Culturally adapted brief PTSD program for people with severe mental illness in Botswana
The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
This pilot tests whether a three-week BREATHE program can help people in Botswana who have both severe mental illness and PTSD feel better and learn to manage symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Botswana Academic / other |
| Locations | 1 site (Lobatse) |
| Trial ID | NCT04426448 on ClinicalTrials.gov |
What this trial studies
The project will first gather local descriptions of trauma experiences and provider and patient views to guide cultural adaptation of a brief psychological intervention. In the second phase the BREATHE (Brief Relaxation, Education And Trauma HEaling) intervention will be adapted for Setswana- and English-speaking patients. In the third phase forty participants with comorbid severe mental illness and PTSD recruited from Sbrana Psychiatric Hospital will be randomized 1:1 to BREATHE or usual care, with BREATHE delivered weekly over three weeks. Outcomes (PTSD, anxiety, depression, PTSD knowledge) will be measured at baseline, weekly during treatment, and at one and three months, and an objective skin conductance measure will be collected as part of the pilot evaluation.
Who should consider this trial
Good fit: Adults with a DSM-5 severe mental illness diagnosis (schizophrenia spectrum, bipolar disorder, or severe depressive disorder) who also meet criteria for PTSD, can understand Setswana or English, and are not currently receiving PTSD psychotherapy or pharmacotherapy are ideal candidates.
Not a fit: People currently receiving psychotherapy or medication for PTSD, those with recent suicidal ideation or attempts in the past six months, or those unable to consent or respond to interviews are unlikely to be eligible or benefit from this pilot.
Why it matters
Potential benefit: If successful, the intervention could provide a short, culturally tailored treatment that reduces PTSD symptoms and is feasible to deliver in Botswana's psychiatric services.
How similar studies have performed: BREATHE has shown efficacy previously among individuals with comorbid severe mental illness and PTSD in other settings, but this is the first pilot adapting and testing it specifically in Botswana.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand Setswana or English * 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: * Currently engaged in psychotherapy for PTSD * 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
Where this trial is running
Lobatse
- Sbrana Psychiatric Hospital — Lobatse, Botswana (Recruiting)
Study contacts
- Principal investigator: Keneilwe Molebatsi, MMED (Psych) — University of Botswana
- Study coordinator: Keneilwe Molebatsi, MMED (Psychiatry)
- Email: molebatsik@ub.ac..bw
- Phone: +26777458378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.