False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders.
Christina J Riccardi, Kristina J Korte, Norman B Schmidt
https://pubmed.ncbi.nlm.nih.gov/27397584Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06289621
Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
Led by Massachusetts General Hospital · Updated on 2024-07-17
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
University of Stellenbosch
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a brief transdiagnostic treatment called False Safety Behavior Elimination Treatment (F-SET) for anxiety disorders and post-traumatic stress disorder (PTSD) in South Africa. This study addresses the high prevalence and disability caused by these disorders in low and middle-income countries, where access to effective evidence-based treatments is limited. The trial compares this brief intervention to an enhanced standard care control group to assess its effectiveness and ease of implementation in primary care settings. The study involves two groups: one receiving the F-SET intervention, which consists of five cognitive-behavioral therapy sessions delivered by non-specialist providers such as nurses in primary care clinics, and the other receiving enhanced standard care, which includes usual treatment plus referrals. After the study, participants in the enhanced standard care group will be offered the F-SET treatment. This hybrid effectiveness-implementation trial examines both clinical outcomes and factors affecting delivery of the intervention. Participants will be evaluated before treatment, immediately after the last session, and at a three-month follow-up using several measures, including interviews and questionnaires assessing anxiety, PTSD symptoms, depression, social adjustment, and safety behaviors. The study monitors changes using tools like the Structured Clinical Interview for DSM-5, Clinician-Administered PTSD Scale, General Anxiety Disorder-7, Beck Anxiety Inventory, and others. All assessments and follow-ups are planned to track treatment impact and participant progress over time.
CONDITIONS
Brief Title
Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder
You will not qualify if you...
- Acutely suicidal individuals
- Severe alcohol or substance use disorder
- Currently engaged in another form of psychotherapy
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 5 sessions
Participants receive a brief, 5-session transdiagnostic cognitive-behavioral treatment to address symptoms of anxiety disorders and PTSD.
5 weekly visits (in-person)
Follow-up
Duration - 3 months
Participants are monitored for treatment effects and symptom changes after completing the treatment sessions.
1 follow-up visit at 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Stellenbosch University
Cape Town, South Africa, 8005
Actively Recruiting
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Research Team
K
Kristina Korte, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Targeting Safety Behaviors in the Treatment of Anxiety Disorders: A Case Study of False Safety Behavior Elimination Treatment.
Kristina J Korte, Aaron M Norr, Norman B Schmidt
https://pubmed.ncbi.nlm.nih.gov/29733676Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology.
Norman B Schmidt, Julia D Buckner, Andrea Pusser...
https://pubmed.ncbi.nlm.nih.gov/22697441