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GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda (GBV)

Primary Purpose

Domestic Violence, Psychological Distress, Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Trauma Resilience & Understanding Self-help Therapy
Sponsored by
Kampala International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Domestic Violence focused on measuring formerly Internally Displaced Persons, Gender Based Violence, Trauma Resilience & Understanding Self-help Therapy, Uganda

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All formerly Internally Displaced Persons who will be 18 years or older and who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda at the time of data collection. All formerly Internally Displaced Persons who will be residing in Agweng and Ogur sub-counties at the time of data collection and who previously participated in the study that culminated in the development of the TRUST intervention in Lira district, northern Uganda. All formerly Internally Displaced Persons who will be residing in Agweng, Barr and Ogur sub-counties in Lira district, northern Uganda at the time of data collection and who will screen positive for domestic violence, psychological distress and PTSD. Exclusion Criteria: All formerly Internally Displaced Persons who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda and who will have clinically significant or overt baseline signs and symptoms of physical illnesses or other psychiatric disorders which are unrelated to primary trauma or domestic violence. All formerly Internally Displaced Persons who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda at the time of data collection and who will have significantly severe hearing and speech impediments.

Sites / Locations

  • Kampala International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TRUST Intervention group

Control group

Arm Description

Formerly Internally Displaced Persons living in Lira district, northern Uganda afflicted with primary trauma and experiencing domestic violence will be trained in the community-based utilization of the 'Trauma Resilience & Understanding Self-help Therapy'.

Age and gender cross-matched formerly Internally Displaced Persons living in Lira district, northern Uganda afflicted with primary trauma and experiencing domestic violence will not be trained in the community-based utilization of the 'Trauma Resilience & Understanding Self-help Therapy'.

Outcomes

Primary Outcome Measures

Rate of Domestic Violence Experiences
Change in frequency of experiences assessed using the Assessment Screen to Identify Survivors' Toolkit for Gender Based Violence Scale.
Prevalence of Psychological Distress
Change in severity of symptoms assessed using the Refugee Health Sceener-15 Scale.
Prevalence of Post-Traumatic Stress Disorder
Change in severity of symptoms assessed using the Impact of Events Scale-Shorter Revised Scale & the Mini International Neuropsychiatric Interview guide module H for Post-Traumatic Stress Disorder.
Prevalence of Suicidality Risk
Change in levels of risk assessed using the Mini International Neuropsychiatric Interview guide module B for Suicidality Risk.

Secondary Outcome Measures

Prevalence of Poor Social Economic Resilience Levels
Change in levels of impairment assessed using the Social Economic Resilience Scale-Shorter version.

Full Information

First Posted
September 26, 2023
Last Updated
October 5, 2023
Sponsor
Kampala International University
Collaborators
Dutch Research Council (WOTRO Impact and Innovation Grants-2020), The Netherlands, Leiden University, Globalization Accessibility Innovation and Care Research Collaborative Network
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1. Study Identification

Unique Protocol Identification Number
NCT06073964
Brief Title
GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda
Acronym
GBV
Official Title
Gender Based Violence and the Level of Utilization of the 'Trauma Resilience & Understanding Self-help Therapy' Among Formerly Internally Displaced Persons Living in Lira District, Northern Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kampala International University
Collaborators
Dutch Research Council (WOTRO Impact and Innovation Grants-2020), The Netherlands, Leiden University, Globalization Accessibility Innovation and Care Research Collaborative Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this community-based interventional study was to determine the effectiveness of the 'Trauma Resilience & Understanding Self-help Therapy' (TRUST) in managing domestic violence & primary trauma among formerly Internally Displaced Persons (fIDPs) in northern Uganda. The main questions it aimed to answer were: What was the level of utilization and short-term effects of the TRUST intervention on the experiences of domestic violence and high levels of primary trauma among fIDPs living in northern Uganda who would have been using TRUST within their communities after completing the training in the community-based TRUST utilization? What were the clinical indications of the TRUST intervention and psychological operators among fIDPs living in northern Uganda who would have been using TRUST within their communities to manage their experiences of domestic violence and high levels of primary trauma? Participants found to have experienced domestic violence in the last one year and were having high levels of primary trauma were randomly assigned to the intervention group that was trained in the utilization of the TRUST within their communities and then followed up for 12 weeks (TRUST group). The investigators then compared the results obtained from the TRUST group with those attained from an age and gender cross-matched control group of fIDPs who were not trained in the utilization of the TRUST within their communities (Control group). This was done to see if the community-based utilization of the TRUST intervention changed the levels of primary trauma & experiences of domestic violence among its users (TRUST group) when compared to the non-users (Control group).
Detailed Description
An indigenous rebel outfit waged a decades' civil war in eastern and northern Uganda until the early 2000s. This rebellion resulted in forceful internal displacement of most of the local population leading to unwarranted misery. In the aftermath of this rebellion, the internally displaced returned to their areas of origin. However, a significant proportion of these formerly internally displaced persons (fIDPs) have since then been plagued with a plethora of adversities including high levels of primary trauma, frequent experiences of domestic violence and impaired social economic resilience (SER) levels. A newly developed psychosocial therapeutic intervention called the 'trauma resilience & understanding self-help therapy' (TRUST) was revealed to be qualitatively effective in managing high levels of primary trauma, experiences of domestic violence and poor SER levels among refugees and fIDPs. However, the quantitative effectiveness of TRUST and the psychological operators among the fIDPs and refugees within which it is grounded still remain a scientific mystery. Hence, an appropriate prospective community-based cohort research study was conducted to this effect. The investigators carried out a descriptive community-based prospective study from November 2022 to March 2023 among 284 randomly recruited adults who were fIDPs living in northern Uganda using quantitative data collection techniques in natural experiments conducted via repeated assessments. The resultant data were analyzed using univariate, bivariate and multivariate linear, logistic and Poisson regression as well as determining the effect sizes of the community-based utilization of TRUST on the high levels of primary trauma, experiences of domestic violence and poor SER levels among fIDPs living in northern Uganda. These findings were compared with those obtained among a randomly selected control group of fIDPs living in northern Uganda who were cross-matched according to their age and gender, were experiencing high levels of primary trauma and domestic violence as well as poor SER levels and had not been trained in the community-based utilization of TRUST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Domestic Violence, Psychological Distress, Post-Traumatic Stress Disorder, Suicidality
Keywords
formerly Internally Displaced Persons, Gender Based Violence, Trauma Resilience & Understanding Self-help Therapy, Uganda

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRUST Intervention group
Arm Type
Experimental
Arm Description
Formerly Internally Displaced Persons living in Lira district, northern Uganda afflicted with primary trauma and experiencing domestic violence will be trained in the community-based utilization of the 'Trauma Resilience & Understanding Self-help Therapy'.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Age and gender cross-matched formerly Internally Displaced Persons living in Lira district, northern Uganda afflicted with primary trauma and experiencing domestic violence will not be trained in the community-based utilization of the 'Trauma Resilience & Understanding Self-help Therapy'.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Resilience & Understanding Self-help Therapy
Intervention Description
A self-help psychosocial therapeutic intervention requiring one to undergo a basic training in its community-based utilization.
Primary Outcome Measure Information:
Title
Rate of Domestic Violence Experiences
Description
Change in frequency of experiences assessed using the Assessment Screen to Identify Survivors' Toolkit for Gender Based Violence Scale.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)
Title
Prevalence of Psychological Distress
Description
Change in severity of symptoms assessed using the Refugee Health Sceener-15 Scale.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)
Title
Prevalence of Post-Traumatic Stress Disorder
Description
Change in severity of symptoms assessed using the Impact of Events Scale-Shorter Revised Scale & the Mini International Neuropsychiatric Interview guide module H for Post-Traumatic Stress Disorder.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)
Title
Prevalence of Suicidality Risk
Description
Change in levels of risk assessed using the Mini International Neuropsychiatric Interview guide module B for Suicidality Risk.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)
Secondary Outcome Measure Information:
Title
Prevalence of Poor Social Economic Resilience Levels
Description
Change in levels of impairment assessed using the Social Economic Resilience Scale-Shorter version.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)
Other Pre-specified Outcome Measures:
Title
Percentage of Participants with impaired Psychological Indicators
Description
Changes in mental state examination findings assessed via a comprehensive clinical neuropyschiatric evaluation.
Time Frame
Pilot Study, Baseline/Pre-TRUST Training (After 1 month from the pilot study), Post-TRUST Training (After 6 weeks) & Post-TRUST Utilization (After 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All formerly Internally Displaced Persons who will be 18 years or older and who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda at the time of data collection. All formerly Internally Displaced Persons who will be residing in Agweng and Ogur sub-counties at the time of data collection and who previously participated in the study that culminated in the development of the TRUST intervention in Lira district, northern Uganda. All formerly Internally Displaced Persons who will be residing in Agweng, Barr and Ogur sub-counties in Lira district, northern Uganda at the time of data collection and who will screen positive for domestic violence, psychological distress and PTSD. Exclusion Criteria: All formerly Internally Displaced Persons who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda and who will have clinically significant or overt baseline signs and symptoms of physical illnesses or other psychiatric disorders which are unrelated to primary trauma or domestic violence. All formerly Internally Displaced Persons who will be residing in the sub-counties of Agweng, Barr and Ogur in Lira district, northern Uganda at the time of data collection and who will have significantly severe hearing and speech impediments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy B Forry, MMed Psych
Organizational Affiliation
Kampala International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kampala International University
City
Bushenyi
State/Province
Southwestern
ZIP/Postal Code
71
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is due to the sensitive nature of the data and their legal implications.
Citations:
Citation
Forry, J. B., Kirabira, J., Akimana, B., Nakawuki, M., Gumisiriza, N., Ssebuufu, R., & Ashaba, S. (2022). Gender-based violence and its determinants during the COVID-19 lockdown in a low-income country: a cross-sectional survey. Journal of gender-based violence, 1-19.
Results Reference
result
Links:
URL
https://bristoluniversitypressdigital.com/view/journals/jgbv/aop/article-10.1332-239868021X16460622083652/article-10.1332-239868021X16460622083652.xml
Description
Background Peer-reviewed Published Article

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GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda

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