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

Award Number: K01TW012180
ORGANIZATION: FOGARTY INTERNATIONAL CENTER
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/23/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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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 is will provide me with training needed to achieve my long-term career goal through training in: (1) the 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $183,968 )
2025	2025	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	000	5	7/22/2025	NON-COMPETING CONTINUATION	$183,968
														Subtotal = $183,968

Issue Date FY: 2024 ( Subtotal = $182,948 )
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	000	4	7/31/2024	NON-COMPETING CONTINUATION	$182,948
														Subtotal = $182,948

Issue Date FY: 2023 ( Subtotal = $182,948 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	000	3	7/24/2023	NON-COMPETING CONTINUATION	$182,948
														Subtotal = $182,948

Issue Date FY: 2022 ( Subtotal = $184,005 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	001	2	7/20/2022	NON-COMPETING CONTINUATION	$184,005
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	000	1	7/16/2022	NEW	$0
														Subtotal = $184,005

Issue Date FY: 2021 ( Subtotal = $182,860 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	International Research and Research Training	000	1	9/20/2021	NEW	$182,860
														Subtotal = $182,860

Grand Total All Awards = $916,729

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

Award Number: K01TW012180

ORGANIZATION: FOGARTY INTERNATIONAL CENTER

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/23/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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