Future Thinking Intervention for Smoking and Bipolar Disorder

Overseen By Yousif Alsaadi, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Mood stabilizers

Disqualifiers: Psychosis, Suicidal intent, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist people with bipolar disorder (BD) who want to quit smoking through a new virtual method called the Future Self-BD Intervention. Participants will engage in six online sessions to envision positive future events that could improve by quitting smoking, alongside brief counseling. The trial compares this approach to another group receiving daily check-ins and similar counseling. It suits adults with BD who smoke at least five cigarettes daily, are stable on mood medications, and wish to quit smoking. As an unphased trial, this study provides a unique opportunity to explore innovative smoking cessation methods tailored to individuals with BD.

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.

What prior data suggests that this intervention is safe for participants with smoking and bipolar disorder?

Research has shown that the Future Self-BD program is an online tool designed to help people quit smoking by focusing on positive future events. As a form of behavioral therapy, it is typically easy to manage and does not involve medication, eliminating the risk of drug-related side effects.

The program consists of six online sessions where participants consider how quitting smoking could enhance their future. Conducted online, it offers convenience and safety. A professional leads the sessions, providing support and guidance throughout.

While specific studies on the safety of the Future Self-BD program are not available, similar behavioral therapies are generally safe and have been used successfully in other contexts. Participants can expect a supportive environment without the side effects associated with medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Future Self-BD technique for smoking cessation in individuals with bipolar disorder because it takes a novel, personalized approach. Unlike traditional methods that focus primarily on the immediate benefits of quitting smoking, Future Self-BD encourages participants to envision positive future events that could be enhanced by quitting, fostering a deeper, personal motivation. This intervention is coupled with virtual cognitive-behavioral therapy sessions, providing a comprehensive support system. By integrating vivid future thinking with established CBT techniques, researchers hope to unlock new pathways to successful long-term smoking cessation, especially tailored for those with bipolar disorder.

What evidence suggests that the Future Self-BD intervention might be an effective treatment for smoking and bipolar disorder?

This trial will compare two approaches for smoking cessation in individuals with bipolar disorder. Research has shown that thinking about the future can help people quit smoking by encouraging them to focus on positive events that could happen if they stop. Participants in the "Future Self-BD" arm will engage in sessions designed to vividly generate personal and positive future events that may benefit from smoking cessation. This method helps people imagine a better future, which can motivate them to quit. Meanwhile, the "Daily Check-Ins" arm will serve as an active comparator, where participants will receive similar counseling without the future-focused component. Studies have found that structured, evidence-based programs can be effective for people with bipolar disorder and other mental health issues. By concentrating on future benefits, like better health and well-being, the Future Self-BD approach may offer extra motivation for those dealing with both smoking and bipolar disorder. While detailed data on this specific method is still being gathered, it relies on proven psychological techniques that have succeeded in similar situations. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexandra K Gold, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 am on a consistent dose of medication for mood stabilization.

Diagnosis of tobacco use disorder

I am currently receiving treatment from a doctor outside of a hospital.

Exclusion Criteria

I have severe depression or hypomania symptoms.

Current psychosis

Intent to harm oneself with an associated plan and intent to act on suicidal thoughts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 6 virtual sessions of the Future Self-BD intervention or Daily Check-Ins, focusing on smoking cessation and future event visualization

6 weeks

6 visits (virtual)

Follow-up

Participants attend a follow-up session to assess outcomes and motivation to quit smoking

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Future Self-BD

Trial Overview

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.

How Is the Trial Designed?

Group I: Future Self-BD Experimental Treatment 1 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-Ins Active Control 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A pilot study involving 51 daily smokers with bipolar disorder tested a web-based smoking cessation program called WebQuit Plus, which is based on acceptance and commitment therapy (ACT), and showed promising acceptability and engagement compared to a standard program (Smokefree.gov).

At the end of the treatment, 12% of participants using WebQuit Plus achieved biochemically confirmed abstinence, compared to 8% in the Smokefree.gov group, indicating potential effectiveness of the ACT-based intervention, although further refinement and larger trials are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder. Heffner, JL., Kelly, MM., Waxmonsky, J., et al.[2021]

In a study of 336 outpatients with bipolar disorder, current smokers were found to have more severe manic symptoms, a longer duration of illness, and a higher prevalence of alcohol/substance use disorders compared to non-smokers.

The study revealed that while certain clinical factors are associated with being a smoker, the number of cigarettes smoked per day correlates with different variables, such as age and duration of illness, highlighting the complexity of smoking behavior in individuals with bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar disorder and tobacco smoking: Categorical and dimensional clinical correlates in subjects from the Brazilian bipolar research network. Medeiros, GC., Lafer, B., Kapczinski, F., et al.[2022]

A brief intervention for smokers with bipolar disorder (BD) significantly improved their readiness to quit smoking, with 30.9% of participants progressing in their 'Stage of Change' after the intervention.

Factors such as self-perceived cognitive performance, willingness to quit, and age significantly influenced the likelihood of improvement in readiness to change, highlighting the importance of addressing cognitive perceptions in smoking cessation efforts for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting the stage to quit smoking in Bipolar Disorder patients: brief advice in clinical practice. Sarramea, F., Jaen-Moreno, MJ., Balanzá-Martínez, V., et al.[2019]

In a study of 7,958 individuals with bipolar disorder (BD) and nicotine dependence (ND), it was found that each disorder can predict the onset of the other, indicating a complex relationship between them.

The majority of individuals had BD prior to developing ND, which was associated with an earlier onset of BD and more manic episodes, while those with ND prior had earlier daily smoking and a higher prevalence of alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal sequencing of nicotine dependence and bipolar disorder in the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Martínez-Ortega, JM., Goldstein, BI., Gutiérrez-Rojas, L., et al.[2021]

A study of 685 individuals with bipolar disorder revealed that 87% were current smokers, with 74% expressing a desire to quit smoking, indicating a strong interest in cessation despite the challenges they face.

Only 33% of smokers received advice to quit from mental health providers, highlighting a gap in support for smoking cessation among individuals with bipolar disorder, which could be addressed through online resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online survey of tobacco use, intentions to quit, and cessation strategies among people living with bipolar disorder. Prochaska, JJ., Reyes, RS., Schroeder, SA., et al.[2021]

Individuals with bipolar disorder have higher rates of tobacco smoking and lower smoking cessation success compared to the general population, highlighting a significant public health concern.

The review identified only one clinical trial focused on smoking cessation pharmacotherapy for this group, indicating a need for more targeted research and tailored treatment approaches for tobacco dependence in people with bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Smoking Cessation in Bipolar Disorder: Implications for Future Research. George, TP., Wu, BS., Weinberger, AH.[2021]

Citations

1.

massgeneral.trialstoday.org

massgeneral.trialstoday.org/trial/NCT06609902

Mass General - Division of Clinical Research

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that ...

2.

withpower.com

withpower.com/trial/phase-tobacco-use-disorder-9-2024-777da

Future Thinking Intervention for Smoking and Bipolar ...

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3729285/

The Co-occurrence of Cigarette Smoking and Bipolar Disorder

Smoking cessation is achievable for individuals with BD, but challenges such as chronic mood dysregulation, high prevalence of alcohol and drug use, more severe ...

4.

jneuropsychiatry.org

jneuropsychiatry.org/peer-review/effects-of-smoking-on-health-outcomes-in-bipolar-disorder-with-a-special-focus-on-suicidal-behavior-neuropsychiatry.pdf

effects-of-smoking-on-health-outcomes-in-bipolar-disorder- ...

Smoking/nicotine dependence is a highly comorbid condition in patients with BPD and it has a well-known role in the etiopathogenesis of cardiovascular disorders ...

5.

mental.jmir.org

mental.jmir.org/2025/1/e67670/

Digital Integrated Interventions for Comorbid Depression and ...

Structured, evidence-based approaches in face-to-face (F2F) settings have proven beneficial for treating major depressive disorder (MDD) and ...

6.

ichgcp.net

ichgcp.net/amp/clinical-trials-registry/NCT06609902

Future Self-BD and Daily Check-Ins in Tobacco Use Disorder and ...

Future Self-BD is a 6-session virtual intervention that encourages participants to vividly generate personal and positive future events that they anticipate ...

7.

cpn.or.kr

cpn.or.kr/journal/view.html?doi=10.9758/cpn.2015.13.1.1

Tobacco Use in Bipolar Disorder

Logistic regression found those with a history of tobacco smoking had approximately a three-fold increased risk of lifetime suicide attempt compared to those ...