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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT | Experimental | We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. |
|
| CBT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 30 day point prevalence abstinence at 12 months. Missing = smoking and self report. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bricker | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Cooperative | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35420700 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and Commitment Therapy (ACT) | We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. |
| FG001 | Cognitive Behavioral Therapy (CBT) | Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and Commitment Therapy (ACT) | We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Stopped Smoking by 12 Month Post Treatment | 30 day point prevalence abstinence at 12 months. Missing = smoking and self report. | Posted | Number | participants | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acceptance and Commitment Therapy (ACT) | We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disturbed Sleep | General disorders | Non-systematic Assessment | Vivid, strange, weird dreams; common side effect of NRT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan B. Bricker, Ph.D. | Fred Hutchinson Cancer Research Center | 206-667-5074 | jbricker@fredhutch.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive Behavioral Therapy (CBT) | Other | The control condition will be the current group-delivered CBT smoking cessation program at GH. |
|
| Cognitive Behavioral Therapy (CBT) |
Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 224 |
| 17 |
| 224 |
| EG001 | Cognitive Behavioral Therapy (CBT) | Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH. | 0 | 226 | 5 | 226 |
|
| Skin irritation | General disorders | Non-systematic Assessment | Burning, itching, rash at patch site; common side effect of NRT. |
|
| Muscle Ache | General disorders | Non-systematic Assessment | Muscle ache and soreness at patch site; common side effect of NRT patch. |
|
| Stomach and digestive issues | General disorders | Non-systematic Assessment | Indigestion, nausea, and upset stomach; common side effect of NRT patch. |
|
| Dry mouth | General disorders | Non-systematic Assessment | Dry mouth; common side effect of NRT patch. |
|
| Headache | General disorders | Non-systematic Assessment | Headache off and on for past week; probably related |
|
| MRSA infection | General disorders | Non-systematic Assessment | Participant was treated for a MRSA infection; not related. |
|
| Anxiety | General disorders | Non-systematic Assessment | Anxiety and difficulty concentrating when first using the patch; common side effect of patch |
|
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