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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05623826
Other study ID # UZH_Imager
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2020
Est. completion date April 13, 2021

Study information

Verified date November 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Development and feasibility test of an Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity.


Description:

Aim of the current project is to develop and test Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity. EMIs are mostly smartphone-based applications that deliver interventions to people as they go about in their daily lives. The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and a 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 feasibility and effects of the EMI on a change in (i) reward sensitivity, (ii) mental imagery, and (iii) indices of perceived stress. One hundred twenty healthy student participants, aged 18-29 will be included in the study. Participants will be screened first and included if they score 5 points or more on the Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales. This is necessary in order to avoid a ceiling effect. Then, participants will be randomly assigned to an experimental (reward sensitivity EMI) or two of the control conditions (control EMA or waitlist). The reward sensitivity EMI group will be taught about experiencing rewards in daily life and will be asked to apply the specific techniques to personal situations repeatedly. The control EMA group will use the same app consisting of Ecological Momentary Assessment only, and the waitlist group will not receive any mobile app. The training will last seven consecutive days and the app will send (i) 10 prompts per day to ask about the current mood of the user in control EMA and experimental groups and (ii) three prompts per day resulting in a total of 21 reward training sessions only in the experimental group. Participants will be able to use a special button triggering the intervention or EMA by themselves too. After one week, participants will return to the lab, fill in questionnaires and participate in behavioral tasks.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date April 13, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility Inclusion Criteria: - being a student - having sufficient knowledge of the German language - being a smartphone user - score of 5 points or more in Reward Sensitivity Subscale of Behavioral Avoidance/Inhibition (BIS/BAS) scales Exclusion Criteria: - having a mental illness or attending the psychotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive- behavioral imagery-based training
The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and a repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.

Locations

Country Name City State
Switzerland Psychiatric University Hospital Zürich Zurich

Sponsors (4)

Lead Sponsor Collaborator
University of Zurich Johannes Gutenberg University Mainz, Leuven University, Radboud University Medical Center

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioural avoidance/inhibition (BIS/BAS) scales Self-reported reward sensitivity, scale range [0-15], higher score = worse outcome one week: Pre- to post-intervention/control
Primary The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ) Self-reported reward sensitivity, scale range [0-24], higher score = better outcome one week: Pre- to post-intervention/control
Primary Perceived Stress Scale (PSS) Self-reported level of stress, scale range [0-40], higher score = worse outcome one week: Pre- to post-intervention/control
Primary Beck Depression Inventory II (BDI-II) Self-reported depressive symptoms, scale range [0-63], higher score = worse outcome one week: Pre- to post-intervention/control
Primary State-Trait Anxiety Inventory (STAI) Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome one week: Pre- to post-intervention/control
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