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Behavioral Intervention
Future Thinking Intervention for Smoking and Bipolar Disorder
N/A
Waitlist Available
Led By Alexandra K Gold, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of BD I or II
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week: 1, 2, 3, 4, 5, 6, 10
Awards & highlights
No Placebo-Only Group
Summary
This trial involves a 6-session online program called Future Self-BD that helps people imagine positive future events that can be improved by quitting smoking. The sessions will be held on a secure video platform and
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a behavioral therapy session conducted virtually, there are no direct medical side effects like those associated with medication or surgical treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Bipolar Disorder I or II.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week: 1, 2, 3, 4, 5, 6, 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week: 1, 2, 3, 4, 5, 6, 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility
Secondary study objectives
Participant Motivation to Quit Smoking
Seeking Smoking Cessation Treatment as Assessed by The Seeking Smoking Cessation Treatment Questionnaire
Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Future Self-BDExperimental Treatment1 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-InsActive Control1 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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,361 Total Patients Enrolled
20 Trials studying Tobacco Use Disorder
11,563 Patients Enrolled for Tobacco Use Disorder
Alexandra K Gold, PhDPrincipal InvestigatorMassachusetts General Hospital
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