StressNCT05784831
Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Increase Reappraisal.
A study testing Reappraisal training and Ecological Momentary Assessment in people with Stress, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the current project is to develop and test Ecological Momentary Interventions (EMIs) to promote and improve stress resilience, specifically, an EMI to increase positive reappraisal. EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Reappraisal training and Ecological Momentary Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2021to 22 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- being a student
- having sufficient knowledge of the German language
- being a smartphone user
- low results in a CERQ questionnaire (less than 13 points in the Positive Reappraisal subscale).
Who cannot join
- having a current mental illness reported in the screening process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.
The aim of the current project is to develop and test Ecological Momentary Interventions (EMIs) to promote and improve stress resilience, specifically, an EMI to increase positive reappraisal.
EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.
Read more
This study tests the efficacy of the EMI on a change in (i) reappraisal and (ii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be invited to the study. Participants will be screened and those who score below 13 points of reappraisal skills in a Cognitive Emotion Regulation Questionnaire, will be included in the study. This is necessary in order to avoid a ceiling effect on reappraisal skills, which may be high in students.
Then, the participants will be randomly assigned to experimental (reappraisal EMI in regular and burst design) and control conditions (control EMA) and fill in questionnaires. The reappraisal EMI groups will be taught reappraisal skills and will be asked to apply them to personal situations repeatedly. The control EMA group will have the same app consisting of Ecological Momentary Assessment only. The training will last 21 consecutive days and the app will send (i) 5 prompts per day to ask about the current mood of the user in control and both experimental groups and (ii) at least two prompts per day resulting in a total of min. 42 reappraisal training sessions in the regular experimental group or 28 reappraisal training sessions in the burst experimental group. What is more, every participant has the possibility to trigger the EMA or EMI anytime they wish to. After using the app, participants will fill in some questionnaires again. The whole study will be conducted remotely (Video calls and app use) to avoid unnecessary COVID-related risks for participants.
- Conditions
- Stress
- Being tested
- Reappraisal training, Ecological Momentary Assessment
- Keywords
- stress, health, resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reappraisal trainingDevice
Also called ReApp
The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.
Ecological Momentary AssessmentDevice
Also called EMA
The EMA tested here collects data on participants' mood and behavior.
| Study group | Role | What they receive |
|---|---|---|
| Regular Intervention Group | Experimental | Group using the app delivering reappraisal training for 21 consecutive days. Receives: Device: Reappraisal training |
| Burst Intervention Group | Experimental | Group using the app delivering reappraisal training for 7 consecutive days, then having 7 days break and again using the app 7 consecutive days. Receives: Device: Reappraisal training |
| Active Control Group | Active comparator | Group using the ecological momentary assessment app for 21 consecutive days. Receives: Device: Ecological Momentary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Self-reported level of stress, scale range [0-40], higher score = worse outcome
Measured: 21 days
Beck Depression Inventory II (BDI-II)
Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome
Measured: 21 days
Cognitive Emotion Regulation Questionnaire (CERQ)
Self-reported reappraisal skills, scale range [5-20], higher score = better outcome
Measured: 21 days
State-Trait Anxiety Inventory (STAI)
Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome
Measured: 21 days
Emotion Regulation Questionnaire (ERQ)
Self-reported reappraisal use, scale range [6-42], higher score = better outcome
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start30 Apr 2021
- Primary completion22 May 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Birgit Kleim, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784831
- Sponsor's protocol ID
- UZH_ReApp
- Status last verified
- Mar 2023
- First submitted
- 25 May 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: OSF
Publications
Marciniak MA, Yuen KSL, Kalisch R, Kleim B. Contextual factors influence effectiveness of cognitive reappraisal. Behav Res Ther. 2026 Jul;202:105046. doi: 10.1016/j.brat.2026.105046. Epub 2026 Apr 20.
PubMed 42066391
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.
- ClinicalTrials.gov ID
- NCT05784831
- Acronym / sponsor ID
- UZH_ReApp
- Conditions
- Stress
- Keywords
- stress, health, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 27 Mar 2023 (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.
The aim of the current project is to develop and test Ecological Momentary Interventions (EMIs) to promote and improve stress resilience, specifically, an EMI to increase positive reappraisal.
EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.
This study tests the efficacy of the EMI on a change in (i) reappraisal and (ii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be invited to the study. Participants will be screened and those who score below 13 points of reappraisal skills in a Cognitive Emotion Regulation Questionnaire, will be included in the study. This is necessary in order to avoid a ceiling effect on reappraisal skills, which may be high in students.
Then, the participants will be randomly assigned to experimental (reappraisal EMI in regular and burst design) and control conditions (control EMA) and fill in questionnaires. The reappraisal EMI groups will be taught reappraisal skills and will be asked to apply them to personal situations repeatedly. The control EMA group will have the same app consisting of Ecological Momentary Assessment only. The training will last 21 consecutive days and the app will send (i) 5 prompts per day to ask about the current mood of the user in control and both experimental groups and (ii) at least two prompts per day resulting in a total of min. 42 reappraisal training sessions in the regular experimental group or 28 reappraisal training sessions in the burst experimental group. What is more, every participant has the possibility to trigger the EMA or EMI anytime they wish to. After using the app, participants will fill in some questionnaires again. The whole study will be conducted remotely (Video calls and app use) to avoid unnecessary COVID-related risks for participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular Intervention Group | Experimental | Device: Reappraisal trainingGroup using the app delivering reappraisal training for 21 consecutive days. |
| Burst Intervention Group | Experimental | Device: Reappraisal trainingGroup using the app delivering reappraisal training for 7 consecutive days, then having 7 days break and again using the app 7 consecutive days. |
| Active Control Group | Active comparator | Device: Ecological Momentary AssessmentGroup using the ecological momentary assessment app for 21 consecutive days. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being a student
- having sufficient knowledge of the German language
- being a smartphone user
- low results in a CERQ questionnaire (less than 13 points in the Positive Reappraisal subscale).
Key exclusion criteria (1 listed)
- having a current mental illness reported in the screening process.
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 |
|---|---|---|
| Reappraisal trainingAlso: ReAppThe EMI developed and tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones. | Device | Burst Intervention Group, Regular Intervention Group |
| Ecological Momentary AssessmentAlso: EMAThe EMA tested here collects data on participants' mood and behavior. | Device | Active Control Group |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: 21 days
Self-reported level of stress, scale range [0-40], higher score = worse outcome
Beck Depression Inventory II (BDI-II)
Time frame: 21 days
Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: 21 days
Self-reported reappraisal skills, scale range [5-20], higher score = better outcome
State-Trait Anxiety Inventory (STAI)
Time frame: 21 days
Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome
Emotion Regulation Questionnaire (ERQ)
Time frame: 21 days
Self-reported reappraisal use, scale range [6-42], higher score = better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 42066391Marciniak MA, Yuen KSL, Kalisch R, Kleim B. Contextual factors influence effectiveness of cognitive reappraisal. Behav Res Ther. 2026 Jul;202:105046. doi: 10.1016/j.brat.2026.105046. Epub 2026 Apr 20.
- Individual participant dataSharing planned: Yes. OSF
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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. This study is not recruiting at the moment.
Birgit Kleim, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reappraisal training and Ecological Momentary Assessment in people with Stress, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: 21 days). The study lists 5 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 NCT05784831, which also lists 1 linked publication.
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 27 Mar 2023.