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

NCT05784831 | Completed

• 1 other identifier: UZH_ReApp
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

stress; health; resilience

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Regular Intervention Group

EXPERIMENTAL

Group using the app delivering reappraisal training for 21 consecutive days.

Device: Reappraisal training

Burst Intervention Group

EXPERIMENTAL

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

Active Control Group

ACTIVE COMPARATOR

Group using the ecological momentary assessment app for 21 consecutive days.

Device: Ecological Momentary Assessment

Interventions

Reappraisal training DEVICE

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.

Also known as: ReApp

Burst Intervention Group; Regular Intervention Group

Ecological Momentary Assessment DEVICE

The EMA tested here collects data on participants' mood and behavior.

Also known as: EMA

Active Control Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Johannes Gutenberg University Mainz: collaborator
• Radboud University Medical Center: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Psychiatric University Hospital Zurich

Zurich, 8032, Switzerland

Location

Study Officials

• Birgit Kleim, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: March 27, 2023
• Study Start: April 30, 2021
• Primary Completion: May 22, 2022
• Study Completion: May 22, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: from August 2022 onwards
• Access Criteria: open to everyone

Locations

CH (1)