Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 8
- Primary Endpoint
- Completion of the experimental intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental therapy
Intervention: Experimental plus Nicotine Replacement Therapy (Behavioral)
Control Therapy
Intervention: Control plus Nicotine Replacement Therapy (Behavioral)
Outcomes
Primary Outcomes
Completion of the experimental intervention
Time Frame: Week 10
Completion of the core treatment program
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: Week 14
Preliminary efficacy for smoking cessation
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 bipolar disorder symptoms
Time Frame: Week 10
Change in mania and depression scale scores
Recruitment
Time Frame: Week 0 (Visit 1)
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Retention in study
Time Frame: Week 14
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Secondary Outcomes
No secondary outcomes reported