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

What this Trial Is About

Researchers are evaluating a brief psychological intervention adapted to the cultural context of Botswana for people with Post-Traumatic Stress Disorder (PTSD) who also have severe mental illness (SMI). The study aims to assess how effective, feasible, and acceptable this intervention is through a pilot trial. It addresses a knowledge gap about trauma and its effects among individuals with SMI in Botswana and seeks to improve clinical care for these conditions. The study will be conducted in three phases: first, understanding trauma and responses among patients with SMI and gathering views on suitable PTSD treatments; second, culturally adapting the intervention based on these findings; and third, conducting a pilot trial. In this trial, 40 participants will be randomly assigned to receive either the BREATHE intervention, which includes psychoeducation and breathing exercises over three weekly sessions, or usual treatment. The intervention is delivered by a trained investigator with remote supervision. Participants will be assessed multiple times, including before treatment, weekly during the three intervention weeks, and at one and three months after treatment ends. Measures include PTSD symptom severity, knowledge about PTSD, anxiety, depression, and physiological responses to trauma using a skin conductance device. The study also evaluates treatment feasibility, acceptability, adherence, and patient satisfaction, with data collection expected to span about 15 weeks.

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