The Effects of the PsyPills App on Emotion Regulation and Risk Behaviors in Emerging Adults: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Difficulties in Emotion Regulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Diagnosed psychiatric disorders
- •Suicide risk (score ≥ 7 on the Suicidal Behaviors Questionnaire-Revised, SBQ-R)
结局指标
主要结局
Difficulties in Emotion Regulation
时间窗: Baseline
Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) - 36 items rated on a 5-point Likert scale (1 = almost never, 5 = almost always). Total scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation
Change from Baseline Difficulties in Emotion Regulation at 2 weeks
时间窗: Post-intervention (2 weeks)
Change in DERS total and subscale scores, with higher decreases reflecting improved emotion regulation.
Change from Baseline Cognitive Emotion Regulation Strategies at 1 month
时间窗: Follow-up (1 month)
Maintenance of adaptive emotion regulation strategy use.
Change from Baseline Difficulties in Emotion Regulation at 1 month
时间窗: Follow-up (1 month)
Maintenance of change in DERS total and subscale scores.
Cognitive Emotion Regulation Strategies
时间窗: Baseline
Cognitive Emotion Regulation Questionnaire-romanian version (CERQ; Perte \& Miclea, 2011) - 36 items across 9 subscales (e.g., reappraisal, acceptance, planning). Each subscale ranges from 4 to 20; higher scores indicate greater use of that strategy.
Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks
时间窗: Post-intervention (2 weeks)
Change in adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance).
次要结局
- Change from Baseline Risky Behaviors at 2 weeks(Post-intervention (2 weeks))
- Risky Behaviors(Baseline)
- Change from Baseline Risky Behaviors at 1 month(Follow-up (1 month))
研究者
Oana David
Professor PhD
Babes-Bolyai University