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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (CTL) | Experimental | Participants do not receive financial incentive intervention |
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| Single Target (ST) | Experimental | One member of each dyadic-smoking couple will receive financial incentive intervention |
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| Dyadic Target (DT) | Experimental | Both members of each dyadic-smoking couple will receive financial incentive intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Incentives | Behavioral | Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | 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 | 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 | 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 |
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Inclusion Criteria:
both members:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle R vanDellen, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41609650 | Derived | Andrade FC, Shen Y, MacKillop JM, Beach SRH, vanDellen MR. Dyadic patterns of abstinence from smoking in dual-smoking couples enrolled in a pilot randomized clinical trial. Health Psychol. 2026 May;45(5):528-538. doi: 10.1037/hea0001573. Epub 2026 Jan 29. |
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Data will be shared with other researchers who request it.
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Researchers must make request for data and materials to the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Single Target (ST) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence | Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically | Posted | Number | Targets | Follow-up study session 3 months post-baseline session | Targets | Targets |
|
Adverse events were collected during study participation (3 months)
Adverse events were to be self-reported through email.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle vanDellen | University of Georgia | 706-542-8991 | mvd@uga.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2021 | Apr 14, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2020 | Jun 17, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
|
| Relationship Length | Mean | Standard Deviation | years |
|
| OG002 | 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) |
|
|
| 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. | Posted | Count of Participants | Participants | Through study recruitment and study completion, an average of five months |
|
|
|
| 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. | Targets and Partners were analyzed separately. Thus, the total number of participants is 2x the number of targets and partners. | Posted | Mean | 95% Confidence Interval | units on a scale | Through study recruitment and study completion, an average of five months |
|
|
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| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | 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) | 0 | 68 | 0 | 68 | 0 | 68 |
| EG002 | 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) | 0 | 64 | 0 | 64 | 0 | 64 |
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| Partner Tolerability |
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