NCT04832360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

January 8, 2021

Results QC Date

September 21, 2023

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Control (CTL)

EXPERIMENTAL

Participants do not receive financial incentive intervention

Behavioral: Financial Incentives

Single Target (ST)

EXPERIMENTAL

One member of each dyadic-smoking couple will receive financial incentive intervention

Behavioral: Financial Incentives

Dyadic Target (DT)

EXPERIMENTAL

Both members of each dyadic-smoking couple will receive financial incentive intervention

Behavioral: Financial Incentives

Interventions

Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)

Control (CTL)Dyadic Target (DT)Single Target (ST)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

Related Publications (1)

  • 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 Jan 29:10.1037/hea0001573. doi: 10.1037/hea0001573. Online ahead of print.

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Michelle vanDellen
Organization
University of Georgia

Study Officials

  • Michelle R vanDellen, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

January 8, 2021

First Posted

April 5, 2021

Study Start

January 15, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data will be shared with other researchers who request it.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Undecided
Access Criteria
Researchers must make request for data and materials to the PI

Locations