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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress

Intervention / Treatment
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* Device: Reappraisal training
* Device: Ecological Momentary Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular Intervention Group<br>Group using the app delivering reappraisal training for 21 consecutive days. | Device: Reappraisal training<br>* 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.<br>* Other names: ReApp;|
| Experimental: Burst Intervention Group<br>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<br>* 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.<br>* Other names: ReApp;|
| Active Comparator: Active Control Group<br>Group using the ecological momentary assessment app for 21 consecutive days. | Device: Ecological Momentary Assessment<br>* The EMA tested here collects data on participants' mood and behavior.<br>* Other names: EMA;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, health, resilience