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

Babes-Bolyai University

Status: Not yet enrolling

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

Treatments: Behavioral: MoodWheel; Behavioral: PsyPills

Study type: Interventional

Funder types: Other

Identifiers

NCT07304830

PsyPills-Risk-Behaviors

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

PsyPills

Experimental group

Description:

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.

Treatment:

Behavioral: PsyPills

MoodWheel

Active Comparator group

Description:

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:

Behavioral: MoodWheel