Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Feasibility 3: Participant Attendance
研究概览
简要总结
Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
详细描述
The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.
We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.
The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified <8ppm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be between 18 - 70 years old
- •Must indicate willingness to make a quit attempt in the next 30 days
- •Must report being a daily cigarette smoker (including those labeled "little cigars") for past month
- •Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV)
- •Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks
- •Must have a smartphone, tablet, or computer with ability to download apps
- •Must currently receive mental health treatment
- •Must sign release of information for current mental health treatment providers
排除标准
- •Must not currently (in past 10 days) be taking varenicline (Chantix),
- •Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
- •Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
- •Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
- •Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
- •Must not have pending legal matters with potential to result in jail time
- •Must not be planning on moving outside local area in next 3-months
- •Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
- •Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)
研究组 & 干预措施
NRT + Persistence Targeted Smoking Cessation in SMI
Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.
干预措施: Persistence Targeted Smoking Cessation in SMI (PTSC-S) (Behavioral)
NRT + Persistence Targeted Smoking Cessation in SMI
Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Feasibility 3: Participant Attendance
时间窗: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Participants in the PTSC-S intervention will attend at least 60% of their sessions
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
时间窗: 3-months post quit date (approximately 4 months after baseline assessment)
We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
时间窗: 3-months post quit date (approximately 4 months after baseline assessment)
We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Acceptability 1: Participant Rating of Usefulness of Intervention
时间窗: 3-months post quit date (approximately 4-months after baseline assessment)
After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.
Acceptability 2: Participant Rating of Counseling Session Length
时间窗: 3-months post quit date (approximately 4 months after baseline assessment)
After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.
Feasibility 2: Missing/Unusable Data
时间窗: 3-months post quit date (approximately 4 months after baseline assessment)
We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.
次要结局
- Number of Participants With Prolonged Abstinence at at 3-month Followup(3-months post target quit date (approximately 4 months after baseline assessment))
- Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up(3-months post target quit date (approximately 4 months after baseline assessment))
- Number of Participants With Prolonged Abstinence at End-of-counseling(End-of-counseling (8 weeks))
- Task Persistence Scores(2 months after baseline assessment and 4 months after baseline assessment)
- Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling(End-of-counseling (8 weeks))
- Cigarettes Per Day(2 months after baseline assessment and 4 months after baseline assessment)
研究者
Marc L. Steinberg, Ph.D.
Professor of Psychiatry
Rutgers, The State University of New Jersey