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NCT Number: NCT07304830

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

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Key information

Conditions

Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating) Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Self-Injurious Behavior Social Behavior Substance-Related Disorders

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Difficulties in Emotion Regulation

    Time frame: 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

  2. Change from Baseline Difficulties in Emotion Regulation at 2 weeks

    Time frame: Post-intervention (2 weeks)

    Change in DERS total and subscale scores, with higher decreases reflecting improved emotion regulation.

  3. Change from Baseline Difficulties in Emotion Regulation at 1 month

    Time frame: Follow-up (1 month)

    Maintenance of change in DERS total and subscale scores.

  4. Cognitive Emotion Regulation Strategies

    Time frame: 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.

  5. Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks

    Time frame: Post-intervention (2 weeks)

    Change in adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance).

  6. Change from Baseline Cognitive Emotion Regulation Strategies at 1 month

    Time frame: Follow-up (1 month)

    Maintenance of adaptive emotion regulation strategy use.

Secondary outcomes

  1. Risky Behaviors

    Time frame: Baseline

    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.

  2. Change from Baseline Risky Behaviors at 2 weeks

    Time frame: Post-intervention (2 weeks)

    Change in RBQ total and subscale scores, with reductions reflecting decreased engagement in risky behaviors.

  3. Change from Baseline Risky Behaviors at 1 month

    Time frame: Follow-up (1 month)

    Maintenance of reductions in risky behaviors.

Study contacts

Contact information is provided by the study sponsor or research team.

Oana David, Ph.D

CONTACT

[email protected]

+105 40-264-434141

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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