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.
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)
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
Parallel
Brief Relaxation, Education And Trauma HEaling
BehavioralA 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
eSense EDA skin conductance device
Change in physiological arousal as measured with sensors to assess skin conductance
Mini International Neuropsychiatric Interview (MINI) Plus
Assessment of symptoms meeting the criteria for PTSD
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
Patient Health Questionnaire-9 (PHQ-9)
Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9
Clinical Outcomes in Routine Evaluation-Outcome Measure
Mean difference from Baseline in the severity of psychological distress
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.
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
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University of Botswana
Lead sponsor
University of KwaZulu
Collaborator