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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289621
• Other study ID #: 2024P000420
• Secondary ID: K01TW012180
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Kristina Korte, PhD
• Phone: 6177268205
• Email: kkorte[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
South Africa	Stellenbosch University	Cape Town

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Fogarty International Center of the National Institute of Health, Harvard Medical School (HMS and HSDM), University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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