N/A
N=121
Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01525420 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants Who Stopped Smoking by 6 Month Post Treatment — 18; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acceptance Therapy (ACT) (Behavioral); Cognitive Behavioral Therapy (CBT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Stopped Smoking by 6 Month Post Treatment |
18; 14 | — |
| SECONDARY 7-day and 24-hour Point Prevalence Quit Rates |
— | — |
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).
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
Eligibility Criteria
Inclusion Criteria
- 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),
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01525420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.