Bipolar Disorder, Tobacco Use Disorder
Conditions
Keywords
bipolar disorder, comorbid tobacco use disorder, smoking cessation
Brief 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.
Interventions
BEHAVIORALFuture 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.
BEHAVIORALDaily 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Study Intervention | 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 |
| Feasibility of the Study Intervention | Week: 6 | We will assess feasibility via the frequency of participants who attend session 6 (i.e., retention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy to Resist Smoking as Assessed by the Smoking Self-Efficacy Questionnaire(SEQ-12) | 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. |
| Participant Motivation to Quit Smoking | 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. |
| Seeking Smoking Cessation Treatment as Assessed by The Seeking Smoking Cessation Treatment Questionnaire | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexandra K Gold, PhD
Massachusetts General Hospital
Outcome results
None listed