In It To Quit: Commitment Contracts for Smoking Cessation

NCT02596061 | Completed

• 1 other identifier: 1071
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Change in smoking cessation rates

  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)

  2, 6, and 12 months post-enrollment

Secondary Outcomes (2)

• Process Participation Rates

  2 months post-enrollment

• Uptake rates of commitment contracts

  2 months post-enrollment

Study Arms (4)

Control

NO INTERVENTION

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.

Intervention-Rewards Only

EXPERIMENTAL

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

Intervention-Pre-Commitment

EXPERIMENTAL

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; Other: Incentives

Intervention-Commitment

EXPERIMENTAL

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; Other: Incentives

Interventions

Deposit Contract BEHAVIORAL

Contracts prompt patients to put money they have earned at stake on a commitment to remain smoke-free for a longer period of time.

Intervention-Commitment; Intervention-Pre-Commitment

Incentives OTHER

Patients receive incentives for completing smoking cessation activities.

Intervention-Commitment; Intervention-Pre-Commitment; Intervention-Rewards Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Community Health Center, Inc.: lead
• Innovations for Poverty Action: collaborator
• Yale University: collaborator

Study Sites (1)

Community Health Center, Inc.

Middletown, Connecticut, 06457, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Fertility

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Daren Anderson, MD

  Vice President/Director of Weitzman Institute/Chief Quality Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: November 4, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

US (1)