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

Last updated: July 15, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Post-traumatic Stress Disorders

Panic Disorders

Treatment

Enhanced Standard Care

False Safety Behavioral Elimination Treatment (FSET)

Clinical Study ID

NCT06289621
2024P000420
K01TW012180
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with a primary anxiety disorder (panic disorder, generalizedanxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) orpost-traumatic stress disorder.

Exclusion

Exclusion Criteria:

  • Participants who are acutely suicidal, have severe alcohol of substance usedisorder, or are engaged in another form of psychotherapy.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Enhanced Standard Care
Phase:
Study Start date:
May 08, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Stellenbosch University

    Cape Town, 8005
    South Africa

    Active - Recruiting

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