FeelSync: Tailoring Ecological Momentary Assessments and Interventions for Emotion Awareness, Regulation, and Mental Health Outcomes (FeelSync)

May 22, 2025 updated by: Marta Marciniak
This study investigates how different ways of reflecting on emotions in daily life influence emotional awareness, emotion regulation, and mental health. Using the FeelSync mobile app over the course of seven days, participants are prompted multiple times a day to report on their current emotional state in various formats (e.g., rating scales, multiple choice, or free text). In some groups, participants also receive brief daily exercises designed to help them practice cognitive reappraisal-a strategy that involves reframing stressful situations to reduce their emotional impact. The study aims to assess not only the overall effectiveness of these reappraisal exercises but also whether the type of emotional self-report used before the intervention affects its impact. All participants complete questionnaires before and after the app phase to track changes in mood, stress, emotional awareness, and regulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
490

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus University Rotterdam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Owning a smartphone
  • Proficiency in English language
  • Being a student
  • Age between 18 to 30 years old

Exclusion Criteria:

- Severe mental health disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ecological Momentary Assessment with self-generated emotion description
Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in English, provided five times daily for seven consecutive days
Device: Ecological Momentary Assessment mobile application
Ecological Momentary Assessment used for self-monitoring of emotional states.
Active Comparator: Ecological Momentary Assessment with pre-defined set of emotion items to select
Ecological Momentary Assessment with pre-defined set of emotion items to select in a multiple-choice question form, in English, provided five times daily for seven consecutive days
Device: Ecological Momentary Assessment mobile application
Ecological Momentary Assessment used for self-monitoring of emotional states.
Active Comparator: Ecological Momentary Assessment with pre-defined set of emotion items to rate on a Likert scale
Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days
Device: Ecological Momentary Assessment mobile application
Ecological Momentary Assessment used for self-monitoring of emotional states.
Experimental: Ecological Momentary Intervention with self-generated emotion description
Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in English, provided five times daily for seven consecutive days
Device: FeelSync mobile application
Ecological Momentary Intervention focused on cognitive reappraisal for distressing autobiographical memories, with a possibility to choose between distancing and positive reappraisal.
Experimental: Ecological Momentary Intervention with self-generated emotion description in mother tongue
Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with participant's self-generated emotion description in an open-ended question form, in participant's mother tongue, provided five times daily for seven consecutive days
Device: FeelSync mobile application
Ecological Momentary Intervention focused on cognitive reappraisal for distressing autobiographical memories, with a possibility to choose between distancing and positive reappraisal.
Experimental: Ecological Momentary Intervention with pre-defined set of emotion items to select
Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days
Device: FeelSync mobile application
Ecological Momentary Intervention focused on cognitive reappraisal for distressing autobiographical memories, with a possibility to choose between distancing and positive reappraisal.
Experimental: Ecological Momentary Intervention with pre-defined set of emotion items to rate on a Likert scale
Ecological Momentary Intervention focused on cognitive reappraisal, with a possibility to choose between distancing and positive reappraisal, provided three times daily and preceded by Ecological Momentary Assessment with pre-defined set of emotion items to rate on a seven-point Likert scale, in a slider form, in English, provided five times daily for seven consecutive days
Device: FeelSync mobile application
Ecological Momentary Intervention focused on cognitive reappraisal for distressing autobiographical memories, with a possibility to choose between distancing and positive reappraisal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Self-report questionnaire, Range: 0 - 40 Higher scores: Worse outcome (higher perceived stress)
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Beck Depression Inventory II
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Self-report questionnaire, Range: 0 - 63 Higher scores: Worse outcome (more severe depressive symptoms)
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
State-Trait Anxiety Inventory
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Self-report questionnaire, [state scale only], Range: 20 - 80 Higher scores: Worse outcome (greater state anxiety)
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Emotion Regulation Questionnaire
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Self-report questionnaire, Reappraisal subscale: Range 1 - 7 (mean of 6 items) Higher scores: Better outcome (more frequent use of cognitive reappraisal) Suppression subscale: Range 1 - 7 (mean of 4 items) Higher scores: Worse outcome (more frequent use of suppression)
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Cognitive Emotion Regulation Questionnaire
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)

Self-report questionnaire, Subscale range: 2 - 10 per strategy

Higher scores:

On adaptive strategies (e.g., positive reappraisal, putting into perspective): Better outcome On maladaptive strategies (e.g., rumination, catastrophizing): Worse outcome
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Toronto Alexithymia Scale
Time Frame: Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)
Self-report questionnaire, Range: 20 - 100 Higher scores: Worse outcome (greater difficulties in identifying and describing feelings; lower emotional awareness)
Baseline (pre-intervention, study day 1) and Follow-up (post intervention, study day 9)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mobile Agnew Relationship Measure
Time Frame: Follow-up (post intervention, study day 9)
Self-report questionnaire, Range: 16-112 Higher scores: Better outcome (stronger perceived therapeutic alliance with the app/intervention)
Follow-up (post intervention, study day 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marta Marciniak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETH2425-0653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only anonymized data from the self-report questionnaires will be shared via Open Science Framework.

IPD Sharing Time Frame

09/2025-09/2035

IPD Sharing Access Criteria

Anyone will be able to access anonymized participant data from self-report questionnaires.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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