Culturally adapted brief PTSD program for people with severe mental illness in Botswana
Official title: The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
Run by University of Botswana · NCT04426448 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Botswana Academic / other |
| Locations | 1 site (Lobatse) |
| Status | Recruiting |
| Started | July 8, 2020 |
| Main results expected | August 30, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT04426448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Anger, Social Thinking, and PTSD in French Veterans
This study tests whether PTSD in former French military personnel is linked to higher anger through changes in social thinking abilities.
-
TSND-201 treatment for PTSD in adults
This study tests two doses of TSND-201 or placebo to see if it helps adults with PTSD.
-
Long-term outcomes after Hyperbaric Oxygen Therapy in veterans with TBI, PCS, or PTSD
This study tests whether benefits from HBOT persist over time for veterans with brain injury or related conditions.
-
SEE FAR CBT for Adults With PTSD
This 12-week, one-on-one SEE FAR CBT program tests a trauma-focused therapy to see if PTSD symptoms improve in adults 18 and older.
-
Brief SEE FAR CBT: a short, focused therapy for adults with PTSD
A 6-session Brief SEE FAR CBT treatment is tested against usual dynamic psychotherapy for adults with PTSD to see if it reduces symptoms.
-
MDMA Therapy for PTSD in Veterans
This phase 2 study tests a fixed 120 mg dose of MDMA, followed by a 60 mg supplemental dose, plus therapy, to see if it helps adults who are veterans with PTSD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.