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

NCT06289621 | Recruiting DMC

• 2 other identifiers: 2024P000420K01TW012180
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders; Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

• Patient Health Questionnaire - 9 (PHQ-9)

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

• Beck Depression Inventory (BDI)

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

• Anxiety Sensitivity Index -3

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Other Outcomes (2)

• Life Events Checklist (LEC)

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

• Alcohol Use Disorders Identification Test (AUDIT)

  pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up

Study Arms (2)

Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET)

EXPERIMENTAL

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)

Enhanced Standard Care Group

OTHER

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

Interventions

False Safety Behavioral Elimination Treatment (FSET) BEHAVIORAL

5-session transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD)

Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) Transdiagnostic Treatment ( FSET)

Enhanced Standard Care BEHAVIORAL

Participants in the enhanced standard care control group will receive treatment as usual and a list referrals.

Enhanced Standard Care Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with a primary anxiety disorder (panic disorder, generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder) or post-traumatic stress disorder.

You may not qualify if:

• Participants who are acutely suicidal, have severe alcohol of substance use disorder, or are engaged in another form of psychotherapy.

Sponsors & Collaborators

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

Study Sites (1)

Stellenbosch University

Cape Town, 8005, South Africa

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Kristina Korte, PhD

CONTACT

6177268205; kkorte@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: March 4, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

ZA (1)