K01TW012180

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

Background:
Posttraumatic Stress Disorder (PTSD) and anxiety disorders are highly prevalent and a leading cause of disability in low and middle-income countries (LMICs). My long-term career goal is to address the burden posed by these disorders by becoming a leading expert in the implementation and dissemination of evidence-based treatments (EBTs) for these disorders for use in LMICs. This goal is motivated by observations from the literature and my own work. Despite the development of 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.

Proposed Study:
The current study aims to evaluate a brief transdiagnostic treatment for anxiety disorders and PTSD (False Safety Behavior Elimination Treatment; F-SET; Schmidt et al., 2012) for use in South African primary care clinics. The aims follow a well-established implementation and dissemination model (PRISM; Feldstein & Glasgow, 2008) for all study aims. First, we will conduct in-depth qualitative interviews with patients (N=24) and providers and staff (N=10) to assess key barriers and facilitators to the implementation and sustainability of the F-SET intervention in South African primary care clinics (Specific Aim 1). Second, the F-SET intervention and implementation strategy will be adapted based on the findings from the qualitative study (Specific Aim 2). Third, we will conduct a randomized hybrid effectiveness-implementation trial to assess the effectiveness of the adapted F-SET and explore facilitators and barriers to implementation (Specific Aim 3). We will use a mixed methods approach (qualitative and quantitative) to evaluate the F-SET intervention administered by primary care nurses compared to an enhanced standard care control group in a sample of individuals with anxiety disorders and PTSD (N=60). We will evaluate the feasibility and acceptability of implementation as measured by: (1) patient participation and retention and (2) provider's perceptions of barriers and facilitators of F-SET. Provider fidelity and quality of treatment delivery will be used as moderators. These data will be used to submit an R01 for a fully powered trial with clinic randomization in year 4.

Training Aims:
This K01 proposal will provide me with training needed to achieve my long-term career goal through training in: (1) conducting culturally informed clinical trials in global mental health, (2) mixed methods research for implementation trials, and (3) implementation and dissemination science. The K01 training includes expert mentorship, extensive field-based experience in South Africa, coursework at Harvard, and publications.

The General Hospital Corporation

THE JOHN E. FOGARTY INTERNATIONAL CENTER (FIC) SUPPORTS RESEARCH AND RESEARCH TRAINING TO REDUCE DISPARITIES IN GLOBAL HEALTH AND TO FOSTER PARTNERSHIPS BETWEEN U.S. SCIENTISTS AND THEIR COUNTERPARTS ABROAD. FIC SUPPORTS BASIC BIOLOGICAL, BEHAVIORAL, AND SOCIAL SCIENCE RESEARCH, AS WELL AS RELATED RESEARCH TRAINING AND CAREER DEVELOPMENT. THE RESEARCH PORTFOLIO IS DIVIDED INTO SEVERAL PROGRAMS THAT SUPPORT A WIDE VARIETY OF FUNDING MECHANISMS TO MEET PROGRAMMATIC OBJECTIVES.

93.989 - International Research and Research Training

Fogarty International Center (FIC) [HHS - NIH]

Boston, Massachusetts 021144714 United States

Single Zip Code

International Research Scientist Development Award (IRSDA) (K01 Independent Clinical Trial Required) (PAR-21-105)

Amendment Since initial award the total obligations have increased 401% from $182,860 to $916,729.