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

NCT06289621 · Massachusetts General Hospital
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Official title
Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
About this study
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.
Eligibility criteria
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. Exclusion Criteria: * Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-05-08
Estimated completion: 2026-12-31
Last updated: 2024-07-17
Interventions
Behavioral: False Safety Behavioral Elimination Treatment (FSET)Behavioral: Enhanced Standard Care
Primary outcomes
  • Structured Clinical Interview for the DSM-5 (SCID-5) (pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
  • Clinician-Administered PTSD Scale for the DSM-5 (CAPS) (pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
  • Work Social Adjustment Scale (WSAS) (pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up)
Sponsor
Massachusetts General Hospital · other
With: University of Stellenbosch, Fogarty International Center of the National Institute of Health, Harvard Medical School (HMS and HSDM)
Contacts & investigators
ContactKristina Korte, PhD · contact · kkorte@mgh.harvard.edu · 6177268205
All locations (1)
Stellenbosch UniversityRecruiting
Cape Town, South Africa
Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa · TrialPath