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

NCT07304830 | Not Yet Recruiting

• 1 other identifier: PsyPills-Risk-Behaviors
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating)

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  Post-intervention (2 weeks)

• Change from Baseline Difficulties in Emotion Regulation at 1 month

  Maintenance of change in DERS total and subscale scores.

  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.

  Baseline

• Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks

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

  Post-intervention (2 weeks)

• Change from Baseline Cognitive Emotion Regulation Strategies at 1 month

  Maintenance of adaptive emotion regulation strategy use.

  Follow-up (1 month)

Secondary Outcomes (3)

• Risky Behaviors

  Baseline

• Change from Baseline Risky Behaviors at 2 weeks

  Post-intervention (2 weeks)

• Change from Baseline Risky Behaviors at 1 month

  Follow-up (1 month)

Study Arms (2)

PsyPills

EXPERIMENTAL

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

MoodWheel

ACTIVE COMPARATOR

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

Interventions

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.

PsyPills

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.

MoodWheel

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

Location

Related Publications (3)

• 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 RESULT

• Perte, A. & Miclea, Mircea. (2011). The standardization of the cognitive emotion regulation questionnaire (CERQ) on Romanian population. Cognition Brain and Behavior. 15. 111-130.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Self-Injurious Behavior; Aggression

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Central Study Contacts

Oana David, Ph.D

CONTACT

+105 40-264-434141; oanadavid@psychology.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)