Post Traumatic Stress DisorderNCT04426448
Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana
A study testing Brief Relaxation, Education And Trauma HEaling in people with Post Traumatic Stress Disorder, run by University of Botswana at 1 site in Botswana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Brief Relaxation, Education And Trauma HEaling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBotswana
- Study dates
- 8 Jul 2020to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Botswana1 site, 1 recruiting
- Recruiting
Sbrana Psychiatric Hospital
Lobatse, 0000
Sreekanth Davu, MD Psych, +26775877248, drsdavu@gmail.com
About this study
Official title: The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Brief Relaxation, Education And Trauma HEaling
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Relaxation, Education And Trauma HEalingBehavioural
A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive the BREATHE intervention for three weeks Receives: Behavioral: Brief Relaxation, Education And Trauma HEaling |
| Control group | No intervention | The participants will receive treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, week 1, 2 ,3,
eSense EDA skin conductance device
Change in physiological arousal as measured with sensors to assess skin conductance
Measured: baseline, week 1, 2 ,3,
Mini International Neuropsychiatric Interview (MINI) Plus
Assessment of symptoms meeting the criteria for PTSD
Measured: 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
Measured: week 3
Adherence rates
to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.
Measured: 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.
Measured: 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
Measured: week 3
Feasibility of Intervention Measure (FIM)
calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility
Measured: 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
Measured: week 3
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9
Measured: 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
Measured: 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.
Measured: 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
Measured: one month and three months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jul 2020
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
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 Post Traumatic Stress DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two equal groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Botswana
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu
- Responsible party
- Principal investigator, Keneilwe Molebatsi, University of Botswana
- Investigators
- Keneilwe Molebatsi, MMED (Psych), Principal investigator, University of Botswana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426448
- Sponsor's protocol ID
- UBR/RES/IRB/BIO/179
- Status last verified
- Jul 2025
- First submitted
- 7 Jun 2020
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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.
PubMed 34479640
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
- ClinicalTrials.gov ID
- NCT04426448
- Acronym / sponsor ID
- UBR/RES/IRB/BIO/179
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of BotswanaUniversity, hospital or other
- Collaborators
- University of KwaZulu
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 11 Jun 2020 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two equal groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Brief Relaxation, Education And Trauma HEalingParticipants will receive the BREATHE intervention for three weeks |
| Control group | No intervention | –The participants will receive treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Brief Relaxation, Education And Trauma HEalingA three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms | Behavioural | Intervention group |
Primary outcome
Post Traumatic Checklist-5
Time frame: baseline, week 1, 2 ,3,
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
eSense EDA skin conductance device
Time frame: baseline, week 1, 2 ,3,
Change in physiological arousal as measured with sensors to assess skin conductance
Mini International Neuropsychiatric Interview (MINI) Plus
Time frame: baseline, week 3, one month and three months post intervention
Assessment of symptoms meeting the criteria for PTSD
Consent rates
Time frame: week 3
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
Adherence rates
Time frame: week 3
to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.
knowledge of PTSD scale (KPTSD)
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
mean difference in the scores obtained in the knowledge of PTSD scale. Higher scores indicate more knowledge of PTSD.
Acceptability of Intervention measure (AIM)
Time frame: week 3
Calculation of scores in the Acceptability of Intervention measure. Higher scores indicate greater acceptability
Feasibility of Intervention Measure (FIM)
Time frame: week 3
calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility
Patient satisfaction scale
Time frame: week 3
calculation of scores in the satisfaction scale. Higher satisfaction with the intervention will be indicated by high scores on the patient satisfaction scale
4 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
Clinical Outcomes in Routine Evaluation-Outcome Measure
Time frame: baseline, week 3, one month and three months post intervention
Zung self-rating anxiety scale
Time frame: baseline, week 1, 2 ,3, one month and three months post intervention
Post Traumatic Checklist-5
Time frame: one month and three months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 34479640Molebatsi 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.
- Individual participant dataSharing planned: 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
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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.
Keneilwe Molebatsi, MMED (Psych) principal investigator
University of Botswana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Relaxation, Education And Trauma HEaling in people with Post Traumatic Stress Disorder, run by University of Botswana at 1 site in Botswana.
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 5 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 Botswana. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keneilwe Molebatsi, MMED (Psychiatry) (+26777458378, molebatsik@ub.ac..bw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Checklist-5 (time frame: baseline, week 1, 2 ,3,). The study lists 9 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 NCT04426448, 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 30 Jul 2025.