Back to resultsWeb-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder (WebQuit Plus)
Primary Purpose
Smoking, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental plus Nicotine Replacement Therapy
Control plus Nicotine Replacement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring Smoking Cessation, Acceptance & Commitment Therapy, Cognitive Behavioral Therapy, Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm
- Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)
- Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria
- Willing to be randomly assigned to either treatment group
- Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer
- Willing and able to read in English
- Is under care of a clinician for the treatment of bipolar disorder
- Willing to authorize communication with the clinician regarding study participation and clinical deterioration
- Willing to use the nicotine patch to help quit smoking
Exclusion Criteria:
- Participating in other smoking cessation interventions
- Currently using any pharmacotherapies for smoking cessation
- Previous use of the Smokefree.gov website
- Meets DSM-V criteria for current mania
- Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score > 14)
- Current psychotic symptoms
- Psychiatric hospitalization within one month prior to enrollment
- Current suicidal or homicidal ideation
- Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
- Unstable medical condition
- Any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention
- Any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
- Employee or family member of the investigator or study center, or member of the same household as another research participant
Sites / Locations
- Palo Alto Veterans Institute for Research
- Jefferson Center for Mental Health
- Bedford VA Research Corp
- VA Central Western Massachusetts Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental therapy
Control Therapy
Arm Description
Outcomes
Primary Outcome Measures
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Completion of the experimental intervention
Completion of the core treatment program
Retention in study
Percentage of participants in each arm completing outcome assessments at end of treatment visit
Retention in study
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Treatment satisfaction
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Treatment utilization
Server-recorded log-ins to the assigned treatment
Change in acceptance of smoking triggers
Change in acceptance scores between baseline and end of treatment
Change in commitment to quit
Change in commitment scores between baseline and end of treatment
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
Change in bipolar disorder symptoms
Change in mania and depression scale scores
Secondary Outcome Measures
Full Information
NCT ID
NCT02750904
First Posted
March 24, 2016
Last Updated
October 10, 2019
Sponsor
Fred Hutchinson Cancer Center
Collaborators
Palo Alto Veterans Institute for Research, Bedford Research Corporation, Inc., Jefferson Center, Community Mental Health Clinic, VA Central Western Massachusetts Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT02750904
Brief Title
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Acronym
WebQuit Plus
Official Title
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
Palo Alto Veterans Institute for Research, Bedford Research Corporation, Inc., Jefferson Center, Community Mental Health Clinic, VA Central Western Massachusetts Healthcare System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.
Detailed Description
The study consist of two separate phases. Phase I consists of website usability testing. Investigators will collect feedback and incorporate the feedback into our website that is tailored for people with bipolar disorder. In Phase II investigators will be comparing quit rates of two groups both utilizing Nicotine Replacement Therapy and a website.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Bipolar Disorder
Keywords
Smoking Cessation, Acceptance & Commitment Therapy, Cognitive Behavioral Therapy, Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental therapy
Arm Type
Experimental
Arm Title
Control Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Experimental plus Nicotine Replacement Therapy
Intervention Description
Behavioral: Experimental plus Nicotine Replacement Therapy will be built to specifically address challenges of smoking cessation for individuals with bipolar disorder.
Includes four in person and four phone visits.
Therapy information is withheld to protect the integrity of the study.
Intervention Type
Behavioral
Intervention Name(s)
Control plus Nicotine Replacement Therapy
Intervention Description
Includes four in-person and four phone visits
Primary Outcome Measure Information:
Title
Recruitment
Description
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Time Frame
Week -1 (Visit 0)
Title
Recruitment
Description
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Time Frame
Week 0 (Visit 1)
Title
Completion of the experimental intervention
Description
Completion of the core treatment program
Time Frame
Week 10
Title
Retention in study
Description
Percentage of participants in each arm completing outcome assessments at end of treatment visit
Time Frame
Week 10
Title
Retention in study
Description
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Time Frame
Week 14
Title
Treatment satisfaction
Description
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Time Frame
Week 10
Title
Treatment utilization
Description
Server-recorded log-ins to the assigned treatment
Time Frame
Week 10
Title
Change in acceptance of smoking triggers
Description
Change in acceptance scores between baseline and end of treatment
Time Frame
Week 10
Title
Change in commitment to quit
Description
Change in commitment scores between baseline and end of treatment
Time Frame
Week 10
Title
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Description
Preliminary efficacy for smoking cessation
Time Frame
Weeks 10
Title
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Description
Preliminary efficacy for smoking cessation
Time Frame
Week 14
Title
Change in bipolar disorder symptoms
Description
Change in mania and depression scale scores
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm
Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)
Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria
Willing to be randomly assigned to either treatment group
Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer
Willing and able to read in English
Is under care of a clinician for the treatment of bipolar disorder
Willing to authorize communication with the clinician regarding study participation and clinical deterioration
Willing to use the nicotine patch to help quit smoking
Exclusion Criteria:
Participating in other smoking cessation interventions
Currently using any pharmacotherapies for smoking cessation
Previous use of the Smokefree.gov website
Meets DSM-V criteria for current mania
Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score > 14)
Current psychotic symptoms
Psychiatric hospitalization within one month prior to enrollment
Current suicidal or homicidal ideation
Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
Unstable medical condition
Any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention
Any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
Employee or family member of the investigator or study center, or member of the same household as another research participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner, Ph.D.
Organizational Affiliation
Fred Hutchinson Cancer Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Veterans Institute for Research
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Jefferson Center for Mental Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Bedford VA Research Corp
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
VA Central Western Massachusetts Healthcare System
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
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