Clinical trial NCT02750904: Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Official title: Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Bipolar Disorder
Keywords: Smoking Cessation
Acceptance & Commitment Therapy
Cognitive Behavioral Therapy
Bipolar Disorder
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Palo Alto Veterans Institute for Research
name: Bedford Research Corporation, Inc.
name: Jefferson Center, Community Mental Health Clinic
name: VA Central Western Massachusetts Healthcare System
First posted: 2016-04-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: Week -1 (Visit 0)
measure: Recruitment
timeFrame: Week 0 (Visit 1)
measure: Completion of the experimental intervention
timeFrame: Week 10
measure: Retention in study
timeFrame: Week 10
measure: Retention in study
timeFrame: Week 14
measure: Treatment satisfaction
timeFrame: Week 10
measure: Treatment utilization
timeFrame: Week 10
measure: Change in acceptance of smoking triggers
timeFrame: Week 10
measure: Change in commitment to quit
timeFrame: Week 10
measure: CO-confirmed 7-day point prevalence abstinence from cigarette smoking
timeFrame: Weeks 10
measure: CO-confirmed 7-day point prevalence abstinence from cigarette smoking
timeFrame: Week 14
measure: Change in bipolar disorder symptoms
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veterans Institute for Research
state: California
city: Denver
country: United States
facility: Jefferson Center for Mental Health
state: Colorado
city: Bedford
country: United States
facility: Bedford VA Research Corp
state: Massachusetts
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System
state: Massachusetts
Study officials:
affiliation: Fred Hutchinson Cancer Research Institute
name: Jaimee Heffner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: