Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana
NCT ID: NCT04426448
Last Updated: 2025-07-30
Study Results
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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RECRUITING
NA
36 participants
INTERVENTIONAL
2020-07-08
2025-08-30
Brief Summary
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The study will be conducted in three phases. The first phase will determine a description of trauma and responses to traumatic experiences among patients with severe mental illness. The first phase of the study will also determine participants' and mental health care providers' perceptions of suitable PTSD interventions in this middle-income context. The findings will then be used to culturally adapt the brief intervention in the second phase. A pilot trial will be conducted in the third phase of the study.
Participants with comorbid SMI and PTSD will be randomized into two groups (n= 20 intervention group, n= 20 control group). Outcomes of the intervention such as the severity of PTSD symptoms, knowledge about PTSD will be assessed at baseline and at different timelines during the study.
This study will fill the knowledge gap on trauma and its consequences among individuals with severe mental illness in Botswana, it will also contribute to the improvement of clinical practice in the management of PTSD and SMI.
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Detailed Description
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The intervention will be delivered by the Principal Investigator who has received training from the intervention developer. Supervision will be provided telephonically.
The BREATHE intervention will be delivered weekly for each participant for a total of three weeks and 4 participants will be enrolled per group resulting in a total of 5 groups. The estimated period of intervention delivery and data collection is therefore expected to last for a period of \~15 weeks.
Outcomes such as anxiety, depressive and PTSD Symptoms, and knowledge about PTSD will be assessed before participants receive the intervention, weekly (following each treatment session), month one and month three after treatment completion. Assessment of feasibility and acceptability will be done at treatment completion with the intervention group. Participants on the control arm will receive outcome measures at the same time points as those receiving the intervention. The investigators will utilize an objective assessment of skin conductance which has been shown to be greater in individuals with PTSD than in individuals without PTSD and similarly increased during a trauma interview in individuals with PTSD compared to individuals who do not have PTSD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Participants will receive the BREATHE intervention for three weeks
Brief Relaxation, Education And Trauma HEaling
A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
Control group
The participants will receive treatment as usual
No interventions assigned to this group
Interventions
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Brief Relaxation, Education And Trauma HEaling
A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
Eligibility Criteria
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Inclusion Criteria
* The patient must meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for any SMI as categorized for this study (schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar mood disorder, and severe depressive disorder)
* The patient should meet the criteria for Post-Traumatic Stress Disorder as assessed with the Post Traumatic Checklist-5 (PCL-5)
Exclusion Criteria
* On pharmacotherapy management of PTSD (to control for medication effects on PTSD symptoms)
* Inability to understand informed consent
* Inability to respond to interview questions
* Patients who have suicidal ideation and history of a suicide attempt within the past 6 months
18 Years
ALL
No
Sponsors
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University of KwaZulu
OTHER
University of Botswana
OTHER
Responsible Party
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Keneilwe Molebatsi
Principal Investigator
Principal Investigators
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Keneilwe Molebatsi, MMED (Psych)
Role: PRINCIPAL_INVESTIGATOR
University of Botswana
Locations
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Sbrana Psychiatric Hospital
Lobatse, , Botswana
Countries
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Central Contacts
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Facility Contacts
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References
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Molebatsi K, Ng LC, Chiliza B. A culturally adapted brief intervention for post-traumatic stress disorder in people with severe mental illness in Botswana: protocol for a randomised feasibility trial. Pilot Feasibility Stud. 2021 Sep 3;7(1):170. doi: 10.1186/s40814-021-00904-1.
Other Identifiers
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UBR/RES/IRB/BIO/179
Identifier Type: -
Identifier Source: org_study_id
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