraisal, emotion avoidance and emotion-driven behavior, tolerance training for physical sensations, emotion exposure, and relapse prevention. Treatment is provided by graduate students in clinical psychology who have been trained in the UP and receive weekly supervision by experienced clinicians and use a Workbook for homework assigned between sessions. Receives: Behavioral: Unified Protocol |
| Group 2 | Active comparator | Participants randomly assigned to this condition do not receive any active intervention during a six-week wait period after randomization, while completing assessment evaluation at the beginning and end of wait list period, after which they receive the same intervention (Unified Protocol) provided to the treatment condition (Group 1). Receives: Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.
PHQ - complete.
Measured: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD)
Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
Measured: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Secondary outcomes (4)
Quality of Life. Self-reported measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life satisfaction.
Quality of Life Enjoyment Questionnaire, Q-LES-Q.
Measured: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Anxiety measure.
Overall Anxiety Severity and Impairment Scale (OASIS)
Measured: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Depression measure.
Overall Depression Severity and Impairment Scale. (ODSIS).
Measured: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Current level of functioning.
Current level of functioning measure. Adapted from ACOPLE. (Santaella-Tenorio J, Bonilla- Escobar FJ, Fandiño-Losada A, Bass J, Gutiérrez-Martínez MI, Bolton P. Validating an Instrument for victims of violence in Colombia: Evaluation of Two Community-based Mental Health Interventions for Violence-Displaced Afro-Descendants in Colombia. [Unpublished manuscript]. Colombia: University of Valle, Instituto CISALVA; 2013). -[Time Frame: Baseline, and 3-month follow-up.
Measured: Baseline, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Jan 2015
- Primary completion20 Dec 2020
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Single Blind
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Los Andes, Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonidas Castro Camacho, Ph.D.,ABPP, University of Los Andes, Columbia
- Investigators
- Leonidas Castro-Camacho, Ph.D., Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127982
- Sponsor's protocol ID
- COLCIENCIAS 644-2014
- Status last verified
- Nov 2022
- First submitted
- 7 Apr 2017
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castro-Camacho L, Barlow DH, Garcia N, Farchione TJ, Idrobo F, Rattner M, Quant DM, Gonzalez L, Moreno JD. Effects of a Contextual Adaptation of the Unified Protocol in Multiple Emotional Disorders in Individuals Exposed to Armed Conflict in Colombia: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Oct 1;80(10):991-999. doi: 10.1001/jamapsychiatry.2023.2392.
PubMed 37466983
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Adaptation of the Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03127982
- Acronym / sponsor ID
- COLCIENCIAS 644-2014
- Conditions
- Emotional Disorder
- Keywords
- Anxiety Depression Emotion PTSD Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of Los Andes, ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims at evaluating the effects of a CBT intervention, a cultural adaptation of the Unified Protocol for the Trans-diagnostic Treatment of Emotional Disorders (UP) in victims of the Colombian armed conflict.
A randomized clinical trial aimed at evaluating the effects of the UP in a group of 100 internally displaced victims of armed conflict living in Bogotá is being implemented. Participants are recruited from several governmental, non-governmental agencies as well as community organizations of victims. Participants are being randomly assigned to treatment condition (N=50) or to waiting-list control (N=50). Treatment consists in 12 biweekly sessions covering the 8 modules of the original UP. The effects of the UP is evaluated through Patient Health Questionnaire (PHQ) and several measures of co-morbid emotional disorders, Anxiety, Depression, PTSD as well as level of functioning and quality of life.
Detailed description
Specific objectives
- To translate and adapt the UP, taking into account the cultural, social, economic and political context of individuals exposed to political violence in Colombia.
- Develop and adapt a set of assessment tools to identify victim's symptoms of anxiety, depression, and related disorders.
- Conduct a randomized clinical trial comparing outcomes of 12 biweekly sessions of the culturally adapted UP in a group participants randomized to immediate treatment to a waiting list control receiving delayed (6-week) treatment.
- To identify potential variables that mediate or moderate the effects of treatment with the UP.
Methodology Design. Allocation randomized Participants. 100 individuals presenting emotional sequelae of exposure to violent events of armed conflict in Colombia, 50 of which are being randomly assigned to treatment group and 50 to control group (waiting list).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Single Blind
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Unified ProtocolImmediately following randomization, participants in this condition attend 12-13 biweekly face-to face individual sessions that last approximately 1.5 hrs each of the cultural adaptation of the Unified Protocol trans diagnostic treatment comprising the following modules: motivation enhancement, psycho-education of emotion, emotion awareness training, cognitive reappraisal, emotion avoidance and emotion-driven behavior, tolerance training for physical sensations, emotion exposure, and relapse prevention. Treatment is provided by graduate students in clinical psychology who have been trained in the UP and receive weekly supervision by experienced clinicians and use a Workbook for homework assigned between sessions. |
| Group 2 | Active comparator | Behavioral: Unified ProtocolParticipants randomly assigned to this condition do not receive any active intervention during a six-week wait period after randomization, while completing assessment evaluation at the beginning and end of wait list period, after which they receive the same intervention (Unified Protocol) provided to the treatment condition (Group 1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria. Individuals registered as victims in Colombian Victims Unit, 18 years or older, who meet the diagnostic criteria for one or more anxiety disorder(s), depressive disorder(s) or post-traumatic stress and related disorder(s) according to the Diagnostic and Statistical Manual (DSM-5, 2013) as determined by the International Neuro-Psychiatric Interview M.I.N.I.
Key exclusion criteria (1 listed)
- Exclusion criteria. Individuals diagnosed with psychotic disorders, bipolar affective disorders, intellectual disability, dementia, substance abuse (as primary diagnoses, with hospitalization requirement for treatment) as well as individuals who endorse acute suicidal risk. Those that do not meet the inclusion criteria, but are in need of mental health attention, will be referred to entities of the Health System, so that they receive the pertinent treatment.
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 |
|---|---|---|
| Unified ProtocolAlso: UP for the Transdiagnostic Treatment of Emotional DisordersThe Unified Protocol (UP) is a trans-diagnostic cognitive-behavioral therapy (tCBT) for individuals diagnosed with anxiety disorders, depression and related disorders (which we refer to as emotional disorders). | Behavioural | Group 1, Group 2 |
Primary outcome
Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire.
Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
PHQ - complete.
Change in symptoms of post-traumatic stress as measured by the Post-Traumatic Stress Disorder (PTSD)
Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5).
4 secondary outcomes
Quality of Life. Self-reported measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life satisfaction.
Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Anxiety measure.
Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Depression measure.
Time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.
Current level of functioning.
Time frame: Baseline, and 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Derived from this study: PubMed 37466983Castro-Camacho L, Barlow DH, Garcia N, Farchione TJ, Idrobo F, Rattner M, Quant DM, Gonzalez L, Moreno JD. Effects of a Contextual Adaptation of the Unified Protocol in Multiple Emotional Disorders in Individuals Exposed to Armed Conflict in Colombia: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Oct 1;80(10):991-999. doi: 10.1001/jamapsychiatry.2023.2392.
- Individual participant dataSharing planned: No
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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.
Leonidas Castro-Camacho, Ph.D. principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Emotional Disorder, run by University of Los Andes, Columbia at 1 site 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 1 inclusion and 1 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 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in diagnostic criteria for depression, anxiety, as assessed by the Patient Health Questionnaire. (time frame: Administered at baseline, post-treatment - on average 8 weeks after the beginning of treatment, and a 3-month follow-up.). The study lists 2 primary outcomes in all. 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 NCT03127982, which also lists 1 linked publication.
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 18 Nov 2022.