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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Structured Clinical Interview for the DSM-5 (SCID-5) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Clinician-Administered PTSD Scale for the DSM-5 (CAPS) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Work Social Adjustment Scale (WSAS) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• General Anxiety Disorder-7 (GAD-7) [Срок оценки: pre-treatment, immediately after the last treatment session, and 3-month follow-up]
• Beck Anxiety Inventory (BAI) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Safety Aid Scale (SAS) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]

Вторичные конечные точки (4)

• Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Patient Health Questionnaire - 9 (PHQ-9) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Beck Depression Inventory (BDI) [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]
• Anxiety Sensitivity Index -3 [Срок оценки: pre-treatment, post-treatment (immediately after the last treatment session), and 3-month follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

ЮАР · 1 центр

• Stellenbosch University — Cape Town

Публикации

• 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

Идентификаторы

NCT: NCT06289621 · 2024P000420 · K01TW012180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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