Not Yet RecruitingNot Applicable

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

Romania204 participantsStarted 2026-01

Plain-language 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.

Who can participate

Age range

18 Years – 29 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difficulties in Emotion Regulation

Timeframe: Baseline

Change from Baseline Difficulties in Emotion Regulation at 2 weeks

Timeframe: Post-intervention (2 weeks)

Change from Baseline Difficulties in Emotion Regulation at 1 month

Timeframe: Follow-up (1 month)

Cognitive Emotion Regulation Strategies

Timeframe: Baseline

Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks

Timeframe: Post-intervention (2 weeks)

Change from Baseline Cognitive Emotion Regulation Strategies at 1 month

Timeframe: Follow-up (1 month)

Trial details

NCT IDNCT07304830

SponsorBabes-Bolyai University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Oana David, Ph.D

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

View on ClinicalTrials.gov More Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating) trials

Plain-language summary

Who can participate

Age range

18 Years – 29 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Difficulties in Emotion Regulation

Timeframe: Baseline

Change from Baseline Difficulties in Emotion Regulation at 2 weeks

Timeframe: Post-intervention (2 weeks)

Change from Baseline Difficulties in Emotion Regulation at 1 month

Timeframe: Follow-up (1 month)

Cognitive Emotion Regulation Strategies

Timeframe: Baseline

Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks

Timeframe: Post-intervention (2 weeks)

Change from Baseline Cognitive Emotion Regulation Strategies at 1 month

Timeframe: Follow-up (1 month)