The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- eSense EDA skin conductance device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
eSense EDA skin conductance device
时间窗: baseline, week 1, 2 ,3,
Change in physiological arousal as measured with sensors to assess skin conductance
Adherence rates
时间窗: week 3
to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.
Patient satisfaction scale
时间窗: week 3
calculation of scores in the satisfaction scale. Higher satisfaction with the intervention will be indicated by high scores on the patient satisfaction scale
Post Traumatic Checklist-5
时间窗: baseline, week 1, 2 ,3,
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
Mini International Neuropsychiatric Interview (MINI) Plus
时间窗: baseline, week 3, one month and three months post intervention
Assessment of symptoms meeting the criteria for PTSD
Consent rates
时间窗: week 3
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
knowledge of PTSD scale (KPTSD)
时间窗: baseline, week 1, 2 ,3, one month and three months post intervention
mean difference in the scores obtained in the knowledge of PTSD scale. Higher scores indicate more knowledge of PTSD.
Acceptability of Intervention measure (AIM)
时间窗: week 3
Calculation of scores in the Acceptability of Intervention measure. Higher scores indicate greater acceptability
Feasibility of Intervention Measure (FIM)
时间窗: week 3
calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility
次要结局
- Zung self-rating anxiety scale(baseline, week 1, 2 ,3, one month and three months post intervention)
- Post Traumatic Checklist-5(one month and three months post intervention)
- Patient Health Questionnaire-9 (PHQ-9)(baseline, week 1, 2 ,3, one month and three months post intervention)
- Clinical Outcomes in Routine Evaluation-Outcome Measure(baseline, week 3, one month and three months post intervention)
研究者
Keneilwe Molebatsi
Principal Investigator
University of Botswana