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Active (not recruiting) Not applicable NCT06609902

A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

No applicable phase (e.g. observational)
Conditions: Bipolar Disorder Tobacco Use Disorder

Sponsor: Massachusetts General Hospital

trial.available_in: БГ
Overview
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).
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.
Who can participate
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)
Interventions
Future Self-BD
BEHAVIORAL
Daily Check-Ins
BEHAVIORAL
Locations 1
United States (1)
Massachusetts General Hospital
Boston , Massachusetts
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.12.2024
Completion date
30.04.2028
Registry ID
NCT06609902
Source
clinicaltrials.gov
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