Study of a 5-Session Transdiagnostic Treatment for Anxiety and PTSD Delivered by Nurses in South African Clinics Compared to Enhanced Standard Care

What this Trial Is About

Researchers are evaluating a brief transdiagnostic treatment called False Safety Behavior Elimination Treatment F-SET for anxiety disorders and post-traumatic stress disorder PTSD in South Africa. This study addresses the high prevalence and disability caused by these disorders in low and middle-income countries, where access to effective evidence-based treatments is limited. The trial compares this brief intervention to an enhanced standard care control group to assess its effectiveness and ease of implementation in primary care settings. The study involves two groups one receiving the F-SET intervention, which consists of five cognitive-behavioral therapy sessions delivered by non-specialist providers such as nurses in primary care clinics, and the other receiving enhanced standard care, which includes usual treatment plus referrals. After the study, participants in the enhanced standard care group will be offered the F-SET treatment. This hybrid effectiveness-implementation trial examines both clinical outcomes and factors affecting delivery of the intervention. Participants will be evaluated before treatment, immediately after the last session, and at a three-month follow-up using several measures, including interviews and questionnaires assessing anxiety, PTSD symptoms, depression, social adjustment, and safety behaviors. The study monitors changes using tools like the Structured Clinical Interview for DSM-5, Clinician-Administered PTSD Scale, General Anxiety Disorder-7, Beck Anxiety Inventory, and others. All assessments and follow-ups are planned to track treatment impact and participant progress over time.

Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa