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

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

Study Overview

• Status: Completed
• Conditions: Smoking; Bipolar Disorder
• Intervention / Treatment: Behavioral: Experimental plus Nicotine Replacement Therapy; Behavioral: Control plus Nicotine Replacement Therapy

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Palo Alto Veterans Institute for Research
  • Colorado
    • Denver, Colorado, United States, 80228
      • Jefferson Center for Mental Health
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Bedford VA Research Corp
    • Leeds, Massachusetts, United States, 01503
      • VA Central Western Massachusetts Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental therapy	Behavioral: Experimental plus Nicotine Replacement Therapy; 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.
Active Comparator: Control Therapy	Behavioral: Control plus Nicotine Replacement Therapy; Includes four in-person and four phone visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: Palo Alto Veterans Institute for Research; Bedford Research Corporation, Inc.; Jefferson Center, Community Mental Health Clinic; VA Central Western Massachusetts Healthcare System
• Investigators: Principal Investigator: Jaimee Heffner, Ph.D., Fred Hutchinson Cancer Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Smoking Cessation; Cognitive Behavioral Therapy; Acceptance & Commitment Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IR File# 8363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No