- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06883773
Digital Rewards and Retention in a M-health App (DIGITALRCT)
Does Engagement in a Computerized M-Health Intervention Increase With Digital Rewards?
Study Overview
Status
Intervention / Treatment
Detailed Description
Albeit effective, eHealth interventions suffer from very high dropout rates. Finding novel ways in which to maximise user retention and engagement in such settings can be beneficial, and exploring cryptocurrency as a potential reward may be worthwhile, since motivation seems to increase as the reward is perceived as more meaningful by the recipient.
The design is experimental, between-subjects, with one independent variable (the type of reward offered) and mental health (e.g., depression, anxiety, stress, and transdiagnostic constructs) as well as engagement and retention outcomes. Thus, three groups will be formed: two in which participants will be enrolled in the modular MOTO intervention and will receive different rewards, and one in which they will not receive any intervention or reward but will be evaluated as part of a waitlist control group. The modular MOTO intervention involves, in addition to the mentioned assessments, the completion of six weekly modules, each focused on specific aspects of mental health and containing exercises that may improve psychological well-being. These modules are automated, requiring no interaction with others (except for communication between participants and research team). Each of these modules contains the following: psychoeducational section(s) that participants must complete; a short test of 5-10 questions after each section to assess understanding of the material; (only for the first two groups); a link where they can obtain their rewards; the exercise corresponding to that module; the evaluation corresponding to that module.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cezar Giosan, PhD
- Phone Number: +40730908050
- Email: giosan@outlook.com
Study Locations
-
-
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Bucharest, Romania
- University of Bucharest
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Contact:
- Cezar Giosan, PhD
- Phone Number: +40730908050
- Email: giosan@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking
Exclusion Criteria:
-
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 |
|---|---|
|
Experimental: Crypto reward group
The participants will be enrolled in a weekly, 6 module intervention, which will require them to read psychoeducational materials, complete quizzes regarding those materials, complete the module-specific exercise, and then get rewarded in cryptocurrency.
The participants will be assessed before, during and after the intervention.
|
The intervention consists of 6 psychoeducational modules, on the Canvas teaching platform.
They are automated, requiring no interaction with others (except for communication between participants and the team).
Participants go through the psychoeducational modules, then do the corresponding exercise, and then access their rewards (if they belong to the experimental or comparative groups).
|
|
Active Comparator: Sweepstakes reward group
The participants will be enrolled in a weekly, 6 module intervention, which will require them to read psychoeducational materials, complete quizzes regarding those materials, complete the module-specific exercise, and then earn the chance to win vouchers for an online store.
The participants will be assessed before, during and after the intervention.
|
The intervention consists of 6 psychoeducational modules, on the Canvas teaching platform.
They are automated, requiring no interaction with others (except for communication between participants and the team).
Participants go through the psychoeducational modules, then do the corresponding exercise, and then access their rewards (if they belong to the experimental or comparative groups).
|
|
Other: Waitlist
The participants will be enrolled on the platform, but only for completing the assessments.
|
The participants will be assessed but without any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant retention
Time Frame: From enrollment to the end of the 6 week intervention
|
The numbers of participants that get to finish the entire intervention
|
From enrollment to the end of the 6 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User Engagement Scale - Short Version (UES-SF)
Time Frame: From the first module to the last (from week 1 to 6)
|
Score on how engaged the users feel while participating in the intervention - how satisfied and how much they value each intervention module. Minimum value = 1 Maximum value = 5 A higher score means a better outcome (i.e., a higher user engagement). |
From the first module to the last (from week 1 to 6)
|
|
The Depression, Anxiety and Stress Scale (DASS-21) - Depression
Time Frame: On week 1 and week 6 of the intervention
|
The users will be assessed to see if the intervention decreases depression symptoms. Minimum value = 0 Maximum value = 21 (raw score); please note that scores are usually doubled in order to maintain consistency with the DASS-42, which would result in a maximum of 42. Higher scores on this subscale are associated with a worse outcome (i.e. depression symptoms), and a total score can be compounded across all 3 subscales, after doubling their raw scores. This total score is a general psychological distress score. |
On week 1 and week 6 of the intervention
|
|
The Depression, Anxiety and Stress Scale (DASS-21) - Anxiety
Time Frame: On week 1 and week 6 of the intervention
|
The users will be assessed to see if the intervention decreases anxiety symptoms. Minimum value = 0 Maximum value = 21(raw score); please note that scores are usually doubled in order to maintain consistency with the DASS-42, which would result in a maximum of 42. Higher scores on this subscale are associated with a worse outcome (i.e. anxiety symptoms), and a total score can be compounded across all 3 subscales, after doubling their raw scores. This total score is a general psychological distress score. |
On week 1 and week 6 of the intervention
|
|
The Depression, Anxiety and Stress Scale (DASS-21) - Stress
Time Frame: On week 1 and week 6 of the intervention
|
The users will be assessed to see if the intervention decreases stress symptoms. Minimum value = 0 Maximum value = 21 (raw score); please note that scores are usually doubled in order to maintain consistency with the DASS-42, which would result in a maximum of 42. Higher scores on this subscale are associated with a worse outcome (i.e. stress symptoms), and a total score can be compounded across all 3 subscales, after doubling their raw scores. This total score is a general psychological distress score. |
On week 1 and week 6 of the intervention
|
|
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult
Time Frame: On week 1 and week 6 of the intervention
|
This is a DSM-5-TR screener for symptoms, to provide additional information beyond the other secondary measures. Minimum score = 0 Maximum score = 8 (depression, mania, somatic symptoms, psychosis, repetitive thoughts and behaviors, personality functioning); 4 (anger, suicidal ideation, sleep problems, memory, dissociation); 12 (anxiety, substance use). A rating of mild (i.e., 2) or greater on any item within a domain (except for substance use, suicidal ideation, and psychosis) may serve as a guide for additional inquiry and follow up to determine if a more detailed assessment for that domain is necessary. For substance use, suicidal ideation, and psychosis, a rating of slight (i.e., 1) or greater on any item within the domain may serve as a guide for additional inquiry and follow-up to determine if a more detailed assessment is needed. A greater score is associated with a worse outcome. |
On week 1 and week 6 of the intervention
|
|
The Intolerance of Uncertainty Scale: Short Version (IUS-12)
Time Frame: On week 1 and week 6 of the intervention
|
This is a transdiagnostic mental health factor that describes an individual's distress and ability to negatively perceive uncertainty as a whole. Minimum score = 12 Maximum score = 60 A greater score is associated with a worse outcome (i.e., more intense intolerance of uncertainty) |
On week 1 and week 6 of the intervention
|
|
The Difficulties in Emotion Regulation Scale: Brief Version (DERS-16)
Time Frame: On week 1 and week 6 of the intervention
|
This is a transdiagnostic factor that describes a person's management and control of emotional states. Minimum score = 16 Maximum score = 80 A greater score is associated with a worse outcome (i.e., more difficulty in reglating emotions) |
On week 1 and week 6 of the intervention
|
|
Ruminative Response Scale (RRS-10)
Time Frame: On week 1 and week 6 of the intervention
|
This is a transdiagnostic factor that describes a person's tendency to continually focus on negative emotions, experiences and thoughts. Minimum score = 10 Maximum score = 40 A higher score is associated with a worse outcome (i.e., more intense ruminations) |
On week 1 and week 6 of the intervention
|
|
Automatic Thoughts Questionnaire (Short Version) - ATQ -8
Time Frame: On week 1 and week 6 of the intervention
|
This is a transdiagnostic contruct that describes thoughts that occur spontaneously, triggered either by external or internal states of events. Minimum score = 8 Maximum score = 40 A higher score is associated with a worse outcome (i.e., greater frequency of negative automatic thoughts) |
On week 1 and week 6 of the intervention
|
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The Cognitive Fusion Questionnaire (CFQ-7)
Time Frame: On week 1 and week 6 of the intervention
|
This is a transdiagnostic construct that measures how much people get entangled and immersed in their thoughts and beliefs. Minimum score = 7 Maximum score = 49 A higher score is associated with a worse outcome (i.e., a stronger tendency towards cognitive fusion, becoming more entangled with one's own internal experiences and thoughts) |
On week 1 and week 6 of the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIGITALGAMINGRCT
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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