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

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).

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

Research Team

Alexandra K Gold, PhD

Principal Investigator

Massachusetts General Hospital

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 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Review of Smoking Cessation in Bipolar Disorder: Implications for Future Research. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Temporal sequencing of nicotine dependence and bipolar disorder in the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Setting the stage to quit smoking in Bipolar Disorder patients: brief advice in clinical practice. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Bipolar disorder and tobacco smoking: Categorical and dimensional clinical correlates in subjects from the Brazilian bipolar research network. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

An online survey of tobacco use, intentions to quit, and cessation strategies among people living with bipolar disorder. [2021]