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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT05623826
Collaborator
Johannes Gutenberg University Mainz (Other), Radboud University Medical Center (Other), Universitaire Ziekenhuizen KU Leuven (Other)
137
1
2
6.5
21.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive- behavioral imagery-based training
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel group design with control group completing only EMA, not EMIParallel group design with control group completing only EMA, not EMI
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants are informed of the two group design, individual group allocation is released to participants at the end of the study participation.
Primary Purpose:
Prevention
Official Title:
Feasibility and Efficacy of Imager, a Digital Training Intervention to Increase Reward Sensitivity: A Randomised Controlled Trial
Actual Study Start Date :
Sep 27, 2020
Actual Primary Completion Date :
Apr 13, 2021
Actual Study Completion Date :
Apr 13, 2021

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Behavioural avoidance/inhibition (BIS/BAS) scales [one week: Pre- to post-intervention/control]

      Self-reported reward sensitivity, scale range [0-15], higher score = worse outcome

    2. The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ) [one week: Pre- to post-intervention/control]

      Self-reported reward sensitivity, scale range [0-24], higher score = better outcome

    3. Perceived Stress Scale (PSS) [one week: Pre- to post-intervention/control]

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

    4. Beck Depression Inventory II (BDI-II) [one week: Pre- to post-intervention/control]

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

    5. State-Trait Anxiety Inventory (STAI) [one week: Pre- to post-intervention/control]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Psychiatric University Hospital Zürich Zurich Switzerland 8032

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT05623826
    Other Study ID Numbers:
    • UZH_Imager
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Zurich
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 21, 2022