Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder (WebQuit Plus)

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Bipolar Disorder; Smoking

Treatments: Behavioral: Control plus Nicotine Replacement Therapy; Behavioral: Experimental plus Nicotine Replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02750904

IR File# 8363

Details and patient eligibility

About

This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 via a tablet, laptop or desktop computer
7. Willing and able to read in English
8. Is under care of a clinician for the treatment of bipolar disorder
9. Willing to authorize communication with the clinician regarding study participation and clinical deterioration
10. Willing to use the nicotine patch to help quit smoking

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. Meets DSM-V criteria for current mania
5. Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score > 14)
6. Current psychotic symptoms
7. Psychiatric hospitalization within one month prior to enrollment
8. Current suicidal or homicidal ideation
9. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
10. Unstable medical condition
11. 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
12. 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)
13. Employee or family member of the investigator or study center, or member of the same household as another research participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Experimental therapy

Experimental group

Treatment:

Behavioral: Experimental plus Nicotine Replacement Therapy

Control Therapy

Active Comparator group

Treatment:

Behavioral: Control plus Nicotine Replacement Therapy