Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating)NCT07304830
The Effects of the PsyPills App on Emotion Regulation and Risk Behaviors in Emerging Adults: A Randomized Clinical Trial
A study testing PsyPills and MoodWheel in people with Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating), run by Babes-Bolyai University at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating)
- What is being tested?
- PsyPills and MoodWheel
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosed psychiatric disorders
- Suicide risk (score ≥ 7 on the Suicidal Behaviors Questionnaire-Revised, SBQ-R)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Babes-Bolyai University
Cluj-Napoca, Cluj, 400015
Avalon, +105 40-264-434141, oanadavid@psychology.ro
About this study
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.
Read the 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.
- Being tested
- PsyPills, MoodWheel
- Medical subject headings
- Substance-Related Disorders, Self-Injurious Behavior, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsyPillsBehavioural
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.
MoodWheelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MoodWheel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Post-intervention (2 weeks)
Change from Baseline Difficulties in Emotion Regulation at 1 month
Maintenance of change in DERS total and subscale scores.
Measured: 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.
Measured: Baseline
Change from Baseline Cognitive Emotion Regulation Strategies at 2 weeks
Change in adaptive emotion regulation strategies (e.g., cognitive reappraisal, acceptance).
Measured: Post-intervention (2 weeks)
Change from Baseline Cognitive Emotion Regulation Strategies at 1 month
Maintenance of adaptive emotion regulation strategy use.
Measured: Follow-up (1 month)
Secondary outcomes (3)
Risky Behaviors
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.
Measured: Baseline
Change from Baseline Risky Behaviors at 2 weeks
Change in RBQ total and subscale scores, with reductions reflecting decreased engagement in risky behaviors.
Measured: Post-intervention (2 weeks)
Change from Baseline Risky Behaviors at 1 month
Maintenance of reductions in risky behaviors.
Measured: Follow-up (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oana David, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304830
- Sponsor's protocol ID
- PsyPills-Risk-Behaviors
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27581175Perte, A. & Miclea, Mircea. (2011). The standardization of the cognitive emotion regulation questionnaire (CERQ) on Romanian population. Cognition Brain and Behavior. 15. 111-130.
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the PsyPills App on Emotion Regulation and Risk Behaviors in Emerging Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07304830
- Acronym / sponsor ID
- PsyPills-Risk-Behaviors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PsyPills | Experimental | Behavioral: PsyPillsA 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 | Active comparator | Behavioral: MoodWheelThe 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed psychiatric disorders
- Suicide risk (score ≥ 7 on the Suicidal Behaviors Questionnaire-Revised, SBQ-R)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsyPillsA 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. | Behavioural | PsyPills |
| MoodWheelThe 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. | Behavioural | MoodWheel |
Primary outcome
Difficulties in Emotion Regulation
Time frame: 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
Time frame: 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
Time frame: Follow-up (1 month)
Maintenance of change in DERS total and subscale scores.
Cognitive Emotion Regulation Strategies
Time frame: 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
Time frame: 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
Time frame: Follow-up (1 month)
Maintenance of adaptive emotion regulation strategy use.
3 secondary outcomes
Risky Behaviors
Time frame: Baseline
Change from Baseline Risky Behaviors at 2 weeks
Time frame: Post-intervention (2 weeks)
Change from Baseline Risky Behaviors at 1 month
Time frame: Follow-up (1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 27581175Weiss 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.
- Results publicationPerte, A. & Miclea, Mircea. (2011). The standardization of the cognitive emotion regulation questionnaire (CERQ) on Romanian population. Cognition Brain and Behavior. 15. 111-130.
- Results publicationGratz, 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PsyPills and MoodWheel in people with Emotion Regulation Difficulties; Risky Behaviors (Substance Use, Risky Sexual Behavior, Self-harm, Aggression, Disordered Eating), run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oana David, Ph.D (+105 40-264-434141, oanadavid@psychology.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07304830, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.