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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02750904
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : October 14, 2019
Sponsor:
Collaborators:
Palo Alto Veterans Institute for Research
Bedford Research Corporation, Inc.
Jefferson Center, Community Mental Health Clinic
VA Central Western Massachusetts Healthcare System
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research 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.

Condition or disease Intervention/treatment Phase
Smoking Bipolar Disorder Behavioral: Experimental plus Nicotine Replacement Therapy Behavioral: Control plus Nicotine Replacement Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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




Primary Outcome Measures :
  1. Recruitment [ Time Frame: Week -1 (Visit 0) ]
    Number approached, screened, eligible, and consented; reasons for ineligibility or refusal

  2. Recruitment [ Time Frame: Week 0 (Visit 1) ]
    Number approached, screened, eligible, and consented; reasons for ineligibility or refusal

  3. Completion of the experimental intervention [ Time Frame: Week 10 ]
    Completion of the core treatment program

  4. Retention in study [ Time Frame: Week 10 ]
    Percentage of participants in each arm completing outcome assessments at end of treatment visit

  5. Retention in study [ Time Frame: Week 14 ]
    Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit

  6. Treatment satisfaction [ Time Frame: Week 10 ]
    12 item survey used in our prior work assessing satisfaction with the assigned treatment

  7. Treatment utilization [ Time Frame: Week 10 ]
    Server-recorded log-ins to the assigned treatment

  8. Change in acceptance of smoking triggers [ Time Frame: Week 10 ]
    Change in acceptance scores between baseline and end of treatment

  9. Change in commitment to quit [ Time Frame: Week 10 ]
    Change in commitment scores between baseline and end of treatment

  10. CO-confirmed 7-day point prevalence abstinence from cigarette smoking [ Time Frame: Weeks 10 ]
    Preliminary efficacy for smoking cessation

  11. CO-confirmed 7-day point prevalence abstinence from cigarette smoking [ Time Frame: Week 14 ]
    Preliminary efficacy for smoking cessation

  12. Change in bipolar disorder symptoms [ Time Frame: Week 10 ]
    Change in mania and depression scale scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750904


Locations
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United States, California
Palo Alto Veterans Institute for Research
Palo Alto, California, United States, 94304
United States, Colorado
Jefferson Center for Mental Health
Denver, Colorado, United States, 80228
United States, Massachusetts
Bedford VA Research Corp
Bedford, Massachusetts, United States, 01730
VA Central Western Massachusetts Healthcare System
Leeds, Massachusetts, United States, 01503
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Palo Alto Veterans Institute for Research
Bedford Research Corporation, Inc.
Jefferson Center, Community Mental Health Clinic
VA Central Western Massachusetts Healthcare System
Investigators
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Principal Investigator: Jaimee Heffner, Ph.D. Fred Hutchinson Cancer Research Institute
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02750904    
Other Study ID Numbers: IR File# 8363
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fred Hutchinson Cancer Research Center:
Smoking Cessation
Acceptance & Commitment Therapy
Cognitive Behavioral Therapy
Bipolar Disorder
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action