- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05376059
How v. How and Why Nudges and Rewards
The Impact of How v. How and Why Nudges and Rewards on Seeking Out Mental Health Treatment
Members of CVS/Aetna will receive a direct mailing or receive no outreach at all.
Our design will be a 3-cell between-subjects design:
- control: this will be a group who will not receive any outreach
- how: this will be a group that will receive a mailer emphasizing only how to seek treatment for mental health issues
- how and why: this will be a mailer emphasizing both how to get help and why they should get help for mental health issues (i.e., listing out how mental health treatment can improve their lives).
Within the how and how and why conditions, participants will be further divided into two different groups:
- incentive ineligible
- incentive eligible
The incentive ineligible will receive the how or how and why mailer, depending on their condition.
For the incentive eligible, they will again further be divided into the following two groups:
- incentive holdout
- incentive receive Those randomized into the incentive holdout group will receive the how or how and why mailer, depending on their condition. Those randomized into the incentive receive group will receive one of those two mailers, but it will also include an incentive if they seek out mental health treatment (if they visit a therapist within 30 days, they will receive a gift card).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our primary dependent variables will be: 1) number of participants who visit the website to find a mental health appointment and 2) number of participants who submit a claim for an appointment to the insurance company (indicating they did in fact make an appointment and go).
For clicks to the website, we will conduct all analyses at 2 weeks and 4 weeks post mailer.
We will examine a claim for an appointment that was up to 3 months and up to 6 months post mailer. The company we are collaborating with has indicated that claims will appear about 2 months after the person takes an appointment. We will base these analyses on the date the appointment was taken.
We will conduct the same analyses for both of our DVs.
First, we will examine if there are any differences between the incentive receive and incentive holdout conditions depending on if they are in the how and how and why conditions. That is, we will examine if there is a 2(How vs. How and Why) x 2(Incentive vs. No Incentive) interaction. If there is no interaction, we will examine the main effects: How vs. How and Why and also incentive vs. no incentive.
If there is no main effect of incentive and no interaction with incentive condition, we will collapse across the two incentive eligible groups (hold out and receive) for all further analyses.
- We will then compare the collapsed incentive eligible groups for both the how and how and why conditions to each other and to the control condition.
- We will also compare the collapsed incentive eligible groups for both the how and how and why conditions to their respective incentive ineligible groups. If there is no significant difference, we will compare the collapsed how and how and why conditions to each other and to the control.
If there are differences, we will keep the two incentive eligible groups separate for all further analyses.
1. We will then run pairwise comparisons between the following seven groups:
- Control condition
- How incentive receive
- How incentive holdout
- How incentive ineligible
- How and why incentive receive
- How and why incentive holdout
- How and why incentive ineligible
We will run all these analyses as either t-tests/chi square tests or linear/logistic regressions. This will be up to the preferences of the company we are working with as they will be conducting the analyses for us.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19130
- Wharton Marketing Department
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant must be a health insurance customer with the company we are working with.
- All other eligibility criteria are determined by the company and not disclosed to us. They will pick a sample of 60,000 eligible customers for the study, with participants then being randomly assigned to treatments they qualify for.
Exclusion Criteria:
- To be eligible for the incentive receive and holdout conditions, a participant must live in a state that allows these incentives to be mailed out by the company.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Condition
Participants in this group will not receive any oureach at all
|
|
|
Experimental: How incentive receive
This will be a group that will receive a mailer emphasizing only how to seek treatment for mental health issues, including an incentive if they seek out mental health treatment (if they visit a therapist within 30 days, they will receive a gift card).
|
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment.
Participants in incentive groups will also receive a mailer that includes a an incentive to seek treatment (if they visit a therapist within 30 days, they will receive a gift card).
|
|
Experimental: How incentive holdout
This will be a group that will receive a mailer emphasizing only how to seek treatment for mental health issues.
This group is eligible for an incentive but not randomly assigned to it.
|
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment.
|
|
Experimental: How incentive ineligible
This will be a group that will receive a mailer emphasizing only how to seek treatment for mental health issues.
This group is not eligible for an incentive.
|
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment.
|
|
Experimental: How and why incentive receive
This will be a group that will receive a mailer emphasizing both how to get help and why they should get help for mental health issues (i.e., listing out how mental health treatment can improve their lives), including an incentive if they seek out mental health treatment (if they visit a therapist within 30 days, they will receive a gift card).
|
Participants in incentive groups will also receive a mailer that includes a an incentive to seek treatment (if they visit a therapist within 30 days, they will receive a gift card).
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment and why they should go about seeking treatment.
|
|
Experimental: How and why incentive holdout
This will be a group that will receive a mailer emphasizing both how to get help and why they should get help for mental health issues (i.e., listing out how mental health treatment can improve their lives).
This group is eligible for an incentive but not randomly assigned to it.
|
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment and why they should go about seeking treatment.
|
|
Experimental: How and why incentive ineligible
This will be a group that will receive a mailer emphasizing both how to get help and why they should get help for mental health issues (i.e., listing out how mental health treatment can improve their lives).
This group is not eligible for an incentive.
|
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment and why they should go about seeking treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microwebsite Visits 2 Weeks
Time Frame: We will conduct all analyses at 2 weeks post mailer.
|
Number of participants who visit the website to find a mental health appointment.
|
We will conduct all analyses at 2 weeks post mailer.
|
|
Microwebsite Visits 4 Weeks
Time Frame: We will conduct all analyses at 4 weeks post mailer.
|
Number of participants who visit the website to find a mental health appointment
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We will conduct all analyses at 4 weeks post mailer.
|
|
Appointment Claims 3 Months
Time Frame: We will examine a claim for an appointment that was up to 3 months post mailer.
|
Number of participants who submit a claim for an appointment to the insurance company (indicating they did in fact make an appointment and go).
|
We will examine a claim for an appointment that was up to 3 months post mailer.
|
|
Appointment Claims 6 Months
Time Frame: We will examine a claim for an appointment that was up to 6 months post mailer.
|
Number of participants who submit a claim for an appointment to the insurance company (indicating they did in fact make an appointment and go).
|
We will examine a claim for an appointment that was up to 6 months post mailer.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marissa Sharif, PhD, University of Pennsylvania
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
Other Study ID Numbers
- 850988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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