This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
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.
Includes four in-person and four phone visits
Palo Alto Veterans Institute for Research
Palo Alto, California, United States
Jefferson Center for Mental Health
Denver, Colorado, United States
Bedford VA Research Corp
Bedford, Massachusetts, United States
VA Central Western Massachusetts Healthcare System
Leeds, Massachusetts, United States
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Time frame: Week -1 (Visit 0)
Recruitment
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Time frame: Week 0 (Visit 1)
Completion of the experimental intervention
Completion of the core treatment program
Time frame: Week 10
Retention in study
Percentage of participants in each arm completing outcome assessments at end of treatment visit
Time frame: Week 10
Retention in study
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
Time frame: Week 14
Treatment satisfaction
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Time frame: Week 10
Treatment utilization
Server-recorded log-ins to the assigned treatment
Time frame: Week 10
Change in acceptance of smoking triggers
Change in acceptance scores between baseline and end of treatment
Time frame: Week 10
Change in commitment to quit
Change in commitment scores between baseline and end of treatment
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Time frame: Week 10
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
Time frame: Weeks 10
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
Preliminary efficacy for smoking cessation
Time frame: Week 14
Change in bipolar disorder symptoms
Change in mania and depression scale scores
Time frame: Week 10