Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Increase Reappraisal.

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT05784831
Collaborator
Johannes Gutenberg University Mainz (Other), Radboud University Medical Center (Other), Universitaire Ziekenhuizen KU Leuven (Other)
146
1
3
12.7
11.5

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Reappraisal training
  • Device: Ecological Momentary Assessment
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.
Actual Study Start Date :
Apr 30, 2021
Actual Primary Completion Date :
May 22, 2022
Actual Study Completion Date :
May 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regular Intervention Group

Group using the app delivering reappraisal training for 21 consecutive days.

Device: Reappraisal training
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.
Other Names:
  • ReApp
  • Experimental: Burst Intervention Group

    Group using the app delivering reappraisal training for 7 consecutive days, then having 7 days break and again using the app 7 consecutive days.

    Device: Reappraisal training
    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.
    Other Names:
  • ReApp
  • Active Comparator: Active Control Group

    Group using the ecological momentary assessment app for 21 consecutive days.

    Device: Ecological Momentary Assessment
    The EMA tested here collects data on participants' mood and behavior.
    Other Names:
  • EMA
  • Outcome Measures

    Primary Outcome Measures

    1. Perceived Stress Scale (PSS) [21 days]

      Self-reported level of stress, scale range [0-40], higher score = worse outcome

    2. Beck Depression Inventory II (BDI-II) [21 days]

      Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome

    3. Cognitive Emotion Regulation Questionnaire (CERQ) [21 days]

      Self-reported reappraisal skills, scale range [5-20], higher score = better outcome

    4. State-Trait Anxiety Inventory (STAI) [21 days]

      Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome

    5. Emotion Regulation Questionnaire (ERQ) [21 days]

      Self-reported reappraisal use, scale range [6-42], higher score = better outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. being a student

    2. having sufficient knowledge of the German language

    3. being a smartphone user

    4. low results in a CERQ questionnaire (less than 13 points in the Positive Reappraisal subscale).

    Exclusion Criteria:

    (1) having a current mental illness reported in the screening process.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Psychiatric University Hospital Zurich Zurich Switzerland 8032

    Sponsors and Collaborators

    • University of Zurich
    • Johannes Gutenberg University Mainz
    • Radboud University Medical Center
    • Universitaire Ziekenhuizen KU Leuven

    Investigators

    • Principal Investigator: Birgit Kleim, PhD, University of Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT05784831
    Other Study ID Numbers:
    • UZH_ReApp
    First Posted:
    Mar 27, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Zurich

    Study Results

    No Results Posted as of Mar 27, 2023