StressIMAGERNCT05623826
Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager
A study testing Cognitive- behavioral imagery-based training in people with Stress, run by University of Zurich at 1 site in Switzerland.
Trial summary
Development and feasibility test of an Ecological Momentary Intervention (EMI) - Imager, to promote and improve stress resilience, specifically to increase reward sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Cognitive- behavioral imagery-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Sep 2020to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- having a mental illness or attending the psychotherapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Hospital
Zurich, Canton of Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Cognitive- behavioral imagery-based training
- Keywords
- stress, health, resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive- behavioral imagery-based trainingOther
Also called Imager
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental (receiving EMA and Imager EMI) Receives: Other: Cognitive- behavioral imagery-based training |
| Control | No intervention | Control (receiving EMA only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural avoidance/inhibition (BIS/BAS) scales
Self-reported reward sensitivity, scale range [0-15], higher score = worse outcome
Measured: 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
Measured: one week: Pre- to post-intervention/control
Perceived Stress Scale (PSS)
Self-reported level of stress, scale range [0-40], higher score = worse outcome
Measured: 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
Measured: one week: Pre- to post-intervention/control
State-Trait Anxiety Inventory (STAI)
Self-reported anxiety symptoms, scale range [20-80], higher score = worse outcome
Measured: one week: Pre- to post-intervention/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start27 Sep 2020
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group design with control group completing only EMA, not EMI
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Birgit Kleim, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623826
- Sponsor's protocol ID
- UZH_Imager
- Acronym
- IMAGER
- Status last verified
- Nov 2022
- First submitted
- 25 Apr 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Github, OSF
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Imager, a Digital Training Intervention to Increase Reward Sensitivity: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05623826
- Acronym / sponsor ID
- IMAGER / UZH_Imager
- Conditions
- Stress
- Keywords
- stress, health, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group design with control group completing only EMA, not EMI
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Cognitive- behavioral imagery-based trainingExperimental (receiving EMA and Imager EMI) |
| Control | No intervention | –Control (receiving EMA only) |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- having a mental illness or attending the psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive- behavioral imagery-based trainingAlso: ImagerThe 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 | Experimental |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Yes. Github, OSF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Kleim, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive- behavioral imagery-based training in people with Stress, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural avoidance/inhibition (BIS/BAS) scales (time frame: one week: Pre- to post-intervention/control). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.