Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder



Status:Active, not recruiting
Conditions:Smoking Cessation, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:April 3, 2017
End Date:July 2019

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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.

Inclusion Criteria:

1. Age 18 or older

2. Daily smoker for the past year, averaging at least 5 cigarettes per day for the past
30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm

3. Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time
of phone pre-screening)

4. Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria

5. Willing to be randomly assigned to either treatment group

6. Has at least weekly access to a high-speed Internet connection

7. Willing and able to read in English

8. Is under care of a clinician for the treatment of bipolar disorder

Exclusion Criteria:

1. Participating in other smoking cessation interventions

2. Currently using any pharmacotherapies for smoking cessation

3. Previous use of the Smokefree.gov website

4. Current mania (Altman Self Rating Mania Scale score > 5) or severe depression (Patient
Health Questionnaire-9 score > 14)

5. Psychiatric hospitalization within one month prior to screening

6. Current suicidal or homicidal ideation

7. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in
past month

8. Unstable medical condition

9. Any medical or psychiatric condition that, in the opinion of the investigator, is
severe enough to interfere with protocol adherence or ability to benefit from the
intervention

10. Any medical conditions that would preclude use of the nicotine patch (e.g., recent
myocardial infarction, significant skin disorder, previous severe adverse reaction to
nicotine patch, pregnant or breast feeding, assessed with our standard protocol for
determining NRT eligibility)
We found this trial at
5
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Bedford, Massachusetts 01730
Principal Investigator: Megan Kelly, Ph.D.
Phone: 781-687-3228
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Denver, Colorado 80228
Principal Investigator: Jeanette Waxmonsky, Ph.D.
Phone: 720-788-4615
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Leeds, Massachusetts 01503
Principal Investigator: Kristin Mattock, Ph.D.
Phone: 413-584-4040
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Palo Alto, California 94304
Principal Investigator: Michael Ostacher, M.D., MPH, MMSc
Phone: 650.493.5000
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Palo Alto, CA
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