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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorBabes-Bolyai University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed psychiatric disorders

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PsyPills

    Behavioral

    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.

  • MoodWheel

    Behavioral

    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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: PsyPillsExperimental treatment 1 intervention
Group B: MoodWheelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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)
3

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)
4

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

Secondary outcomes

1

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
2

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)
3

Change from Baseline Risky Behaviors at 1 month

Maintenance of reductions in risky behaviors.

Time frame
Follow-up (1 month)

Other outcomes

Sponsors and contacts

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