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Clinical Trials/NCT05784831
NCT05784831
Completed
Not Applicable

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

University of Zurich1 site in 1 country146 target enrollmentApril 30, 2021
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Zurich
Enrollment
146
Locations
1
Primary Endpoint
Perceived Stress Scale (PSS)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2021
End Date
May 22, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Perceived Stress Scale (PSS)

Time Frame: 21 days

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

State-Trait Anxiety Inventory (STAI)

Time Frame: 21 days

Self-reported anxiety symptoms, scale range \[20-80\], 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

Emotion Regulation Questionnaire (ERQ)

Time Frame: 21 days

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

Study Sites (1)

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