Future Self: An Episodic Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility of the Study Intervention
研究概览
简要总结
Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. Each session will be conducted on HIPAA-compliant Zoom and led by the PI (Dr. Gold).
详细描述
This is a treatment development study that begins with an open non-randomized pilot trial (N = 10) in which we will test the manual developed for Future Self-BD by assessing the acceptability and feasibility of Future Self-BD. After completion of the non-randomized pilot trial and subsequent revisions to the Future Self-BD manual, we will conduct a parallel randomized controlled trial comparing Future Self-BD (N = 30) to a control treatment, Daily Check-Ins (N = 30). Future Self-BD and Daily Check-Ins involve six, weekly, 1.5-2 hour sessions and one 1.5 hour follow-up session one month after completion of the sixth session; thus, participants will be enrolled in the study for a period of 10 weeks. Assessments will occur at all study sessions.
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
- •Adults aged 18 or older
- •Have a diagnosis of BD I or II
- •Have a diagnosis of tobacco use disorder
- •Be engaged in outpatient treatment with a medical provider
- •Be on a stable dose of a mood-stabilizing medication
- •Smoke an average of at least 5 cigarettes per day for the past 30 days at baseline (based on the Heaviness of Smoking Index(Heatherton et al., 1989))
- •Be interested in quitting smoking
- •Not currently or in the past 3 months be receiving smoking cessation treatment.
排除标准
- •Current psychosis
- •Intent to harm oneself with an associated plan and intent to act on suicidal thoughts
- •Experiencing severe symptoms of depression and/or hypomania that may warrant a higher level of care (a Patient Health Questionnaire-9 total score ≥ 20(Kroenke et al., 2001) and/or an Altman Self-Rating Mania Scale total score ≥ 6(Altman et al., 1997) will trigger further clinician evaluation)
研究组 & 干预措施
Future Self-BD
Experimental Arm utilizing the Future Self-BD Intervention.The Future Self group will attend 6 virtual sessions during which they will be encouraged to vividly generate personal and positive future events that they anticipate may be benefited by smoking cessation. All participants will complete the adjusting amount discounting task. All participants will also receive brief, CBT-based smoking cessation counseling. This group will involve one follow-up session one month after the sixth session. Each session will be conducted on HIPAA-compliant Zoom and led by the PI, Dr. Gold.
干预措施: Future Self-BD (Behavioral)
Daily Check-Ins
Active comparator arm utilizing Daily Check-Ins (DCI). The DCI group will attend 6 virtual sessions during which they will complete the adjusting amount discounting task and receive brief, CBT-based smoking cessation counseling (consistent with counseling received by Future Self-BD). This group will involve one follow-up session one month after the sixth session. Each session will be conducted on HIPAA-compliant Zoom and led by the PI, Dr. Gold.
干预措施: Daily Check-Ins (Behavioral)
结局指标
主要结局
Feasibility of the Study Intervention
时间窗: Week: 6
We will assess feasibility via the frequency of participants who attend session 6 (i.e., retention).
Acceptability of the Study Intervention
时间窗: Week: 6
The Client Satisfaction Questionnaire (CSQ-8) will be administered at the end of session 6 to assess intervention acceptability via participant satisfaction with the intervention, with higher scores reflecting more satisfaction
次要结局
- Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12)(Week: 1, 6, 10)
- Participant Motivation to Quit Smoking(Week: 1, 6, 10)
- Seeking Smoking Cessation Treatment as Assessed by The Seeking Smoking Cessation Treatment Questionnaire(Week: 1, 2, 3, 4, 5, 6, 10)
研究者
Alexandra K. Gold, PhD
Principal Investigator
Massachusetts General Hospital