- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05578755
Evaluation of a Novel Intervention Aimed at Instilling Future-oriented Mindsets and Behaviors Using a Smartphone Application and Immersive Virtual Reality
Study Overview
Status
Intervention / Treatment
Detailed Description
People with a short-term mindset tend be focused on the here-and-now and are inclined to disregard the more distant consequences of their actions. This often results in self-defeating behaviors, i.e., behaviors that provide immediate gains but that may simultaneously incur significant costs in the longer run (e.g., substance use, delinquency, overspending). In contrast, people who are more future-oriented typically balance the immediate gains against the longer-term consequences of their decisions and are more inclined to set goals for the future. The investigators are developing an intervention, FutureU, aiming to promote future-oriented mindsets and behaviors by strengthening people's identification with their 'future self'. The level of identification with the future self depends on the extent to which people are able to vividly imagine their future self (i.e., vividness), feel positively towards their future self (i.e., valence), and feel similar and connected to their future self (i.e., related). During the intervention, participants interact with their future self. This future self is developed on the basis of a digitally aged image of themselves. In order to present the visual representation of the participants' future self, the investigators implement the intervention via a smartphone application (app) and via immersive virtual reality (VR). The present study examines the current iteration of the FutureU intervention, which is developed within an ongoing research program. The findings of this study will be used to further develop and optimize the FutureU intervention.
In a three-armed Randomized Controlled Trial, the investigators will evaluate the FutureU intervention by examining 1) its effectiveness on both proximal and distal outcomes, 2) its working mechanisms, and 3) moderators of intervention effects. It is hypothesized that FutureU will increase participants' future-oriented mindsets and behaviors (e.g., increase future orientation, enhance goal achievement, and reduce self-defeating behaviors). There are no specific expectations regarding differences in effectiveness between the two implementation strategies (app vs. VR). Regarding the working mechanisms, the hypothesis is that intervention effects of FutureU are mediated by increases in future self-identification. Concerning moderators, the investigators will examine the moderating role of personality traits within an intervention context in an exploratory fashion. Furthermore, associations between usage patterns (e.g., length and frequency of use), engagement levels and intervention outcomes will be examined, and the goals set by the participants will be analyzed qualitatively and quantitatively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zuid-Holland
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Leiden, Zuid-Holland, Netherlands, 2333AK
- Leiden University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- First-year university student
- Dutch speaking
Exclusion Criteria:
- Epileptic symptoms (due to VR condition)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Smartphone-based intervention
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FutureU is based on the assumption that future orientation can be strengthened by increasing the extent to which people identify with their future self. People who identify more with their future self appear to be more inclined to make more altruistic choices favoring their future self and foregoing immediate gratification. The intervention provides psychoeducation and exposure to and interaction with the future self. Participants interact with a digitally aged version of themselves, i.e., their 'future self', using a smartphone application (app) or through immersive virtual reality (VR). The app consists of three week-long modules. Participants interact with the app on a daily basis for about 5 minutes a day for 21 consecutive days. The VR consists of three sessions, each lasting about 30 minutes. Each VR session is guided by a trained researcher. |
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Experimental: Virtual reality intervention
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FutureU is based on the assumption that future orientation can be strengthened by increasing the extent to which people identify with their future self. People who identify more with their future self appear to be more inclined to make more altruistic choices favoring their future self and foregoing immediate gratification. The intervention provides psychoeducation and exposure to and interaction with the future self. Participants interact with a digitally aged version of themselves, i.e., their 'future self', using a smartphone application (app) or through immersive virtual reality (VR). The app consists of three week-long modules. Participants interact with the app on a daily basis for about 5 minutes a day for 21 consecutive days. The VR consists of three sessions, each lasting about 30 minutes. Each VR session is guided by a trained researcher. |
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Active Comparator: Goal-setting control condition
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In the control condition participants set goals (as in the intervention conditions), but receive no further guidance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Future self-identification
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Future self-identification, that is, the degree to which people have a clear image of their future self and can identify with their future self, will be assessed with 8 items based on Hershfield et al. (2009) and Van Gelder et al. (2015).
These items measure the degree to which people can imagine their future self vividly (i.e., vividness), the level of positive feelings towards the future self (i.e., valence), and the extent to which people feel connected and similar to their future self (i.e., relatedness).
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Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Future Orientation
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Future orientation measuring time perspective, anticipation of future consequences, and planning ahead will be assessed with the Future orientation Scale (Steinberg et al., 2009) consisting of 15 items (α = .80).
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Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Consideration of future consequences
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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The degree to which people take immediate versus distant consequences into account in potential behaviors will be assessed with the Consideration of Future Consequences questionnaire (Bruderer Enzler, 2013; Strathman et al., 1994) consisting of 9 items.
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Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Self-defeating behavior
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Self-defeating behavior, that is, behaviors with immediate gains though long-term costs, will be measured with 15 items representing different self-defeating behaviors based on the measure of Van Gelder et al. (2015).
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Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Goal commitment
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Commitment to the goal participants set for the year will be measured using the Goal Commitment Questionnaire (Hollenbeck et al., 1989) which consists of 7 items (α = .71).
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Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Goal achievement
Time Frame: Assessed during the 3-week intervention.
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Weekly and monthly goal achievement will be assessed with 3 self-developed items measuring how often participants thought about their goal, worked towards their goal, and to what extend they achieved their goal.
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Assessed during the 3-week intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-efficacy
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Self-efficacy, that is, people's sense of competence to effectively deal with life stressors, will be measured with the General Self-efficacy Questionnaire (Schwarzer & Jerusalem, 1995) consisting of 10 items (range α = .75
- .91).
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Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Academic results
Time Frame: Up to 10 months after baseline
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Academic results, i.e., grade point average, will be requested from the university at the end of the academic year after participants' consent.
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Up to 10 months after baseline
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Impulsiveness
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Impulsiveness, indicated by lack of impulse control on planning, motor, and attention will be assessed with the Barratt Impulsiveness Scale short form (Spinella, 2007) consisting of 15 items (α = .79).
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Change from baseline to 6-months follow-up (assessed at baseline, 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thinking about the future
Time Frame: Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
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We will ask participants how often in the past week they thought about their future and their future self (2 items).
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Change from baseline to 6-months follow-up (assessed at baseline, 1 and 2 weeks after baseline (i.e., during the intervention), 3 weeks after baseline (i.e., post measurement), and 3- and 6-months follow-up)
|
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Personality
Time Frame: Assessed at baseline and 6-months follow-up.
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Personality will be measured with the Dutch version of the 60-item HEXACO-PI-R (Lee & Asthon, 2018).
This questionnaire measures 6 personality dimensions: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness, and Openness to Experience.
Dimensions are assessed with 10 items each (range α = .82
- .89).
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Assessed at baseline and 6-months follow-up.
|
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Users' engagement and log data of the smartphone application
Time Frame: Assessed during the 3-week intervention.
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In the FutureU app condition, we use the nine-item TWente Engagement with Ehealth Technologies Scale (TWEETS) to measure users' engagement with the app (range α = .86
- .87).
We measure engagement with the app's specific features (e.g., opinion regarding the avatar appearance, and specific modules) with self-developed items.
Participants' usage patterns are captured in the app its log-data (e.g., number of days the app was opened and time spent in the app).
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Assessed during the 3-week intervention.
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Users' engagement and log data of the FutureU immersive virtual reality
Time Frame: Assessed during the 3-week intervention.
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In the FutureU VR condition, we measure users' experiences within and of the VR (e.g., embodiment, presence, and appearance avatar) and participants' (objective) behavioral data in VR (e.g., total time spent in the VR environment, number of switches between avatars, what questions they ask their future self).
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Assessed during the 3-week intervention.
|
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Participants' goals
Time Frame: Assessed during the 3-week intervention.
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Qualitative assessment of the goals participants set at the start and during the intervention, measuring aspects such as goal specificity, goal difficulty, topic of the goal, and goal type.
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Assessed during the 3-week intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Louis van Gelder, Prof.dr.dr., Max Planck Institute for the Study of Crime, Security, and Law; Leiden University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 772911-CRIMETIME
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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