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| Name | Class |
|---|---|
| Palo Alto Veterans Institute for Research | OTHER |
| Bedford Research Corporation, Inc. | OTHER |
| Jefferson Center, Community Mental Health Clinic | UNKNOWN |
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This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.
The study consist of two separate phases. Phase I consists of website usability testing. Investigators will collect feedback and incorporate the feedback into our website that is tailored for people with bipolar disorder. In Phase II investigators will be comparing quit rates of two groups both utilizing Nicotine Replacement Therapy and a website.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental therapy | Experimental |
| |
| Control Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental plus Nicotine Replacement Therapy | Behavioral | Behavioral: Experimental plus Nicotine Replacement Therapy will be built to specifically address challenges of smoking cessation for individuals with bipolar disorder. Includes four in person and four phone visits. Therapy information is withheld to protect the integrity of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number approached, screened, eligible, and consented; reasons for ineligibility or refusal | Week -1 (Visit 0) |
| Recruitment | Number approached, screened, eligible, and consented; reasons for ineligibility or refusal | Week 0 (Visit 1) |
| Completion of the experimental intervention | Completion of the core treatment program | Week 10 |
| Retention in study | Percentage of participants in each arm completing outcome assessments at end of treatment visit | Week 10 |
| Retention in study | Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit | Week 14 |
| Treatment satisfaction | 12 item survey used in our prior work assessing satisfaction with the assigned treatment | Week 10 |
| Treatment utilization | Server-recorded log-ins to the assigned treatment | Week 10 |
| Change in acceptance of smoking triggers | Change in acceptance scores between baseline and end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner, Ph.D. | Fred Hutchinson Cancer Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Veterans Institute for Research | Palo Alto | California | 94304 | United States | ||
| Jefferson Center for Mental Health |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D001714 | Bipolar Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| VA Central Western Massachusetts Healthcare System |
| UNKNOWN |
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|
| Control plus Nicotine Replacement Therapy | Behavioral | Includes four in-person and four phone visits |
|
| Week 10 |
| Change in commitment to quit | Change in commitment scores between baseline and end of treatment | Week 10 |
| CO-confirmed 7-day point prevalence abstinence from cigarette smoking | Preliminary efficacy for smoking cessation | Weeks 10 |
| CO-confirmed 7-day point prevalence abstinence from cigarette smoking | Preliminary efficacy for smoking cessation | Week 14 |
| Change in bipolar disorder symptoms | Change in mania and depression scale scores | Week 10 |
| Denver |
| Colorado |
| 80228 |
| United States |
| Bedford VA Research Corp | Bedford | Massachusetts | 01730 | United States |
| VA Central Western Massachusetts Healthcare System | Leeds | Massachusetts | 01503 | United States |
| D015438 |
| Health Behavior |