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

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.

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 Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Device: Reappraisal training; Device: Ecological Momentary Assessment

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • Psychiatric University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS)	Self-reported level of stress, scale range [0-40], higher score = worse outcome	21 days
Beck Depression Inventory II (BDI-II)	Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome	21 days
Cognitive Emotion Regulation Questionnaire (CERQ)	Self-reported reappraisal skills, scale range [5-20], higher score = better outcome	21 days
State-Trait Anxiety Inventory (STAI)	Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome	21 days
Emotion Regulation Questionnaire (ERQ)	Self-reported reappraisal use, scale range [6-42], higher score = better outcome	21 days

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Radboud University Medical Center; Universitaire Ziekenhuizen KU Leuven; Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Birgit Kleim, PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): May 22, 2022
• Study Completion (Actual): May 22, 2022

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: health; stress; resilience
• Other Study ID Numbers: UZH_ReApp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: OSF
• IPD Sharing Time Frame: from August 2022 onwards
• IPD Sharing Access Criteria: open to everyone
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No