Domestic ViolenceGBVNCT06073964
GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda
A study testing Trauma Resilience & Understanding Self-help Therapy in people with Domestic Violence and Psychological Distress, run by Kampala International University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Domestic Violence, Psychological Distress, Post-Traumatic Stress Disorder
- What is being tested?
- Trauma Resilience & Understanding Self-help Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUganda
- Study dates
- 23 Nov 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Trauma Resilience & Understanding Self-help Therapy
- Keywords
- formerly Internally Displaced Persons, Gender Based Violence, Trauma Resilience & Understanding Self-help Therapy, Uganda
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Resilience & Understanding Self-help TherapyBehavioural
A self-help psychosocial therapeutic intervention requiring one to undergo a basic training in its community-based utilization.
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: 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'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Domestic Violence Experiences
Change in frequency of experiences assessed using the Assessment Screen to Identify Survivors' Toolkit for Gender Based Violence Scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Change in levels of impairment assessed using the Social Economic Resilience Scale-Shorter version.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start23 Nov 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kampala International University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Research Council (WOTRO Impact and Innovation Grants-2020), The Netherlands, Leiden University, Globalization Accessibility Innovation and Care Research Collaborative Network
- Responsible party
- Principal investigator, Jimmy Ben Forry, Kampala International University
- Investigators
- Jimmy B Forry, MMed Psych, Principal investigator, Kampala International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073964
- Sponsor's protocol ID
- KIU-2022-173
- Acronym
- GBV
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is due to the sensitive nature of the data and their legal implications.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06073964
- Acronym / sponsor ID
- GBV / KIU-2022-173
- Keywords
- formerly Internally Displaced Persons, Gender Based Violence, Trauma Resilience & Understanding Self-help Therapy, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Kampala International UniversityUniversity, hospital or other
- Collaborators
- Dutch Research Council (WOTRO Impact and Innovation Grants-2020), The Netherlands, Leiden University, Globalization Accessibility Innovation and Care Research Collaborative Network
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUST Intervention group | Experimental | Behavioral: Trauma Resilience & Understanding Self-help TherapyFormerly 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'. |
| 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'. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Resilience & Understanding Self-help TherapyA self-help psychosocial therapeutic intervention requiring one to undergo a basic training in its community-based utilization. | Behavioural | TRUST Intervention group |
Primary outcome
Rate of Domestic Violence Experiences
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)
Change in frequency of experiences assessed using the Assessment Screen to Identify Survivors' Toolkit for Gender Based Violence Scale.
Prevalence of Psychological Distress
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)
Change in severity of symptoms assessed using the Refugee Health Sceener-15 Scale.
Prevalence of 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)
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
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)
Change in levels of risk assessed using the Mini International Neuropsychiatric Interview guide module B for Suicidality Risk.
1 secondary outcome
Prevalence of Poor Social Economic Resilience Levels
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publicationForry, 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.
- Individual participant dataSharing planned: No. This is due to the sensitive nature of the data and their legal implications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy B Forry, MMed Psych principal investigator
Kampala International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Resilience & Understanding Self-help Therapy in people with Domestic Violence and Psychological Distress, run by Kampala International University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Domestic Violence Experiences (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.