Smoking CessationPhase 1/2PATHNCT01533974
PATH Partnering to Achieve Tobacco-free Health
A Phase 1/2 study testing Acceptance & Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Smoking Cessation, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance \& Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Acceptance & Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2015
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 and older;
- smoke at least 10 cigarettes per day for every day in the past month;
- want to quit smoking in the next 30 days;
- are able to speak and read in English;
- are a GH member enrolled living in the greater Seattle area;
- are not currently participating in other smoking cessation interventions;
Show all 10Show fewer
- not currently using other nicotine products (e.g., smokeless tobacco)
- are willing to attend five 90-minute group intervention sessions and to receive NRT over the next 3 months;
- have no medical contraindications for NRT use (i.e., pregnant, breastfeeding, recent heart attack, or skin allergy preventing use of the patch, as assessed using the standard GH contraindication screening for NRT patch);
- no household member currently enrolled in the study
Who cannot join
- fails to meet the eligibility criteria above;
- has a significant cognitive or physical impairment (e.g., dementia, deafness) that would preclude full participation in the counseling sessions. This will be assessed both by self-report and by in-person assessment at the baseline enrollment appointment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)
The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance \& Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and delivered within a real world healthcare setting.
- Conditions
- Smoking Cessation
- Being tested
- Acceptance & Commitment Therapy (ACT), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance & Commitment Therapy (ACT)Other
We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
Cognitive Behavioral Therapy (CBT)Other
The control condition will be the current group-delivered CBT smoking cessation program at GH.
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. Receives: Other: Acceptance & Commitment Therapy (ACT) |
| CBT | Active comparator | Not described 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 12 Month Post Treatment
30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionJan 2015
- Study completionJan 2015
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 Smoking CessationStudies 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533974
- Sponsor's protocol ID
- IR7441
- Acronym
- PATH
- Status last verified
- May 2016
- First submitted
- 13 Feb 2012
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance & Commitment Therapy for Smoking Cessation (Aka PATH Study - Partnering to Achieve Tobacco-free Health)
- ClinicalTrials.gov ID
- NCT01533974
- Acronym / sponsor ID
- PATH / IR7441
- Conditions
- Smoking Cessation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Jun 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Posted 9 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this 5-year project is to capitalize on the strong theoretical and promising empirical evidence for Acceptance \& Commitment Therapy (ACT) as an intervention for smoking cessation by comparing the effectiveness of ACT against standard cognitive behavioral therapy (CBT) counseling when both are offered with nicotine replacement therapy (NRT) and delivered within a real world healthcare setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Other: Acceptance & Commitment Therapy (ACT)We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. |
| CBT | Active comparator | Other: Cognitive Behavioral Therapy (CBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged 18 and older;
- smoke at least 10 cigarettes per day for every day in the past month;
- want to quit smoking in the next 30 days;
- are able to speak and read in English;
- are a GH member enrolled living in the greater Seattle area;
Key exclusion criteria (2 listed)
- fails to meet the eligibility criteria above;
- has a significant cognitive or physical impairment (e.g., dementia, deafness) that would preclude full participation in the counseling sessions. This will be assessed both by self-report and by in-person assessment at the baseline enrollment appointment
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 & Commitment Therapy (ACT)We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. | Other | ACT |
| Cognitive Behavioral Therapy (CBT)The control condition will be the current group-delivered CBT smoking cessation program at GH. | Other | CBT |
Primary outcome
Number of Participants Who Stopped Smoking by 12 Month Post Treatment
Time frame: 12 months
30 day point prevalence abstinence at 12 months. Missing = smoking and self report.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- 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.
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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.
Jonathan Bricker principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acceptance & Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Smoking Cessation, 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 2 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 17 Jun 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2016). 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 12 Month Post Treatment (time frame: 12 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 NCT01533974, 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 17 Jun 2016.