Clinical trial NCT05623826: Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager
Official title: Feasibility and Efficacy of Imager, a Digital Training Intervention to Increase Reward Sensitivity: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: stress
health
resilience
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
name: Radboud University Medical Center
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-11-21
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group design with control group completing only EMA, not EMI
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavioural avoidance/inhibition (BIS/BAS) scales
timeFrame: one week: Pre- to post-intervention/control
measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ)
timeFrame: one week: Pre- to post-intervention/control
measure: Perceived Stress Scale (PSS)
timeFrame: one week: Pre- to post-intervention/control
measure: Beck Depression Inventory II (BDI-II)
timeFrame: one week: Pre- to post-intervention/control
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: one week: Pre- to post-intervention/control
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatric University Hospital
state: Zurich
Study officials:
affiliation: University of Zurich
name: Birgit Kleim, PhD
role: PRINCIPAL_INVESTIGATOR
References: