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In It To Quit: Commitment Contracts for Smoking Cessation (I2Q)

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ClinicalTrials.gov Identifier: NCT02596061
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Innovations for Poverty Action
Yale University
Information provided by (Responsible Party):
Community Health Center, Inc.

Brief Summary:
This study aims to examine whether a combination of positive and negative commitment devices is effective at inducing long-term smoking cessation in smokers from a low-to-moderate income background. Investigators will randomly assign patients of a multi-site clinic in Connecticut to receive one or both of a succession of two commitment contracts. First, a two-month reward contract will pay participants for (a) engaging in clinic and web-based activities that support smoking cessation and (b) quitting smoking, as measured at period end. Second, a four-month deposit contract will invite participants to commit funds which they forfeit unless they abstain from smoking over the entire period. A random subset of participants will also have the option to pre-commit to the deposit contract at study enrollment. Reward payout and deposit recovery will be conditional on biochemical verification of self-reported abstinence. Investigators will conduct follow-up biochemical verification at 12 months to observe whether abstinence persists after removal of incentives. The primary outcome of interest will be continuous abstinence from smoking between months 2 and 12, i.e. biochemically verified abstinence at all three measurements. A short baseline and endline survey will also be administered to measure characteristics and outcomes related to smoking behavior.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Deposit Contract Other: Incentives Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In It To Quit: Commitment Contracts for Smoking Cessation
Study Start Date : November 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
These participants are made aware of all smoking cessation services offered by the clinic, for example group counseling or individual counseling, but are not offered any rewards for participating in these activities.
Experimental: Intervention-Rewards Only
Patients have access to a website where they can self-report smoking status, add virtual supporters, and submit journal entries. Patients receive incentives for completing these activities and for utilizing counseling services at the clinic. At the 2 mo. mark, these participants come to the clinic for a biochemical verification of their smoking status. Their rewards are contingent on successfully passing this verification test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
Other: Incentives
Patients receive incentives for completing smoking cessation activities.

Experimental: Intervention-Pre-Commitment
Patients have access to a website where they can self-report smoking status, add supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. At enrollment, patients are offered the chance to set aside some of their future rewards for a deposit contract that lasts for 4 mos. and starts 2 mos. after the rewards contract. If, at the end of 6 mos., the patients pass the second verification test, their rewards are returned to them. At the 2 mo. mark, patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
Behavioral: Deposit Contract
Contracts prompt patients to put money they have earned at stake on a commitment to remain smoke-free for a longer period of time.

Other: Incentives
Patients receive incentives for completing smoking cessation activities.

Experimental: Intervention-Commitment
Patients have access to a website where they can self-report smoking status, add virtual supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. After 2 mos., this group is offered the chance to set aside some of their rewards towards a deposit contract that lasts for 4 months. If, after the 4 mos., the patients pass the second cessation verification test, their rewards are returned to them. At the 2 mo. mark, these patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
Behavioral: Deposit Contract
Contracts prompt patients to put money they have earned at stake on a commitment to remain smoke-free for a longer period of time.

Other: Incentives
Patients receive incentives for completing smoking cessation activities.




Primary Outcome Measures :
  1. Change in smoking cessation rates [ Time Frame: 2, 6, and 12 months post-enrollment ]
    The primary outcome of interest will be continuous abstinence from smoking between months 2 and 12, i.e. biochemically verified abstinence at all three measurements (2, 6 and 12 months)


Secondary Outcome Measures :
  1. Process Participation Rates [ Time Frame: 2 months post-enrollment ]
    One secondary outcome will be rates of participation in the various activities promoted for aiding in smoking cessation i.e. counseling, journaling, medication usage.

  2. Uptake rates of commitment contracts [ Time Frame: 2 months post-enrollment ]
    The final secondary outcome will be the rates of acceptance of commitment contracts by patients offered these devices.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be Community Health Center, Inc. medical patients
  • Must have had a clinic visit within the previous 2 years
  • Daily smoker, with smoking status verified by self-reports in clinic medical records
  • Age 18 or over; 19 or over if pregnant
  • Has regular access to internet on computer or smartphone
  • Not currently enrolled in R2Q and, if formerly enrolled in R2Q, not assigned to the intervention group.
  • Speaks English and/or Spanish

Exclusion Criteria:

  • Illiterate patients that do not have someone who can assist them during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596061


Locations
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United States, Connecticut
Community Health Center, Inc.
Middletown, Connecticut, United States, 06457
Sponsors and Collaborators
Community Health Center, Inc.
Innovations for Poverty Action
Yale University
Investigators
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Principal Investigator: Daren Anderson, MD Vice President/Director of Weitzman Institute/Chief Quality Officer
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Responsible Party: Community Health Center, Inc.
ClinicalTrials.gov Identifier: NCT02596061    
Other Study ID Numbers: 1071
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018