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

NCT ID: NCT06073964

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Domestic Violence Psychological Distress Post-Traumatic Stress Disorder Suicidality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TRUST Intervention group

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'.

Group Type EXPERIMENTAL

Trauma Resilience & Understanding Self-help Therapy

Intervention Type BEHAVIORAL

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

Control group

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'.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trauma Resilience & Understanding Self-help Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Research Council (WOTRO Impact and Innovation Grants-2020), The Netherlands

UNKNOWN

Sponsor Role collaborator

Leiden University

OTHER

Sponsor Role collaborator

Globalization Accessibility Innovation and Care Research Collaborative Network

UNKNOWN

Sponsor Role collaborator

Kampala International University

OTHER

Sponsor Role lead

Responsible Party

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Jimmy Ben Forry

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jimmy B Forry, MMed Psych

Role: PRINCIPAL_INVESTIGATOR

Kampala International University

Locations

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Kampala International University

Bushenyi, Southwestern, Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type RESULT

Related Links

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Other Identifiers

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KIU-2022-173

Identifier Type: -

Identifier Source: org_study_id

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