Clinical trial NCT06609902: A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder
Official title: Future Self: An Episodic Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Tobacco Use Disorder
Keywords: bipolar disorder
comorbid tobacco use disorder
smoking cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Acceptability of the Study Intervention
timeFrame: Week: 6
measure: Feasibility of the Study Intervention
timeFrame: Week: 6
measure: Feasibility of the Study Intervention
timeFrame: Week: 6
Secondary outcomes:
measure: Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12)
timeFrame: Week: 1, 6, 10
measure: Participant Motivation to Quit Smoking
timeFrame: Week: 1, 6, 10
measure: Seeking Smoking Cessation Treatment as Assessed by The Seeking Smoking Cessation Treatment Questionnaire
timeFrame: Week: 1, 2, 3, 4, 5, 6, 10
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexandra K Gold, PhD
role: PRINCIPAL_INVESTIGATOR
References: