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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 : August 12, 2019
Sponsor:
Collaborators:
Palo Alto Veterans Institute for Research
Bedford Research Corporation, Inc.
Jefferson Center, Community Mental Health Clinic
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 : 58 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


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. Change in smoking status as measured in carbon monoxide levels [ Time Frame: Weeks 0 &10 Change from baseline to post treatment follow up ]
    Reading of carbon monoxide level and change of score pre and post intervention

  2. Change in smoking status measured by change in Fagerstrom Test Nicotine Dependence (FTND) scores [ Time Frame: Weeks 0 &10 Change from baseline to post treatment scores ]
    The FTND is a 6-item, self reported scale that assesses the degree of physical dependence on nicotine.


Secondary Outcome Measures :
  1. Mechanism of Change Assessments - acceptance of smoking triggers [ Time Frame: Weeks 0 & 10 ]
    Avoidance and Inflexibility Scale - a 27-item scale that measuring change

  2. Mechanism of Change Assessments - commitment to quitting [ Time Frame: Weeks 0 & 10 ]
    Commitment to Quitting Scale - we are measuring changes in score from pre to post treatment

  3. Bipolar Disorder Symptom Assessments [ Time Frame: Weeks 0, 10, 14 ]
    We will measure bipolar disorder symptom changes over time by Scores of: Altman Self-Rating Mania Scale and the Patient Health Questionnaire

  4. Treatment Satisfaction Measure [ Time Frame: Weeks 0, 2, 4, 6, 8, & 10 ]
    Treatment satisfaction questionnaire is an 8-item scale

  5. Website Utilization Assessment [ Time Frame: Weeks 0, 2, 4, 6, 8, & 10 ]
    Website utilization tracking; we will determine which activities were completed

  6. Treatment utilization- NRT utilization measures [ Time Frame: Weeks 0, 2, 4, 6, 8, & 10 ]
    NRT Utilization, a self reported use of NRT (Nicotice Replacement Therapy)



Information from the National Library of Medicine

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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
  7. Willing and able to read in English
  8. Is under care of a clinician for the treatment of bipolar disorder

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. Current mania (Altman Self Rating Mania Scale score > 5) or severe depression (Patient Health Questionnaire-9 score > 14)
  5. Psychiatric hospitalization within one month prior to screening
  6. Current suicidal or homicidal ideation
  7. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month
  8. Unstable medical condition
  9. 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
  10. 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)

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
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     History of Changes
Other Study ID Numbers: IR File# 8363
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators will publish results of the study in peer reviewed, scientific journals.

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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