An interventional study of Trauma Resilience & Understanding Self-help Therapy in Domestic Violence, Psychological Distress and Post-Traumatic Stress Disorder, sponsored by Kampala International University. Completed at 1 site in Uganda. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Kampala International University · Not applicable, Interventional, and Other
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:
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).
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 284 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →This is the only study on the registry with Kampala International University as lead sponsor.
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Exclusion Criteria:
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
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'.
A self-help psychosocial therapeutic intervention requiring one to undergo a basic training in its community-based utilization.
Rate of Domestic Violence Experiences
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)
Prevalence of Psychological Distress
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)
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.
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)
Prevalence of Suicidality Risk
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)
Prevalence of Poor Social Economic Resilience Levels
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)
Percentage of Participants with impaired Psychological Indicators
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)
Plan to share: No — This is due to the sensitive nature of the data and their legal implications.
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