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

April 16, 2026 updated by: Alexandra K. Gold, PhD, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of the Study Intervention
Time Frame: Week: 6
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
Time Frame: Week: 6
We will assess feasibility via the frequency of participants who attend session 6 (i.e., retention).
Week: 6
Feasibility of the Study Intervention
Time Frame: Week: 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12)
Time Frame: Week: 1, 6, 10
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
Time Frame: Week: 1, 6, 10
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
Time Frame: Week: 1, 2, 3, 4, 5, 6, 10
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra K Gold, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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