Nicotine Dependence
Conditions
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.
Interventions
BEHAVIORALFinancial Incentives
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
Sponsors
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | Follow-up study session 3 months post-baseline session | Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically |
| Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples | 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. |
| Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control (CTL) Participants do not receive financial incentive intervention
Financial Incentives: Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) | 58 |
| Single Target (ST) One member of each dyadic-smoking couple will receive financial incentive intervention
Financial Incentives: Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) | 68 |
| Dyadic Target (DT) Both members of each dyadic-smoking couple will receive financial incentive intervention
Financial Incentives: Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) | 64 |
| Total | 190 |
Baseline characteristics
| Characteristic | Control (CTL) | Single Target (ST) | Dyadic Target (DT) | Total |
|---|---|---|---|---|
| Age, Continuous | 41.67 years STANDARD_DEVIATION 10.42 | 43 years STANDARD_DEVIATION 10.9 | 42.4 years STANDARD_DEVIATION 10.5 | 42.4 years STANDARD_DEVIATION 10.57 |
| Education College/Technical School Graduate | 14 Participants | 23 Participants | 21 Participants | 58 Participants |
| Education Less than College Degree | 43 Participants | 41 Participants | 37 Participants | 121 Participants |
| Education Post-college Education | 1 Participants | 4 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 39 Participants | 40 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 45 Participants | 54 Participants | 47 Participants | 146 Participants |
| Region of Enrollment United States | 58 participants | 68 participants | 64 participants | 190 participants |
| Relationship Length | 7.86 years STANDARD_DEVIATION 8.48 | 7.44 years STANDARD_DEVIATION 7.31 | 8.91 years STANDARD_DEVIATION 8.65 | 8.06 years STANDARD_DEVIATION 8.12 |
| Sex: Female, Male Female | 30 Participants | 35 Participants | 34 Participants | 99 Participants |
| Sex: Female, Male Male | 28 Participants | 33 Participants | 30 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 68 | 0 / 64 |
| other Total, other adverse events | 0 / 58 | 0 / 68 | 0 / 64 |
| serious Total, serious adverse events | 0 / 58 | 0 / 68 | 0 / 64 |
Outcome results
Primary
Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples
Feasibility of financial incentives treatment in dyadic-smoker couples was assessed by number of individuals retained in study. Retention was separated by condition.
Time frame: Through study recruitment and study completion, an average of five months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (CTL) | Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples | 54 Participants |
| Single Target (ST) | Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples | 58 Participants |
| Dyadic Target (DT) | Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples | 58 Participants |
Primary
Smoking Abstinence
Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically
Time frame: Follow-up study session 3 months post-baseline session
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (CTL) | Smoking Abstinence | Targets Abstinent | 4 Targets |
| Control (CTL) | Smoking Abstinence | Targets Not Abstinent | 25 Targets |
| Single Target (ST) | Smoking Abstinence | Targets Not Abstinent | 18 Targets |
| Single Target (ST) | Smoking Abstinence | Targets Abstinent | 16 Targets |
| Dyadic Target (DT) | Smoking Abstinence | Targets Not Abstinent | 23 Targets |
| Dyadic Target (DT) | Smoking Abstinence | Targets Abstinent | 9 Targets |
Primary
Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples
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.
Time frame: Through study recruitment and study completion, an average of five months
Population: Targets and Partners were analyzed separately. Thus, the total number of participants is 2x the number of targets and partners.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control (CTL) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Target Tolerability | 4.99 units on a scale |
| Control (CTL) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Partner Tolerability | 4.99 units on a scale |
| Single Target (ST) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Target Tolerability | 5.22 units on a scale |
| Single Target (ST) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Partner Tolerability | 5.04 units on a scale |
| Dyadic Target (DT) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Target Tolerability | 4.99 units on a scale |
| Dyadic Target (DT) | Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples | Partner Tolerability | 5.00 units on a scale |