Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for the DSM-5 (CAPS)
研究概览
简要总结
The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group.
详细描述
Post-traumatic stress disorder (PTSD) and anxiety disorders are highly prevalent and a leading cause of disability in low and middle-income countries (LMICs). Despite the development of evidence-based treatments (EBTs), an overwhelming majority of those in need (i.e., 85%) in LMICs do not receive treatment and, when they do, it is not empirically based. Despite the clear need for EBTs in LMICs, there are three primary barriers associated with the implementation of EBTs in these areas. These barriers include: (1) EBTs tend to be single disorder focused only treating one disorder at a time, (2) they are long in duration (e.g., 12-16 treatment sessions to treat one disorder), and (3) they tend to be complex and require a high level of skill to administer. Given the low availability of highly trained providers in LMICs, using an approach that is brief, culturally congruent, and less complex than typical EBTs is ideal for reducing these barriers. The current study aims to evaluate the use of a brief transdiagnostic treatment for anxiety disorders and PTSD (False Safety Behavior Elimination Treatment; F-SET) in South African primary care clinics. The current study is a Type 1 hybrid effectiveness-implementation trial assessing the effectiveness of the adapted brief transdiagnostic intervention and to explore facilitators and barriers to implementation. The adapted intervention is being compared to an enhanced standard care control condition.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.
排除标准
- •Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
结局指标
主要结局
Clinician-Administered PTSD Scale for the DSM-5 (CAPS)
时间窗: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Diagnostic assessment assessing the presence or absence of post-traumatic stress disorder (PTSD)
General Anxiety Disorder-7 (GAD-7)
时间窗: pre-treatment, immediately after the last treatment session, and 3-month follow-up
General measure of anxiety. Scores range from 0 to 21 with higher scores indicating greater level of anxiety.
Structured Clinical Interview for the DSM-5 (SCID-5)
时间窗: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Diagnostic assessment assessing the presence or absence of a mental health diagnosis.
Work Social Adjustment Scale (WSAS)
时间窗: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Assessment of functional impairment. Scores range from 0 to 40 with higher scores indicating higher levels of functional impairment.
Beck Anxiety Inventory (BAI)
时间窗: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Measure of anxiety symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of anxiety.
Safety Aid Scale (SAS)
时间窗: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Assessment of safety aid utilization and avoidance in anxiety disorders and PTSD. Higher scores indicate greater safety aid utilization.
次要结局
- Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)(pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
- Patient Health Questionnaire - 9 (PHQ-9)(pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
- Beck Depression Inventory (BDI)(pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
- Anxiety Sensitivity Index -3(pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
研究者
Kristina Korte
Assistant Professor
Massachusetts General Hospital