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

Stress Clinical Trial

Official title:

Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05784831
• Other study ID #: UZH_ReApp
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: May 22, 2022

Study information

• Verified date: March 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 22, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

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.
• Ecological Momentary Assessment
The EMA tested here collects data on participants' mood and behavior.

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Johannes Gutenberg University Mainz, Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Switzerland, 

Outcome

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