Virtual intervention to help people with bipolar disorder quit smoking
Future Self: An Episodic Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder
NA · Massachusetts General Hospital · NCT06609902
This study is testing a virtual program to help people with bipolar disorder quit smoking by helping them imagine the positive changes that could come from stopping.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06609902 on ClinicalTrials.gov |
What this trial studies
This intervention, called Future Self-BD, consists of six virtual sessions designed to help individuals with comorbid bipolar disorder and tobacco use disorder envision positive future outcomes that could result from quitting smoking. The study will first conduct a non-randomized pilot trial with 10 participants to assess the feasibility and acceptability of the intervention. Following this, a randomized controlled trial will compare the Future Self-BD intervention with a control treatment called Daily Check-Ins, involving a total of 60 participants over a 10-week period. Assessments will be conducted at each session to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a diagnosis of bipolar disorder and tobacco use disorder who are interested in quitting smoking.
Not a fit: Patients currently experiencing psychosis or severe depressive symptoms may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve smoking cessation rates among individuals with bipolar disorder.
How similar studies have performed: While there have been studies addressing smoking cessation in individuals with mental health disorders, this specific approach combining future thinking with bipolar disorder treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Alexandra K Gold, PhD — Massachusetts General Hospital
- Study coordinator: Yousif Alsaadi, B.S.
- Email: yalsaadi@mgb.org
- Phone: 6177260997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder, Tobacco Use Disorder, bipolar disorder, comorbid tobacco use disorder, smoking cessation