NCT06073964

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

September 26, 2023

Last Update Submit

October 5, 2023

Conditions

Keywords

formerly Internally Displaced PersonsGender Based ViolenceTrauma Resilience & Understanding Self-help TherapyUganda

Outcome Measures

Primary Outcomes (4)

  • Rate of Domestic Violence Experiences

    Change in frequency of experiences assessed using the Assessment Screen to Identify Survivors' Toolkit for Gender Based Violence Scale.

    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)

  • Prevalence of Psychological Distress

    Change in severity of symptoms assessed using the Refugee Health Sceener-15 Scale.

    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)

  • 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.

    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)

  • Prevalence of Suicidality Risk

    Change in levels of risk assessed using the Mini International Neuropsychiatric Interview guide module B for Suicidality Risk.

    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 Outcomes (1)

  • Prevalence of Poor Social Economic Resilience Levels

    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 Outcomes (1)

  • Percentage of Participants with impaired Psychological Indicators

    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)

Study Arms (2)

TRUST Intervention group

EXPERIMENTAL

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'.

Behavioral: Trauma Resilience & Understanding Self-help Therapy

Control group

NO INTERVENTION

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'.

Interventions

A self-help psychosocial therapeutic intervention requiring one to undergo a basic training in its community-based utilization.

TRUST Intervention group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kampala International University

Bushenyi, Southwestern, 71, Uganda

Location

Related Publications (1)

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSuicidal Ideation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jimmy B Forry, MMed Psych

    Kampala International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 10, 2023

Study Start

November 23, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

This is due to the sensitive nature of the data and their legal implications.

Locations