|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 November 2022 |
|
Main ID: |
NCT03127982 |
|
Date of registration:
|
07/04/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia
|
|
Scientific title:
|
Effects of the Adaptation of the Unified Protocol for Emotional Problems in Victims of the Armed Conflict in Colombia: A Randomized Clinical Trial |
|
Date of first enrolment:
|
January 1, 2015 |
|
Target sample size:
|
109 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03127982 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Colombia
| | | | | | | |
|
Contacts
|
|
Name:
|
Leonidas Castro-Camacho, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Universidad de los Andes |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Emotional Disorder
|
|
Intervention(s)
|
|
Behavioral: Unified Protocol
|
|
Primary Outcome(s)
|
|
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.]
|
|
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.]
|
|
Secondary Outcome(s)
|
|
Current level of functioning.
[Time Frame: Baseline, and 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.]
|
|
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.]
|
|
Secondary ID(s)
|
|
COLCIENCIAS 644-2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|