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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders; Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: False Safety Behavioral Elimination Treatment (FSET); Behavioral: Enhanced Standard Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina Korte, PhD; Phone Number: 6177268205; Email: kkorte@mgh.harvard.edu

Study Locations

• South Africa
  • Cape Town, South Africa, 8005
    • Recruiting
    • Stellenbosch University
    • Contact: Soraya Seedat, MD; Email: sseedat@sun.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: False Safety Behavioral Elimination Treatment (FSET); 5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)
Other: 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).	Behavioral: Enhanced Standard Care; Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Clinical Interview for the DSM-5 (SCID-5)	Diagnostic assessment assessing the presence or absence of a mental health diagnosis.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Clinician-Administered PTSD Scale for the DSM-5 (CAPS)	Diagnostic assessment assessing the presence or absence of post-traumatic stress disorder (PTSD)	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Work Social Adjustment Scale (WSAS)	Assessment of functional impairment. Scores range from 0 to 40 with higher scores indicating higher levels of functional impairment.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
General Anxiety Disorder-7 (GAD-7)	General measure of anxiety. Scores range from 0 to 21 with higher scores indicating greater level of anxiety.	pre-treatment, immediately after the last treatment session, and 3-month follow-up
Beck Anxiety Inventory (BAI)	Measure of anxiety symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of anxiety.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Safety Aid Scale (SAS)	Assessment of safety aid utilization and avoidance in anxiety disorders and PTSD. Higher scores indicate greater safety aid utilization.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)	PTSD symptom measure. Scores range from 0 to 80 with higher scores indicating greater level of post-traumatic stress symptoms.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Patient Health Questionnaire - 9 (PHQ-9)	Measure of emotional distress. Scores range from 0 to 20 with higher scores indicating greater emotional distress.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Beck Depression Inventory (BDI)	Measure of depressive symptoms. Scores range from 0 to 63 with higher scores indicating greater levels of depression.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Anxiety Sensitivity Index -3	Assessment of anxiety sensitivity. Scores range from 0 to 72 with higher scores indicated higher levels of anxiety sensitivity.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Events Checklist (LEC)	Assessment of exposure to traumatic events. Endorsement of events indicates the degree to which one has been exposed to traumatic events.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Alcohol Use Disorders Identification Test (AUDIT)	Assessment of alcohol use. Scores range from 0 to 40 with higher scores indicating possible problematic alcohol use.	pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); Fogarty International Center of the National Institute of Health; University of Stellenbosch

Publications and helpful links

General Publications

• Schmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.
• Riccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.
• Korte KJ, Norr AM, Schmidt NB. Targeting Safety Behaviors in the Treatment of Anxiety Disorders: A Case Study of False Safety Behavior Elimination Treatment. Am J Psychother. 2018 Jul 1;71(1):9-20. doi: 10.1176/appi.psychotherapy.20180001. Epub 2018 May 7.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2024P000420; K01TW012180 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No