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

Primary Purpose

Stress

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Cognitive- behavioral imagery-based training

About this trial

This is an interventional prevention trial for Stress focused on measuring stress, health, resilience

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Psychiatric University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Experimental (receiving EMA and Imager EMI)

Control (receiving EMA only)

Outcomes

Primary Outcome Measures

Behavioural avoidance/inhibition (BIS/BAS) scales

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

The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ)

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

Perceived Stress Scale (PSS)

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

Beck Depression Inventory II (BDI-II)

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

State-Trait Anxiety Inventory (STAI)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05623826

First Posted

April 25, 2022

Last Updated

November 13, 2022

Sponsor

University of Zurich

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05623826

Brief Title

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

Acronym

IMAGER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

September 27, 2020 (Actual)

Primary Completion Date

April 13, 2021 (Actual)

Study Completion Date

April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress

Keywords

stress, health, resilience

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel group design with control group completing only EMA, not EMI

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Experimental (receiving EMA and Imager EMI)

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control (receiving EMA only)

Intervention Type

Other

Intervention Name(s)

Cognitive- behavioral imagery-based training

Other Intervention Name(s)

Imager

Intervention Description

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.

Primary Outcome Measure Information:

Title

Behavioural avoidance/inhibition (BIS/BAS) scales

Description

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

Time Frame