Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Completion of the experimental intervention
研究概览
简要总结
This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental therapy
干预措施: Experimental plus Nicotine Replacement Therapy (Behavioral)
Control Therapy
干预措施: Control plus Nicotine Replacement Therapy (Behavioral)
结局指标
主要结局
Completion of the experimental intervention
时间窗: Week 10
Completion of the core treatment program
Change in acceptance of smoking triggers
时间窗: Week 10
Change in acceptance scores between baseline and end of treatment
Change in commitment to quit
时间窗: Week 10
Change in commitment scores between baseline and end of treatment
CO-confirmed 7-day point prevalence abstinence from cigarette smoking
时间窗: Week 14
Preliminary efficacy for smoking cessation
Treatment satisfaction
时间窗: Week 10
12 item survey used in our prior work assessing satisfaction with the assigned treatment
Treatment utilization
时间窗: Week 10
Server-recorded log-ins to the assigned treatment
Change in bipolar disorder symptoms
时间窗: Week 10
Change in mania and depression scale scores
Recruitment
时间窗: Week 0 (Visit 1)
Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Retention in study
时间窗: Week 14
Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit
次要结局
未报告次要终点