The Effects of the PsyPills App on Emotion Regulation and Risk Behaviors in Emerging Adults: A Randomized Clinical Trial

Обзор

This study aims to investigate the effects of the PsyPills mobile application on improving emotion regulation and reducing risk behaviors among emerging adults. PsyPills is a self-guided psychological intervention based on Rational-Emotive and Behavioral Therapy (REBT) principles and the Just-in-Time Adaptive Intervention (JITAI) framework. The app provides short, contextually adaptive "psychological pills," or cognitive restructuring exercises, designed to help users replace irrational beliefs with rational alternatives in moments of emotional distress. The study will compare PsyPills app with an active control condition using the MoodWheel app, which supports emotional monitoring without therapeutic content.

Подробное описание

The research design will be a 2-arm controlled clinical trial, with 3 waves of data collection. This single-blind, randomized controlled study will evaluate the efficacy of the PsyPills app in enhancing emotion regulation and reducing engagement in risky behaviors among emerging adults aged 18-29. Participants will complete demographic questions and the Suicidal Behaviors Questionnaire-Revised (SBQ-R) for safety screening. Participants will additionally complete baseline measurements for primary and secondary outcomes. Next, eligible participants will be enrolled and randomly assigned (1:1) to one of two conditions: PsyPills app (experimental group) or MoodWheel app (active control group). Among the constructs evaluated are emotion regulation difficulties; cognitive emotion regulation strategies and risky behaviors (substance use, risky sexual behavior, self-harm, aggression, disordered eating). Both intervention groups will use their assigned mobile application for a two-week period, with a minimum usage frequency of 3 sessions per week. The PsyPills app allows users to monitor and label emotions and delivers short, adaptive cognitive-behavioral interventions ("psychological pills") based on REBT principles and the JITAI framework, aiming to improve emotion regulation in real time by using rational thinking strategies to change the intensity of dysfunctional emotionality. The MoodWheel app serves as an active control, simply allowing users to monitor and label emotions without providing cognitive restructuring or feedback.

Вмешательства

• Поведенческое PsyPills
  A self-guided mobile intervention based on Rational-Emotive and Behavioral Therapy (REBT) principles and the Just-in-Time Adaptive Intervention (JITAI) framework. Provides short, adaptive "psychological pills" - personalized cognitive restructuring exercises aimed at identifying and replacing irrational beliefs, reducing dysfunctional emotionality, and improving emotion regulation.
• Поведенческое MoodWheel
  The active control condition involves using the MoodWheel app, designed for emotional self-monitoring without therapeutic content. Participants label and track their emotional states, but the app does not provide cognitive restructuring, feedback, or intervention elements.

Первичные конечные точки

• Difficulties in Emotion Regulation [Срок оценки: Baseline]
• Change from Baseline Difficulties in Emotion Regulation at 2 weeks [Срок оценки: Post-intervention (2 weeks)]
• Change from Baseline Difficulties in Emotion Regulation at 1 month [Срок оценки: Follow-up (1 month)]
• Cognitive Emotion Regulation Strategies [Срок оценки: Baseline]
• Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks [Срок оценки: Post-intervention (2 weeks)]
• Change from Baseline Cognitive Emotion Regulation Strategies at 1 month [Срок оценки: Follow-up (1 month)]

Вторичные конечные точки (3)

• Risky Behaviors [Срок оценки: Baseline]
• Change from Baseline Risky Behaviors at 2 weeks [Срок оценки: Post-intervention (2 weeks)]
• Change from Baseline Risky Behaviors at 1 month [Срок оценки: Follow-up (1 month)]

Критерии участия

Критерии включения

• High emotional regulation difficulties, but not severe (DERS total score 88-105)
• At least one risky behavior with a frequency ≥ 2 on the RBQ Frequency Scale
• Access to an Android or iOS smartphone

Критерии исключения

• Diagnosed psychiatric disorders
• Suicide risk (score ≥ 7 on the Suicidal Behaviors Questionnaire-Revised, SBQ-R)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Румыния · 1 центр

• Babes-Bolyai University — Cluj-Napoca

Публикации

• Weiss NH, Tull MT, Dixon-Gordon K, Gratz KL. Assessing the Negative and Positive Emotion-Dependent Nature of Risky Behaviors Among Substance Dependent Patients. Assessment. 2018 Sep;25(6):702-715. doi: 10.1177/1073191116665906. Epub 2016 Aug 30. PMID 27581175
• Perte, A. & Miclea, Mircea. (2011). The standardization of the cognitive emotion regulation questionnaire (CERQ) on Romanian population. Cognition Brain and Behavior. 15. 111-130.
• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26(1), 41-54.

Идентификаторы

NCT: NCT07304830 · PsyPills-Risk-Behaviors

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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