NCT06289621

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

Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anxiety Disorders
• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	False Safety Behavioral Elimination Treatment (FSET)	5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)
BEHAVIORAL	Enhanced Standard Care	Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2024-03-04
• Last updated: 2024-07-17

Locations

1 site across 1 country: South Africa