Clinical trial NCT06289621: Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa
Official title: Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Post-traumatic Stress Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
name: Fogarty International Center of the National Institute of Health
name: Harvard Medical School (HMS and HSDM)
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Structured Clinical Interview for the DSM-5 (SCID-5)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Clinician-Administered PTSD Scale for the DSM-5 (CAPS)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Work Social Adjustment Scale (WSAS)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: pre-treatment, immediately after the last treatment session, and 3-month follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Safety Aid Scale (SAS)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Secondary outcomes:
measure: Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Beck Depression Inventory (BDI)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Anxiety Sensitivity Index -3
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Other outcomes:
measure: Life Events Checklist (LEC)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up
Locations:
city: Cape Town
country: South Africa
facility: Stellenbosch University
Study officials:
References:
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.
citation: 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.
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.