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

NCT ID: NCT07304830

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PsyPills

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.

Group Type EXPERIMENTAL

PsyPills

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

MoodWheel

Intervention Type 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.

Interventions

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PsyPills

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.

Intervention Type BEHAVIORAL

MoodWheel

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Oana David

Professor PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Babes-Bolyai University

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

Central Contacts

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Oana David, Ph.D

Role: CONTACT

Phone: +105 40-264-434141

Email: [email protected]

Facility Contacts

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Avalon

Role: primary

References

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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.

Reference Type RESULT
PMID: 27581175 (View on PubMed)

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

Reference Type 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.

Reference Type RESULT

Other Identifiers

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PsyPills-Risk-Behaviors

Identifier Type: -

Identifier Source: org_study_id