Clinical trial NCT04426448: Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana
Official title: The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Botswana
Sponsor class: OTHER
Collaborators: name: University of KwaZulu
First posted: 2020-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into two equal groups.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post Traumatic Checklist-5
timeFrame: baseline, week 1, 2 ,3,
measure: eSense EDA skin conductance device
timeFrame: baseline, week 1, 2 ,3,
measure: Mini International Neuropsychiatric Interview (MINI) Plus
timeFrame: baseline, week 3, one month and three months post intervention
measure: Consent rates
timeFrame: week 3
measure: Adherence rates
timeFrame: week 3
measure: knowledge of PTSD scale (KPTSD)
timeFrame: baseline, week 1, 2 ,3, one month and three months post intervention
measure: Acceptability of Intervention measure (AIM)
timeFrame: week 3
measure: Feasibility of Intervention Measure (FIM)
timeFrame: week 3
measure: Patient satisfaction scale
timeFrame: week 3
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, week 1, 2 ,3, one month and three months post intervention
measure: Clinical Outcomes in Routine Evaluation-Outcome Measure
timeFrame: baseline, week 3, one month and three months post intervention
measure: Zung self-rating anxiety scale
timeFrame: baseline, week 1, 2 ,3, one month and three months post intervention
measure: Post Traumatic Checklist-5
timeFrame: one month and three months post intervention
Other outcomes:
Locations:
city: Lobatse
country: Botswana
facility: Sbrana Psychiatric Hospital
Study officials:
affiliation: University of Botswana
name: Keneilwe Molebatsi, MMED (Psych)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.