SmokingTALKNCT01525420

Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy

A study testing Acceptance Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Smoking, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking
What is being tested?: Acceptance Therapy (ACT) and Cognitive Behavioral Therapy (CBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

aged 18 and older;
smokes at least 10 cigarettes daily and has done so for at least the past 12 months;
wants to quit smoking in 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 nicotine replacement therapy (NRT),

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currently resides in the U.S., and expects to continue for at least 12 months;
not participating in other smoking cessation interventions;
has regular access to a telephone.
has regular access to an email address.

Who cannot join

The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:
another member of household enrolled in the study;
currently using medication or nicotine replacement products to help with quitting smoking;
currently using any non-cigarette tobacco products;
pregnant or breastfeeding;
had a heart attack in last 30 days;
within the last 6 months, diagnosed with angina, heart pain, or irregular heartbeat;
serious adverse reactions to nicotine patches including anaphylaxis and related symptoms such as hives, respiratory difficulty, and/or angioedema.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Research Center
Seattle, Washington, 19024

Other trials in United States

About this study

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

Implementation outcomes:

end of treatment and 6-month follow-up data retention rates;
intervention implementation quality;
number \& length of calls completed.

Comparison of each arm's implementation

Conditions: Smoking
Being tested: Acceptance Therapy (ACT), Cognitive Behavioral Therapy (CBT)
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acceptance Therapy (ACT)Behavioural
ACT
Cognitive Behavioral Therapy (CBT)Other
CBT

Study groups in NCT01525420
Study group	Role	What they receive
ACT	Experimental	ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone. Receives: Behavioral: Acceptance Therapy (ACT)
CBT	Active comparator	CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone. Receives: Other: Cognitive Behavioral Therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Stopped Smoking by 6 Month Post Treatment
30-Day point prevalence abstinence at 6 months post treatment
Measured: 6 months

Secondary outcomes (1)

7-day and 24-hour Point Prevalence Quit Rates
7-day and 24-hour point prevalence quit rates
Measured: 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Mar 2013

First posted3 Feb 2012 (estimated)
Study startMar 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525420
Sponsor's protocol ID: 7445
Acronym: TALK
Status last verified: May 2014
First submitted: 31 Jan 2012
Last updated: 26 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35420700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
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Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence

All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy
ClinicalTrials.gov ID: NCT01525420
Acronym / sponsor ID: TALK / 7445
Conditions: Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: Consumer Wellness Solutions
Study start: Mar 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 3 Feb 2012 (estimated)
Results: Posted 16 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Implementation outcomes:

end of treatment and 6-month follow-up data retention rates;
intervention implementation quality;
number \& length of calls completed.

Comparison of each arm's implementation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ACT	Experimental	Behavioral: Acceptance Therapy (ACT)ACT: This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.
CBT	Active comparator	Other: Cognitive Behavioral Therapy (CBT)CBT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

aged 18 and older;
smokes at least 10 cigarettes daily and has done so for at least the past 12 months;
wants to quit smoking in the next 30 days;
willing to be randomly assigned to either group;
willing and able to speak and read in English;

Key exclusion criteria (8 listed)

The Exclusion criteria are the opposite of the Inclusion criteria listed above. In addition, the following exclusion criteria also apply:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acceptance Therapy (ACT)ACT	Behavioural	ACT
Cognitive Behavioral Therapy (CBT)CBT	Other	CBT

Primary outcome

Number of Participants Who Stopped Smoking by 6 Month Post Treatment
Time frame: 6 months
30-Day point prevalence abstinence at 6 months post treatment

1 secondary outcome

7-day and 24-hour Point Prevalence Quit Rates
Time frame: 6-month

Results and safety

Results posted to the registry on 16 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acceptance & Commitment Therapy (ACT)	59	43
Cognitive Behavioral Therapy (CBT)	62	38

Primary outcome: Number of Participants Who Stopped Smoking by 6 Month Post Treatment

Time frame: 6 months. Number. Unit: participants

Measure	Acceptance & Commitment Therapy (ACT) n = 59	Cognitive Behavioral Therapy (CBT) n = 62
Value	18	14

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acceptance & Commitment Therapy (ACT)	2 of 59 (3.4%)	0 of 59 (0%)	Not reported
Cognitive Behavioral Therapy (CBT)	0 of 62 (0%)	0 of 62 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35420700Jackson 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.

Related trials for Smoking

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Smoking, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Stopped Smoking by 6 Month Post Treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01525420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.