~47 spots leftby Oct 2028

Future Thinking Intervention for Smoking and Bipolar Disorder

Recruiting in Palo Alto (17 mi)
Overseen ByAlexandra K Gold, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group

Trial Summary

What is the purpose of this trial?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).
What makes the Future Self-BD treatment unique for smoking and bipolar disorder?

The Future Self-BD treatment is unique because it focuses on future thinking, which may help individuals with bipolar disorder and tobacco use disorder by enhancing their motivation and readiness to quit smoking, unlike traditional pharmacotherapy or brief interventions that primarily address immediate cessation strategies.

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What data supports the effectiveness of the Future Thinking Intervention for Smoking and Bipolar Disorder treatment?

The research shows that smokers with bipolar disorder often struggle to quit, but interventions like acceptance and commitment therapy (ACT) have been explored for their potential to help. Additionally, brief interventions in mental health settings have been shown to improve readiness to quit smoking among people with bipolar disorder.

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Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of a mood-stabilizing medication, so you will not need to stop taking your current mood-stabilizing meds.

Eligibility Criteria

This trial is for individuals who struggle with both tobacco use and bipolar disorder. Participants should be willing to attend six virtual sessions via a secure Zoom platform, led by the study's principal investigator.

Inclusion Criteria

I have been diagnosed with Bipolar Disorder I or II.

Participant Groups

The intervention being tested is called Future Self-BD, which consists of six online sessions aimed at helping participants envision positive future events that could result from quitting smoking.
2Treatment groups
Experimental Treatment
Active Control
Group I: Future Self-BDExperimental Treatment1 Intervention
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.
Group II: Daily Check-InsActive Control1 Intervention
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.

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

References

An online survey of tobacco use, intentions to quit, and cessation strategies among people living with bipolar disorder. [2021]Tobacco use is prevalent among people living with bipolar disorder. We examined tobacco use, attempts to quit, and tobacco-related attitudes and intentions among 685 individuals with bipolar disorder who smoked ≥ 100 cigarettes in their lifetime.
A Review of Smoking Cessation in Bipolar Disorder: Implications for Future Research. [2021]Tobacco smoking is common in people with bipolar disorder, and rates of smoking cessation are lower than in the general population. A literature review found eleven clinical research publications on bipolar disorder and tobacco, including only one smoking cessation pharmacotherapy trial. This article will review these findings and discuss possible reasons for the high rates of tobacco addiction among persons with bipolar disorder, as well as specific vulnerability factors that may contribute to tobacco treatment failure. An approach to the clinical assessment and treatment of tobacco dependence is described for this sub-group of smokers. Finally, recommendations are made for planning future treatment studies in persons with bipolar disorder and nicotine dependence.
Temporal sequencing of nicotine dependence and bipolar disorder in the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). [2021]Bipolar disorder (BD) and nicotine dependence (ND) often co-occur. However, the mechanisms underlying this association remain unclear. We aimed to examine, for the first time in a national and representative sample, the magnitude and direction of the temporal relationship between BD and ND; and to compare, among individuals with lifetime ND and BD, the sociodemographic and clinical characteristics of individuals whose onset of ND preceded the onset of BD (ND-prior) with those whose onset of ND followed the onset of BD (BD-prior). The sample included individuals with lifetime BD type I or ND (n = 7958) from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC, n = 43093). Survival analyses and logistic regression models were computed to study the temporal association between ND and BD, and to compare ND-prior (n = 135) and BD-prior (n = 386) individuals. We found that ND predicted the onset of BD and BD also predicted the onset of ND. Furthermore, the risk of developing one disorder following the other one was greatest early in the course of illness. Most individuals with lifetime ND and BD were BD-prior (72.6%). BD-prior individuals had an earlier onset of BD and a higher number of manic episodes. By contrast, ND-prior individuals had an earlier onset of both daily smoking and ND, and an increased prevalence of alcohol use disorder. In conclusion, ND and BD predict the development of each other. The phenomenology and course of ND and BD varied significantly depending on which disorder had earlier onset.
Bipolar disorder and tobacco smoking: Categorical and dimensional clinical correlates in subjects from the Brazilian bipolar research network. [2022]People with bipolar disorder (BD) have high rates of smoking. However, the scientific literature examining the association between clinical outcomes in BD and tobacco smoking is still limited and there are conflicting results. The objective of the current study was to comprehensively investigate associations between BD and tobacco smoking in a large Brazilian sample.
Setting the stage to quit smoking in Bipolar Disorder patients: brief advice in clinical practice. [2019]Tobacco consumption is the main preventable factor of mortality in smokers with bipolar disorder (BD), and any possible solutions are often blocked by prejudices over desire, and the possibilities and risks for these patients in giving up tobacco consumption. Adults with BD were recruited at 8 Mental Health Centres. Smokers were evaluated before and after a brief intervention based on the 3 A's and classified into a 'Stage of Change' (SOC) and their 'Readiness to Change' (RTC). A multiple linear regression was used to analyze the progression in their RTC and the independent effect of different variables (pharmacological treatment, history of psychotic symptoms, current anxiety symptoms, willingness, self-perceived capacity to quit smoking and subjective perception of cognitive functioning). Of 212 stable patients diagnosed with BD, current smokers (n=101; 47.6%) were included in the intervention phase, and 80.2% completed it. At baseline, 75.2% were considering the idea of giving up smoking and, after the brief intervention, 30.9% of the patients progressed in their SOC. A significant increase in the level of RTC was observed (53.3 vs 59.3, P=0.019). Perception of cognitive performance (β=-0.35;P=0.002), the degree of willing to quit (β=0.32;P=0.008), self-perceived capacity to quit tobacco smoking (β=-0.30;P=0.012), the patient's age (β=-0.72;P=0.004), the age of onset of smoking (β=0.48;P=0.022) and years as a smoker (β=0.48;P=0.025) were all factors that significantly influenced the chances of improving after the short intervention. Smokers with BD consider the idea of quitting and a brief intervention developed in the every day mental health care setting improves the level of readiness. The neurocognitive dysfunction associated with BD may limit patients' readiness to quit smoking.
Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder. [2021]Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability.