Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager (IMAGER)

November 13, 2022 updated by: University of Zurich

Feasibility and Efficacy of Imager, a Digital Training Intervention to Increase Reward Sensitivity: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8032
        • Psychiatric University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Experimental (receiving EMA and Imager EMI)
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.
Other Names:
  • Imager
No Intervention: Control
Control (receiving EMA only)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Radboud University Medical Center
Johannes Gutenberg University Mainz
Leuven University

Investigators

  • Principal Investigator: Birgit Kleim, PhD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2020

Primary Completion (Actual)

April 13, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZH_Imager

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Github, OSF

IPD Sharing Time Frame

from June 2022 onwards

IPD Sharing Access Criteria

open to everyone

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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