Clinical trial NCT05784831: Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Increase Reappraisal.
Official title: Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Promote and Improve Stress Resilience, Specifically to Increase Reappraisal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: stress
health
resilience
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
name: Radboud University Medical Center
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2023-03-27
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: 21 days
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 21 days
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: 21 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 21 days
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Birgit Kleim, PhD
role: PRINCIPAL_INVESTIGATOR
References: