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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Brief Relaxation, Education And Trauma HEaling
  A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms

Первичные конечные точки

• Post Traumatic Checklist-5 [Срок оценки: baseline, week 1, 2 ,3,]
• eSense EDA skin conductance device [Срок оценки: baseline, week 1, 2 ,3,]
• Mini International Neuropsychiatric Interview (MINI) Plus [Срок оценки: baseline, week 3, one month and three months post intervention]
• Consent rates [Срок оценки: week 3]
• Adherence rates [Срок оценки: week 3]
• knowledge of PTSD scale (KPTSD) [Срок оценки: baseline, week 1, 2 ,3, one month and three months post intervention]
• Acceptability of Intervention measure (AIM) [Срок оценки: week 3]
• Feasibility of Intervention Measure (FIM) [Срок оценки: week 3]
• Patient satisfaction scale [Срок оценки: week 3]

Вторичные конечные точки (4)

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: baseline, week 1, 2 ,3, one month and three months post intervention]
• Clinical Outcomes in Routine Evaluation-Outcome Measure [Срок оценки: baseline, week 3, one month and three months post intervention]
• Zung self-rating anxiety scale [Срок оценки: baseline, week 1, 2 ,3, one month and three months post intervention]
• Post Traumatic Checklist-5 [Срок оценки: one month and three months post intervention]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Botswana · 1 центр

• Sbrana Psychiatric Hospital — Lobatse

Публикации

• 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. PMID 34479640

Идентификаторы

NCT: NCT04426448 · UBR/RES/IRB/BIO/179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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