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Active Not RecruitingNCT06609902

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFuture Self-BDThe 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.
BEHAVIORALDaily Check-InsThe 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.

Timeline

Start date
2024-12-06
Primary completion
2028-04-30
Completion
2028-04-30
First posted
2024-09-24
Last updated
2026-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06609902. Inclusion in this directory is not an endorsement.