NCT02421991

Brief Summary

The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

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

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

November 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 21, 2020

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

April 16, 2015

Last Update Submit

January 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30 day point prevalence abstinence

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

    12 months

Study Arms (2)

TALK study group

EXPERIMENTAL

This is the experimental arm of the study. This includes 5 weekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study.

Behavioral: Telephone Delivered Intervention

TALK control group

ACTIVE COMPARATOR

This is the control arm of the study. This includes 5 weekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study.

Behavioral: Telephone Delivered Intervention

Interventions

TALK control groupTALK study group

Eligibility Criteria

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

You may qualify if:

  • ages 18 and older
  • smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
  • wants to quit smoking in the next 30 days
  • if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
  • willing to be randomly assigned to either group
  • willing and able to speak and read in English
  • willing and medically eligible to use NRT
  • resides in the U.S., and expects to continue for at least 12 months
  • not participating in other smoking cessation interventions (including our own intervention trials)
  • has regular access to a telephone.

You may not qualify if:

  • In addition we will exclude:
  • anyone who is pregnant or breast feeding
  • has had a heart attack in the past 30 days
  • has unstable angina
  • has evidence of arrhythmia in the past 6 months
  • has a history of severe skin reaction to adhesive patches.

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 (1)

  • 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.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jonathan B Bricker, Ph.D.

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

November 2, 2015

Primary Completion

August 8, 2018

Study Completion

December 31, 2019

Last Updated

January 21, 2020

Record last verified: 2019-11

Locations