Testing Financial Incentive Interventions in Dyadic-Smoker Couples

January 22, 2025 updated by: Michelle R Vandellen, University of Georgia
The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. During this time, participants will complete a baseline session and a follow-up. Between these visits, all participants will have access to a voluntary brief cessation program (i.e., online psychoeducation created for this study using Beat the Pack materials and resources from NCI, NIH + Nicotine Replacement Therapy [NRT]). The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. In the ST condition, one member of each couple (i.e., the target) will receive monetary incentives; in the DT condition, both members of the couple will receive monetary incentives. This design allows for preliminary consideration of FITs in DSCs and tests whether FITs for both members of the dyad synergistically enhances outcomes.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30602
        • University of Georgia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

both members:

  • age of 18+
  • smoke 5+ combustible cigarettes/day
  • may not have participated in pilot study

Exclusion Criteria:

  • < 8th grade capacity to read/write in English
  • hospitalization in recent 6 months
  • current drug or alcohol use disorder
  • psychotic symptoms
  • medical exclusion for use of NRT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control (CTL)
Participants do not receive financial incentive intervention
Behavioral: Financial Incentives
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
Experimental: Single Target (ST)
One member of each dyadic-smoking couple will receive financial incentive intervention
Behavioral: Financial Incentives
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
Experimental: Dyadic Target (DT)
Both members of each dyadic-smoking couple will receive financial incentive intervention
Behavioral: Financial Incentives
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: Follow-up study session 3 months post-baseline session
Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically
Follow-up study session 3 months post-baseline session
Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples
Time Frame: Through study recruitment and study completion, an average of five months
Feasibility of financial incentives treatment in dyadic-smoker couples was assessed by number of individuals retained in study. Retention was separated by condition.
Through study recruitment and study completion, an average of five months
Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples
Time Frame: Through study recruitment and study completion, an average of five months
Participant subjective ratings of the benefits and costs of participating in the study. Tolerability was defined using eight items assessing the accessibility, benefits, and costs of the study scored on a 1 (strongly disagree) to 7 (strongly agree) scale. Tolerability scores were separated by target and partner and reported by condition.
Through study recruitment and study completion, an average of five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Georgia

Investigators

  • Principal Investigator: Michelle R vanDellen, PhD, University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCA241570A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with other researchers who request it.

IPD Sharing Time Frame

Undecided

IPD Sharing Access Criteria

Researchers must make request for data and materials to the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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