Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders

Официальное название

Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders: a Randomized Controlled Trial Using a Mixed Methods Approach

Обзор

The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are: 1. Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures. 2. The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods. 3. Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE. 4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Подробное описание

Anxiety Disorders are one of the most prevalent psychological problems around the world and if not treated they tend to become chronic. Cognitive Behavioral Therapy (CBT) is the treatment of choice, being the component of in vivo exposure (IVE) the central feature. Despite its efficacy it is still a hard component to implement for the patients. Information and Communication Technologies (ICT) can help assisting and/or applying psychological interventions. The proposed study will fill the existing gap in this sense as it will assess the efficacy of a fully configurable, sensor-guided and location-based (GPS) app for the in vivo exposure component. It will also address the shortage of clinical validation studies of mHealth apps thanks to the proposed RCT. The study will expand our knowledge about the use of technologies in mental health problems and help improve the effectiveness of exposure therapy.

Вмешательства

• Поведенческое Cognitive behavioral therapy with in vivo exposure
  CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component w
• Поведенческое Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT
  CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component w

Первичные конечные точки

• Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Fear and avoidance scales [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]

Вторичные конечные точки (12)

• Severity Measure for Specific Phobia - Adult [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Acrophobia Questionnaire [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Claustrophoby Questionnaire [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Fear of Flying Questionnaire II [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Anxiety Sensitivity Inventory [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Fear Questionnaire (FQ) [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Social Interaction Anxiety Inventory (SIAS) [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Fear of negative evaluation scale [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Social avoidance and distress scale [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Panic Disorder Severity Scale (PDSS-SR) [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Agoraphobia Inventory [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]
• Overall Depression Severity and Impairment Scale [Срок оценки: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)]

Критерии участия

Критерии включения

• Being at least 18 years or older.
• Meeting DSM-5 diagnostic criteria (APA, 2013) for anxiety disorder, specifically specific phobia, agoraphobia, panic disorder and social phobia.
• Being willing to follow the study conditions.
• Sign the consent form.

Критерии исключения

• Having another psychological problem that requires immediate attention.
• Having current alcohol or drug dependence or abuse, psychosis or severe organic illness.
• Currently being treated in a similar treatment program.
• Taking anxiolytics during the study (or in the case of taking them, changing drug or dose during the study).

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

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University Jaume I — Castellon

Публикации

• Plaisier I, Beekman AT, de Graaf R, Smit JH, van Dyck R, Penninx BW. Work functioning in persons with depressive and anxiety disorders: the role of specific psychopathological characteristics. J Affect Disord. 2010 Sep;125(1-3):198-206. doi: 10.1016/j.jad.2010.01.072. Epub 2010 Feb 24. PMID 20185180
• Miralles I, Granell C, Diaz-Sanahuja L, Van Woensel W, Breton-Lopez J, Mira A, Castilla D, Casteleyn S. Smartphone Apps for the Treatment of Mental Disorders: Systematic Review. JMIR Mhealth Uhealth. 2020 Apr 2;8(4):e14897. doi: 10.2196/14897. PMID 32238332
• Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow. PMID 26487813

Идентификаторы

NCT: NCT06788119 · UJaumeI_Symptoms_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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