NCT01812278

Brief Summary

The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,637

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

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

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

March 24, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2016

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 31, 2020

Status Verified

December 1, 2019

Enrollment Period

2.6 years

First QC Date

March 14, 2013

Last Update Submit

July 29, 2020

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • 30-day point prevalence abstinence

    No smoking in the past 30 days, as reported 12 month post treatment.

    12 month post randomization

Secondary Outcomes (1)

  • 7-day, 24-hour, and 30-day point prevalence quit rates

    3 months, 6 months, and 12 months post treatment

Study Arms (2)

ACT

EXPERIMENTAL

Acceptance \& Commitment Therapy

Behavioral: ACT

CBT

ACTIVE COMPARATOR

Cognitive Behavioral Therapy

Behavioral: CBT

Interventions

ACTBEHAVIORAL
Also known as: Acceptance & Commitment Therapy
ACT
CBTBEHAVIORAL
Also known as: Cognitive Behavioral Therapy
CBT

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • smokes at least five cigarettes daily for at least past 12 months
  • wants to quit in next 30 days
  • willing to be randomly assigned to either group
  • resides in US
  • has at least weekly access to a high speed Internet connection and email
  • willing and able to read in English
  • not participating in other smoking cessation interventions (including our other intervention studies
  • has never used the Smokefree.gov website
  • willing to complete all three follow-up surveys
  • provide email, phone, and mailing address
  • provide contact information for two collaterals (e.g., relatives).
  • does not have family, friends, or other household members participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (6)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Santiago-Torres M, Kwon DM, Mull KE, Sullivan BM, Ahluwalia JS, Alexander AC, Nollen NL, Bricker JB. Efficacy of Web-Delivered Acceptance and Commitment Therapy (ACT) for Helping Black Adults Quit Smoking. J Racial Ethn Health Disparities. 2023 Dec;10(6):2816-2825. doi: 10.1007/s40615-022-01458-5. Epub 2022 Nov 21.

    PMID: 36414931DERIVED

  • Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

    PMID: 35420700DERIVED

  • Watson NL, Heffner JL, Mull KE, McClure JB, Bricker JB. Comparing Treatment Acceptability and 12-Month Cessation Rates in Response to Web-Based Smoking Interventions Among Smokers Who Do and Do Not Screen Positive for Affective Disorders: Secondary Analysis. J Med Internet Res. 2019 Jun 19;21(6):e13500. doi: 10.2196/13500.

    PMID: 31219052DERIVED

  • Watson NL, Mull KE, Heffner JL, McClure JB, Bricker JB. Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions. J Med Internet Res. 2018 Aug 24;20(8):e10351. doi: 10.2196/10351.

    PMID: 30143479DERIVED

  • Bricker JB, Sridharan V, Zhu Y, Mull KE, Heffner JL, Watson NL, McClure JB, Di C. Trajectories of 12-Month Usage Patterns for Two Smoking Cessation Websites: Exploring How Users Engage Over Time. J Med Internet Res. 2018 Apr 20;20(4):e10143. doi: 10.2196/10143.

    PMID: 29678799DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Acceptance and Commitment TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jonathan Bricker

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

March 24, 2014

Primary Completion

October 26, 2016

Study Completion

December 31, 2019

Last Updated

July 31, 2020

Record last verified: 2019-12

Locations

US(1)