Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating)
Conditions
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.
Detailed 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.
Interventions
BEHAVIORALPsyPills
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.
BEHAVIORALMoodWheel
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.
Sponsors
Babes-Bolyai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties in Emotion Regulation | 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 |
| Change from Baseline Difficulties in Emotion Regulation at 2 weeks | Post-intervention (2 weeks) | Change in DERS total and subscale scores, with higher decreases reflecting improved emotion regulation. |
| Change from Baseline Difficulties in Emotion Regulation at 1 month | Follow-up (1 month) | Maintenance of change in DERS total and subscale scores. |
| Cognitive Emotion Regulation Strategies | 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. |
| Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks | Post-intervention (2 weeks) | Change in adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance). |
| Change from Baseline Cognitive Emotion Regulation Strategies at 1 month | Follow-up (1 month) | Maintenance of adaptive emotion regulation strategy use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risky Behaviors | 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. |
| Change from Baseline Risky Behaviors at 2 weeks | Post-intervention (2 weeks) | Change in RBQ total and subscale scores, with reductions reflecting decreased engagement in risky behaviors. |
| Change from Baseline Risky Behaviors at 1 month | Follow-up (1 month) | Maintenance of reductions in risky behaviors. |
Countries
Romania
Contacts
Primary ContactOana David, Ph.D
Outcome results
None listed