Control ConditionNCT05376059
How v. How and Why Nudges and Rewards
A study testing How Nudge, How and Why Nudge and Incentive in people with Control Condition and How Incentive Receive, run by University of Pennsylvania at 1 site in United States.
Trial summary
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: 1. control: this will be a group who will not receive any outreach 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Control Condition, How Incentive Receive, How Incentive Holdout
- What is being tested?
- How Nudge, How and Why Nudge and Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2022to 1 May 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wharton Marketing Department
Philadelphia, Pennsylvania, 19130
About this study
Official title: 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:
Read more
- 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).
Read the 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.
- 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.
- Conditions
- Control Condition, How Incentive Receive, How Incentive Holdout, How Incentive Ineligible, How and Why Incentive Receive, How and Why Incentive Holdout
- Being tested
- How Nudge, How and Why Nudge, Incentive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
How NudgeBehavioural
We will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment.
How and Why NudgeBehavioural
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.
IncentiveBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Participants in this group will not receive any oureach at all |
| How incentive receive | Experimental | 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). Receives: Behavioral: How Nudge; Behavioral: Incentive |
| How incentive holdout | Experimental | 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. Receives: Behavioral: How Nudge |
| How incentive ineligible | Experimental | 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. Receives: Behavioral: How Nudge |
| How and why incentive receive | Experimental | 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). Receives: Behavioral: How and Why Nudge; Behavioral: Incentive |
| How and why incentive holdout | Experimental | 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. Receives: Behavioral: How and Why Nudge |
| How and why incentive ineligible | Experimental | 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. Receives: Behavioral: How and Why Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microwebsite Visits 2 Weeks
Number of participants who visit the website to find a mental health appointment.
Measured: We will conduct all analyses at 2 weeks post mailer.
Microwebsite Visits 4 Weeks
Number of participants who visit the website to find a mental health appointment
Measured: We will conduct all analyses at 4 weeks post mailer.
Appointment Claims 3 Months
Number of participants who submit a claim for an appointment to the insurance company (indicating they did in fact make an appointment and go).
Measured: We will examine a claim for an appointment that was up to 3 months post mailer.
Appointment Claims 6 Months
Number of participants who submit a claim for an appointment to the insurance company (indicating they did in fact make an appointment and go).
Measured: We will examine a claim for an appointment that was up to 6 months post mailer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start24 Apr 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control ConditionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marissa Sharif, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376059
- Sponsor's protocol ID
- 850988
- Status last verified
- Jun 2023
- First submitted
- 2 May 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The company we are working with will be analyzing the data and informing us of the results. We will not have data to share.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of How v. How and Why Nudges and Rewards on Seeking Out Mental Health Treatment
- ClinicalTrials.gov ID
- NCT05376059
- Acronym / sponsor ID
- 850988
- Conditions
- Control Condition, How Incentive Receive, How Incentive Holdout, How Incentive Ineligible, How and Why Incentive Receive, How and Why Incentive Holdout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 24 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 17 May 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.
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).
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Participants in this group will not receive any oureach at all |
| How incentive receive | Experimental | Behavioral: How Nudge, Behavioral: IncentiveThis 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). |
| How incentive holdout | Experimental | Behavioral: How NudgeThis 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. |
| How incentive ineligible | Experimental | Behavioral: How NudgeThis 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. |
| How and why incentive receive | Experimental | Behavioral: How and Why Nudge, Behavioral: IncentiveThis 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). |
| How and why incentive holdout | Experimental | Behavioral: How and Why NudgeThis 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. |
| How and why incentive ineligible | Experimental | Behavioral: How and Why NudgeThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| How NudgeWe will nudge participants to get mental health treatment in a mailing that details how they can go about seeking treatment. | Behavioural | How incentive holdout, How incentive ineligible, How incentive receive |
| How and Why NudgeWe 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. | Behavioural | How and why incentive holdout, How and why incentive ineligible, How and why incentive receive |
| IncentiveParticipants 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). | Behavioural | How and why incentive receive, How incentive receive |
Primary outcome
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.
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
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).
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).
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 6 Jun 2023.
- Individual participant dataSharing planned: No. The company we are working with will be analyzing the data and informing us of the results. We will not have data to share.
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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.
Marissa Sharif, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing How Nudge, How and Why Nudge and Incentive in people with Control Condition and How Incentive Receive, run by University of Pennsylvania at 1 site in United States.
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 2 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 6 Jun 2023. 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 United States. 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?
Microwebsite Visits 2 Weeks (time frame: We will conduct all analyses at 2 weeks post mailer.). The study lists 4 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 6 Jun 2023.