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

NCT05623826 | Completed

• 1 other identifier: UZH_Imager
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Keywords

stress; health; resilience

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Perceived Stress Scale (PSS)

  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)

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

  one week: Pre- to post-intervention/control

• State-Trait Anxiety Inventory (STAI)

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

  one week: Pre- to post-intervention/control

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental (receiving EMA and Imager EMI)

Other: Cognitive- behavioral imagery-based training

Control

NO INTERVENTION

Control (receiving EMA only)

Interventions

Cognitive- behavioral imagery-based training OTHER

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.

Also known as: Imager

Experimental

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• having a mental illness or attending the psychotherapy

Sponsors & Collaborators

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

Study Sites (1)

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

• Birgit Kleim, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are informed of the two group design, individual group allocation is released to participants at the end of the study participation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group design with control group completing only EMA, not EMI

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: November 21, 2022
• Study Start: September 27, 2020
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: from June 2022 onwards
• Access Criteria: open to everyone

Locations

CH (1)