Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder

Study Overview
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Brief Summary
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This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.

Detailed Description
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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.

Official Title
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Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder

Conditions
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Smoking, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Experimental plus Nicotine Replacement Therapy
* Behavioral: Control plus Nicotine Replacement Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental therapy<br> | Behavioral: Experimental plus Nicotine Replacement Therapy<br>* 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.<br>|
| Active Comparator: Control Therapy<br> | Behavioral: Control plus Nicotine Replacement Therapy<br>* Includes four in-person and four phone visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Number approached, screened, eligible, and consented; reasons for ineligibility or refusal | Week -1 (Visit 0) | 
| Recruitment | Number approached, screened, eligible, and consented; reasons for ineligibility or refusal | Week 0 (Visit 1) | 
| Completion of the experimental intervention | Completion of the core treatment program | Week 10 | 
| Retention in study | Percentage of participants in each arm completing outcome assessments at end of treatment visit | Week 10 | 
| Retention in study | Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit | Week 14 | 
| Treatment satisfaction | 12 item survey used in our prior work assessing satisfaction with the assigned treatment | Week 10 | 
| Treatment utilization | Server-recorded log-ins to the assigned treatment | Week 10 | 
| Change in acceptance of smoking triggers | Change in acceptance scores between baseline and end of treatment | Week 10 | 
| Change in commitment to quit | Change in commitment scores between baseline and end of treatment | Week 10 | 
| CO-confirmed 7-day point prevalence abstinence from cigarette smoking | Preliminary efficacy for smoking cessation | Weeks 10 | 
| CO-confirmed 7-day point prevalence abstinence from cigarette smoking | Preliminary efficacy for smoking cessation | Week 14 | 
| Change in bipolar disorder symptoms | Change in mania and depression scale scores | Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Acceptance & Commitment Therapy, Cognitive Behavioral Therapy, Bipolar Disorder