Smoking
Conditions
Brief 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
Interventions
BEHAVIORALAcceptance Therapy (ACT)
ACT
OTHERCognitive Behavioral Therapy (CBT)
CBT
Sponsors
Consumer Wellness Solutions
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. aged 18 and older; 2. smokes at least 10 cigarettes daily and has done so for at least the past 12 months; 3. wants to quit smoking in the next 30 days; 4. willing to be randomly assigned to either group; 5. willing and able to speak and read in English; 6. willing and medically eligible to use nicotine replacement therapy (NRT), 7. currently resides in the U.S., and expects to continue for at least 12 months; 8. not participating in other smoking cessation interventions; 9. has regular access to a telephone. 10. has regular access to an email address.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Stopped Smoking by 6 Month Post Treatment | 6 months | 30-Day point prevalence abstinence at 6 months post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day and 24-hour Point Prevalence Quit Rates | 6-month | 7-day and 24-hour point prevalence quit rates |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acceptance & Commitment Therapy (ACT) ACT
Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone. | 59 |
| Cognitive Behavioral Therapy (CBT) CBT
Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone. | 62 |
| Total | 121 |
Baseline characteristics
| Characteristic | Acceptance & Commitment Therapy (ACT) | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 9.5 | 38.6 years STANDARD_DEVIATION 10.2 | 39.1 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 39 Participants | 45 Participants | 84 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 62 |
| serious Total, serious adverse events | 2 / 59 | 0 / 62 |
Outcome results
Primary
Number of Participants Who Stopped Smoking by 6 Month Post Treatment
30-Day point prevalence abstinence at 6 months post treatment
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acceptance & Commitment Therapy (ACT) | Number of Participants Who Stopped Smoking by 6 Month Post Treatment | 18 participants |
| Cognitive Behavioral Therapy (CBT) | Number of Participants Who Stopped Smoking by 6 Month Post Treatment | 14 participants |
Secondary
7-day and 24-hour Point Prevalence Quit Rates
7-day and 24-hour point prevalence quit rates
Time frame: 6-month