An interventional study of Brief Relaxation, Education And Trauma HEaling in Post Traumatic Stress Disorder, sponsored by University of Botswana. Recruiting at 1 site in Botswana. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University of Botswana · Not applicable, Interventional, and Treatment
The purpose of this study is to culturally adapt a brief psychological intervention for Post-Traumatic Stress Disorder (PTSD) and assess its efficacy, feasibility, and acceptability in a pilot trial. The intervention has been shown to be efficacious among individuals with comorbid severe mental illness (SMI) and PTSD.
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.
Study participants will be recruited from Sbrana Psychiatric Hospital, the only referral psychiatric hospital in Botswana. The hospital population is representative of the culturally diverse Botswana nation because patients with severe mental illness from the entire country are admitted to the hospital. Forty participants (40) will be recruited and randomized to receive the Brief Relaxation, Education, And Trauma HEaling (BREATHE) intervention or treatment as usual.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 36 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →University of Botswana is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the BREATHE intervention for three weeks
Behavioral: Brief Relaxation, Education And Trauma HEaling
The participants will receive treatment as usual
A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
Post Traumatic Checklist-5
Mean Change from Baseline in the severity of PTSD symptoms as assessed with the PCL-5. Total scores for the Post Traumatic Checklist-5 range between 0 and 80 with a cut off score of 33 or higher suggesting the patient may benefit from PTSD treatment. Patients with scores lower than 33 may indicate the patient has sub-threshold symptoms of PTSD
Time frame: baseline, week 1, 2 ,3,
eSense EDA skin conductance device
Change in physiological arousal as measured with sensors to assess skin conductance
Time frame: baseline, week 1, 2 ,3,
Mini International Neuropsychiatric Interview (MINI) Plus
Assessment of symptoms meeting the criteria for PTSD
Time frame: baseline, week 3, one month and three months post intervention
Consent rates
to assess the acceptability of the intervention by dividing the number of participants who meet the criteria for PTSD and meet the inclusion criteria for the pilot trial by the number of those who consent to participate in the trial
Time frame: week 3
Adherence rates
to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.
Time frame: week 3
knowledge of PTSD scale (KPTSD)
mean difference in the scores obtained in the knowledge of PTSD scale. Higher scores indicate more knowledge of PTSD.
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
Acceptability of Intervention measure (AIM)
Calculation of scores in the Acceptability of Intervention measure. Higher scores indicate greater acceptability
Time frame: week 3
Feasibility of Intervention Measure (FIM)
calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility
Time frame: week 3
Patient satisfaction scale
calculation of scores in the satisfaction scale. Higher satisfaction with the intervention will be indicated by high scores on the patient satisfaction scale
Time frame: week 3
Patient Health Questionnaire-9 (PHQ-9)
Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
Clinical Outcomes in Routine Evaluation-Outcome Measure
Mean difference from Baseline in the severity of psychological distress
Time frame: baseline, week 3, one month and three months post intervention
Zung self-rating anxiety scale
Mean Change from Baseline in the severity of anxiety symptoms as assessed with the Zung anxiety rating scale. Total scores in the Zung self rating scale range from 20 to 80, with scores above 26 indicating severe and extremely severe anxiety.
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
Post Traumatic Checklist-5
Mean Change from Baseline in the severity of PTSD symptoms as assessed with the Post Traumatic Checklist-5. A five points difference in the total score is an indication that a patient has responded to treatment and 10 points has been determined as a minimum threshold for determining whether the improvement has clinical utility
Time frame: one month and three months post intervention
Plan to share: Yes — The study will be conducted in fulfillment of a Doctor of Philosophy in Psychiatry degree. De-identified data will be shared with the supervisors
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Throughout the study period and one year after completion of write-up
Access criteria: de-identified coded data will be stored and shared as a statistical package for the social sciences (SPSS) file.
Started Jul 2020 (actual). Primary completion is estimated for Aug 2025, 61 months after the start.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 61 months is above that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic →
University of Botswana