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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Brief Relaxation, Education And Trauma HEaling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into two equal groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive the BREATHE intervention for three weeks | Behavioral: Brief Relaxation, Education And Trauma HEaling<br>* A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms<br>|
| No Intervention: Control group<br>The participants will receive treatment as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9 | 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 | 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. | 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 | one month and three months post intervention |