Testing Financial Incentive Interventions in Dyadic-Smoker Couples
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Incentives
Sponsored by
About this trial
This is an interventional other trial for Nicotine Dependence
Eligibility Criteria
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
Sites / Locations
- University of Georgia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control (CTL)
Single Target (ST)
Dyadic Target (DT)
Arm Description
Participants do not receive financial incentive intervention
One member of each dyadic-smoking couple will receive financial incentive intervention
Both members of each dyadic-smoking couple will receive financial incentive intervention
Outcomes
Primary Outcome Measures
Smoking Abstinence
Percentage of participants who have quit smoking by the follow-up study cessation verified biochemically
Feasibility of Financial Incentives Treatment in Dyadic-smoker couples as assessed by number of dyads retained in study
Number of people who contact the study team; number of complete dyads prescreened; percentage of eligible dyads enrolled; percentage of enrolled dyads retained through follow-up; percentage enrolled participants who drop out due to study procedures/burden; subjective ratings of benefits and costs of participating in study
Secondary Outcome Measures
Full Information
NCT ID
NCT04832360
First Posted
January 8, 2021
Last Updated
October 31, 2022
Sponsor
University of Georgia
1. Study Identification
Unique Protocol Identification Number
NCT04832360
Brief Title
Testing Financial Incentive Interventions in Dyadic-Smoker Couples
Official Title
Testing Financial Incentive Interventions in Dyadic-Smoker Couples
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (CTL)
Arm Type
Experimental
Arm Description
Participants do not receive financial incentive intervention
Arm Title
Single Target (ST)
Arm Type
Experimental
Arm Description
One member of each dyadic-smoking couple will receive financial incentive intervention
Arm Title
Dyadic Target (DT)
Arm Type
Experimental
Arm Description
Both members of each dyadic-smoking couple will receive financial incentive intervention
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentives
Intervention Description
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
Primary Outcome Measure Information:
Title
Smoking Abstinence
Description
Percentage of participants who have quit smoking by the follow-up study cessation verified biochemically
Time Frame
Follow-up study session 3 months post-baseline session
Title
Feasibility of Financial Incentives Treatment in Dyadic-smoker couples as assessed by number of dyads retained in study
Description
Number of people who contact the study team; number of complete dyads prescreened; percentage of eligible dyads enrolled; percentage of enrolled dyads retained through follow-up; percentage enrolled participants who drop out due to study procedures/burden; subjective ratings of benefits and costs of participating in study
Time Frame
Through study recruitment and study completion, an average of five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle R vanDellen, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Testing Financial Incentive Interventions in Dyadic-Smoker Couples
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