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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Anxiety Disorders Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET)

The anxiety disorders and post-traumatic stress disorder (PTSD) transdiagnostic treatment (FSET) is brief, 5-session, cognitive-behavioral intervention designed to treat symptoms associated with anxiety disorders and PTSD. The treatment is administered by lay providers (e.g., nurses) in primary care clinics in South Africa.

Group Type EXPERIMENTAL

False Safety Behavioral Elimination Treatment (FSET)

Intervention Type BEHAVIORAL

5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)

Enhanced Standard Care Group

The enhanced standard care group is the condition. Those in the enhanced standard care control group will receive standard care plus referrals. Upon completion of the study, they will be offered the anxiety disorder and post-traumatic stress disorder treatment (FSET).

Group Type OTHER

Enhanced Standard Care

Intervention Type BEHAVIORAL

Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

Interventions

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False Safety Behavioral Elimination Treatment (FSET)

5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)

Intervention Type BEHAVIORAL

Enhanced Standard Care

Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.