The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Botswana
Sbrana Psychiatric Hospital
RECRUITING
Lobatse
Contact Information
Primary
Keneilwe Molebatsi, MMED (Psychiatry)
molebatsik@ub.ac..bw
+26777458378
Backup
Julia Gaorekwe
gaorekwej@ub.ac.bw
+2673552900
Time Frame
Start Date: 2020-07-08
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 36
Treatments
Experimental: Intervention group
Participants will receive the BREATHE intervention for three weeks
No_intervention: Control group
The participants will receive treatment as usual
Related Therapeutic Areas
Sponsors
Leads: University of Botswana
Collaborators: University of KwaZulu

This content was sourced from clinicaltrials.gov

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