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

Not Applicable

Completed

• Conditions: Smoking; Bipolar Disorder
• Interventions: Behavioral: Experimental plus Nicotine Replacement Therapy; Behavioral: Control plus Nicotine Replacement Therapy

• Registration Number: NCT02750904
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-26
• Study Start: 2017-04-03
• Primary Completion: 2019-05-14
• Study Completion: 2019-05-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental therapy	Experimental plus Nicotine Replacement Therapy	-
Control Therapy	Control plus Nicotine Replacement Therapy	-

Primary Outcome Measures

Name	Time	Method
Completion of the experimental intervention	Week 10	Completion of the core treatment program
Change in acceptance of smoking triggers	Week 10	Change in acceptance scores between baseline and end of treatment
Change in commitment to quit	Week 10	Change in commitment scores between baseline and end of treatment
CO-confirmed 7-day point prevalence abstinence from cigarette smoking	Week 14	Preliminary efficacy for smoking cessation
Treatment satisfaction	Week 10	12 item survey used in our prior work assessing satisfaction with the assigned treatment
Treatment utilization	Week 10	Server-recorded log-ins to the assigned treatment
Change in bipolar disorder symptoms	Week 10	Change in mania and depression scale scores
Recruitment	Week 0 (Visit 1)	Number approached, screened, eligible, and consented; reasons for ineligibility or refusal
Retention in study	Week 14	Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit

Trial Locations

Locations (4)

Jefferson Center for Mental Health; 🇺🇸 Denver, Colorado, United States

VA Central Western Massachusetts Healthcare System; 🇺🇸 Leeds, Massachusetts, United States

Bedford VA Research Corp; 🇺🇸 Bedford, Massachusetts, United States

Palo Alto Veterans Institute for Research; 🇺🇸 Palo Alto, California, United States