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

Future Self: An Episodic Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Use Disorder; Bipolar Disorder
• Intervention / Treatment: Behavioral: Future Self-BD; Behavioral: Daily Check-Ins

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Future Self-BD; 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.	Behavioral: Future Self-BD; 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.
Active Comparator: Daily Check-Ins; 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.	Behavioral: Daily Check-Ins; The Daily Check-Ins (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Study Intervention	The Client Satisfaction Questionnaire (CSQ-8) will be administered at the end of session 6 to assess intervention acceptability via participant satisfaction with the intervention, with higher scores reflecting more satisfaction	Week: 6
Feasibility of the Study Intervention	We will assess feasibility via the frequency of participants who attend session 6 (i.e., retention).	Week: 6
Feasibility of the Study Intervention	We will assess feasibility via the frequency of participants who complete greater than or equal to 75% of cue recalls (Future Self-BD) or open-ended questions (Daily Check-Ins) and coach-led sessions (i.e.,completion).	Week: 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12)	Participant self-efficacy to resist smoking will be assessed by the Smoking Self-Efficacy Questionnaire (SEQ-12) to assess how confident someone is that they will be able to resist smoking across various situations. It will be administered at sessions 1, 6, and follow-up.	Week: 1, 6, 10
Participant Motivation to Quit Smoking	Participant motivation to quit smoking will be assessed using a single item that asks participants to rate how motivated they are to quit smoking on a scale from 0 (not at all motivated) to 10 (extremely motivated). It will be administered at sessions 1, 6, and follow-up.	Week: 1, 6, 10
Seeking Smoking Cessation Treatment as Assessed by The Seeking Smoking Cessation Treatment Questionnaire	The Seeking Smoking Cessation Treatment Questionnaire will be administered at sessions 1-6 and follow-up. This questionnaire assesses whether participants sought smoking cessation treatment since the last session, the nature of this treatment (i.e., NRT), how they sought this treatment, and whether they are interested in receiving a referral for smoking cessation treatment at the day's session.	Week: 1, 2, 3, 4, 5, 6, 10

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Alexandra K Gold, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: bipolar disorder; smoking cessation; comorbid tobacco use disorder
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mood Disorders; Behavior; Health Behavior; Bipolar Disorder; Tobacco Use Disorder; Smoking Cessation
• Other Study ID Numbers: 2024P000546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No