Trial Outcomes & Findings for Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy (NCT NCT01525420)
NCT ID: NCT01525420
Last Updated: 2014-05-26
Results Overview
30-Day point prevalence abstinence at 6 months post treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
6 months
Results posted on
2014-05-26
Participant Flow
Participant milestones
| Measure |
Acceptance & Commitment Therapy (ACT)
ACT
Acceptance \& Commitment Therapy (ACT): ACT
This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.
|
Cognitive Behavioral Therapy (CBT)
CBT
Cognitive Behavioral Therapy (CBT): CBT
This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
62
|
|
Overall Study
COMPLETED
|
43
|
38
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy
Baseline characteristics by cohort
| Measure |
Acceptance & Commitment Therapy (ACT)
n=59 Participants
ACT
Acceptance \& Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone.
|
Cognitive Behavioral Therapy (CBT)
n=62 Participants
CBT
Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months30-Day point prevalence abstinence at 6 months post treatment
Outcome measures
| Measure |
Acceptance & Commitment Therapy (ACT)
n=59 Participants
ACT
Acceptance \& Commitment Therapy (ACT): ACT
|
Cognitive Behavioral Therapy (CBT)
n=62 Participants
CBT
Cognitive Behavioral Therapy (CBT): CBT
|
|---|---|---|
|
Number of Participants Who Stopped Smoking by 6 Month Post Treatment
|
18 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 6-month7-day and 24-hour point prevalence quit rates
Outcome measures
Outcome data not reported
Adverse Events
Acceptance & Commitment Therapy (ACT)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acceptance & Commitment Therapy (ACT)
n=59 participants at risk
ACT
Acceptance \& Commitment Therapy (ACT): ACT
|
Cognitive Behavioral Therapy (CBT)
n=62 participants at risk
CBT
Cognitive Behavioral Therapy (CBT): CBT
|
|---|---|---|
|
Social circumstances
No AE term known- see description
|
1.7%
1/59
|
0.00%
0/62
|
|
Social circumstances
No AE term known - see description
|
1.7%
1/59
|
0.00%
0/62
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place