Menu
Recruiting NCT06289621

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

No phase Interventional Anxiety Disorders Post-traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: False Safety Behavioral Elimination Treatment (FSET), Enhanced Standard Care.
Who it may be relevant to
Registry conditions: Anxiety Disorders, Post-traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Structured Clinical Interview for the DSM-5 (SCID-5) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Clinician-Administered PTSD Scale for the DSM-5 (CAPS) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Work Social Adjustment Scale (WSAS) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • General Anxiety Disorder-7 (GAD-7) [Time frame: pre-treatment, immediately after the last treatment session, and 3-month follow-up]
  • Beck Anxiety Inventory (BAI) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Safety Aid Scale (SAS) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
Secondary outcome measures (4)
  • Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Patient Health Questionnaire - 9 (PHQ-9) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Beck Depression Inventory (BDI) [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
  • Anxiety Sensitivity Index -3 [Time frame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Africa · 1 center
  • Stellenbosch University — Cape Town

Publications

  • 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. PMID 27397584
  • 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. PMID 29733676
  • 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. PMID 22697441

Identifiers

NCT: NCT06289621 · 2024P000420 · K01TW012180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗