- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06986850
- Original Trial
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
490
Phase
- 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
- Name: Marta A Marciniak, Dr
- Phone Number: +31 10 754 5276
- Email: marciniak@essb.eur.nl
Study Locations
-
-
-
Rotterdam, Netherlands
- Recruiting
- Erasmus University Rotterdam
-
Contact:
- Marta A Marciniak, Dr
- Phone Number: +31 10 754 5276
- Email: marciniak@essb.eur.nl
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
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
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
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)
March 12, 2025
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
May 15, 2025
First Submitted That Met QC Criteria
May 22, 2025
First Posted (Actual)
May 23, 2025
Study Record Updates
Last Update Posted (Actual)
May 23, 2025
Last Update Submitted That Met QC Criteria
May 22, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID 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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