Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana

NCT04426448 | Recruiting

• 1 other identifier: UBR/RES/IRB/BIO/179
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (9)

• 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

  baseline, week 1, 2 ,3,

• eSense EDA skin conductance device

  Change in physiological arousal as measured with sensors to assess skin conductance

  baseline, week 1, 2 ,3,

• Mini International Neuropsychiatric Interview (MINI) Plus

  Assessment of symptoms meeting the criteria for PTSD

  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

  week 3

• Adherence rates

  to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.

  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.

  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

  week 3

• Feasibility of Intervention Measure (FIM)

  calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility

  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

  week 3

Secondary Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  baseline, week 1, 2 ,3, one month and three months post intervention

• Clinical Outcomes in Routine Evaluation-Outcome Measure

  baseline, week 3, one month and three months post intervention

• Zung self-rating anxiety scale

  baseline, week 1, 2 ,3, one month and three months post intervention

• Post Traumatic Checklist-5

  one month and three months post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive the BREATHE intervention for three weeks

Behavioral: Brief Relaxation, Education And Trauma HEaling

Control group

NO INTERVENTION

The participants will receive treatment as usual

Interventions

Brief Relaxation, Education And Trauma HEaling BEHAVIORAL

A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Botswana: lead
• University of KwaZulu: collaborator

Study Sites (1)

Sbrana Psychiatric Hospital

Lobatse, 0000, Botswana

RECRUITING

Related Publications (1)

• 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.

  PMID: 34479640 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Keneilwe Molebatsi, MMED (Psych)

  University of Botswana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keneilwe Molebatsi, MMED (Psychiatry)

CONTACT

+26777458378; molebatsik@ub.ac..bw

Julia Gaorekwe

CONTACT

+2673552900; gaorekwej@ub.ac.bw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into two equal groups.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: July 8, 2020
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

BO (1)