SmokingWebQuit PlusNCT02750904
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
A study testing Experimental plus Nicotine Replacement Therapy in people with Smoking and Bipolar Disorder, run by Fred Hutchinson Cancer Center at 4 sites in United States.
Trial summary
This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Bipolar Disorder
- What is being tested?
- Experimental plus Nicotine Replacement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Apr 2017to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bedford VA Research Corp
Bedford, Massachusetts, 01730
Jefferson Center for Mental Health
Denver, Colorado, 80228
VA Central Western Massachusetts Healthcare System
Leeds, Massachusetts, 01503
Palo Alto Veterans Institute for Research
Palo Alto, California, 94304
About this study
This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.
Read the 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.
- Conditions
- Smoking, Bipolar Disorder
- Being tested
- Experimental plus Nicotine Replacement Therapy, Control plus Nicotine Replacement Therapy
- Keywords
- Smoking Cessation, Acceptance & Commitment Therapy, Cognitive Behavioral Therapy, Bipolar Disorder
- Medical subject headings
- Smoking, Bipolar Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental plus Nicotine Replacement TherapyBehavioural
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.
Control plus Nicotine Replacement TherapyBehavioural
Includes four in-person and four phone visits
| Study group | Role | What they receive |
|---|---|---|
| Experimental therapy | Experimental | Not described Receives: Behavioral: Experimental plus Nicotine Replacement Therapy |
| Control Therapy | Active comparator | Not described Receives: Behavioral: Control plus Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Measured: Week -1 (Visit 0)
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Measured: Week 0 (Visit 1)
Completion of the experimental intervention
Completion of the core treatment program
Measured: Week 10
Retention in study
Percentage of participants in each arm completing outcome assessments at end of treatment visit
Measured: Week 10
Retention in study
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Measured: Week 14
Treatment satisfaction
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Measured: Week 10
Treatment utilization
Server-recorded log-ins to the assigned treatment
Measured: Week 10
Change in acceptance of smoking triggers
Change in acceptance scores between baseline and end of treatment
Measured: Week 10
Change in commitment to quit
Change in commitment scores between baseline and end of treatment
Measured: Week 10
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
Measured: Weeks 10
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
Measured: Week 14
Change in bipolar disorder symptoms
Change in mania and depression scale scores
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start3 Apr 2017
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Alto Veterans Institute for Research, Bedford Research Corporation, Inc., Jefferson Center, Community Mental Health Clinic, VA Central Western Massachusetts Healthcare System
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, Ph.D., Principal investigator, Fred Hutchinson Cancer Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750904
- Sponsor's protocol ID
- IR File# 8363
- Acronym
- WebQuit Plus
- Status last verified
- Oct 2019
- First submitted
- 24 Mar 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02750904
- Acronym / sponsor ID
- WebQuit Plus / IR File# 8363
- Conditions
- Smoking, Bipolar Disorder
- Keywords
- Smoking Cessation, Acceptance & Commitment Therapy, Cognitive Behavioral Therapy, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Palo Alto Veterans Institute for Research, Bedford Research Corporation, Inc., Jefferson Center, Community Mental Health Clinic, VA Central Western Massachusetts Healthcare System
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental therapy | Experimental | Behavioral: Experimental plus Nicotine Replacement Therapy |
| Control Therapy | Active comparator | Behavioral: Control plus Nicotine Replacement Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental plus Nicotine Replacement TherapyBehavioral: 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. | Behavioural | Experimental therapy |
| Control plus Nicotine Replacement TherapyIncludes four in-person and four phone visits | Behavioural | Control Therapy |
Primary outcome
Recruitment
Time frame: Week -1 (Visit 0)
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Recruitment
Time frame: Week 0 (Visit 1)
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Completion of the experimental intervention
Time frame: Week 10
Completion of the core treatment program
Retention in study
Time frame: Week 10
Percentage of participants in each arm completing outcome assessments at end of treatment visit
Retention in study
Time frame: Week 14
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Treatment satisfaction
Time frame: Week 10
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Treatment utilization
Time frame: Week 10
Server-recorded log-ins to the assigned treatment
Change in acceptance of smoking triggers
Time frame: Week 10
Change in acceptance scores between baseline and end of treatment
Change in commitment to quit
Time frame: Week 10
Change in commitment scores between baseline and end of treatment
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Time frame: Weeks 10
Preliminary efficacy for smoking cessation
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Time frame: Week 14
Preliminary efficacy for smoking cessation
Change in bipolar disorder symptoms
Time frame: Week 10
Change in mania and depression scale scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimee Heffner, Ph.D. principal investigator
Fred Hutchinson Cancer Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental plus Nicotine Replacement Therapy in people with Smoking and Bipolar Disorder, run by Fred Hutchinson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Week -1 (Visit 0)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.