An interventional study of PsyPills and MoodWheel in Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating), sponsored by Babes-Bolyai University. Not yet recruiting at 1 site in Romania. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment
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.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 204 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
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Exclusion Criteria:
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.
Behavioral: PsyPills
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.
Behavioral: MoodWheel
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.
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.
Difficulties in Emotion Regulation
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
Time frame: Baseline
Change from Baseline Difficulties in Emotion Regulation at 2 weeks
Change in DERS total and subscale scores, with higher decreases reflecting improved emotion regulation.
Time frame: Post-intervention (2 weeks)
Change from Baseline Difficulties in Emotion Regulation at 1 month
Maintenance of change in DERS total and subscale scores.
Time frame: Follow-up (1 month)
Cognitive Emotion Regulation Strategies
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.
Time frame: Baseline
Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks
Change in adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance).
Time frame: Post-intervention (2 weeks)
Change from Baseline Cognitive Emotion Regulation Strategies at 1 month
Maintenance of adaptive emotion regulation strategy use.
Time frame: Follow-up (1 month)
Risky Behaviors
Risky Behavior Questionnaire (RBQ; Weiss et al., 2018) - self-report scale assessing the frequency and emotional context (negative and positive affect) of risky behaviors such as substance use, risky sexual behavior, self-harm, aggression, and disordered eating. Higher scores indicate higher engagement in risky behaviors.
Time frame: Baseline
Change from Baseline Risky Behaviors at 2 weeks
Change in RBQ total and subscale scores, with reductions reflecting decreased engagement in risky behaviors.
Time frame: Post-intervention (2 weeks)
Change from Baseline Risky Behaviors at 1 month
Maintenance of reductions in risky behaviors.
Time frame: Follow-up (1 month)
Plan to share: No
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Babes-Bolyai University