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NCT Number: NCT05784831

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

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.

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Key information

Conditions

Stress

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric University Hospital Zurich

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ReApp

Ecological Momentary Assessment

Device

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

Other names: EMA

Primary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: 21 days

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

  2. Beck Depression Inventory II (BDI-II)

    Time frame: 21 days

    Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome

  3. Cognitive Emotion Regulation Questionnaire (CERQ)

    Time frame: 21 days

    Self-reported reappraisal skills, scale range [5-20], higher score = better outcome

  4. State-Trait Anxiety Inventory (STAI)

    Time frame: 21 days

    Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome

  5. Emotion Regulation Questionnaire (ERQ)

    Time frame: 21 days

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Johannes Gutenberg University Mainz
  • Radboud University Medical Center
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2023
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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