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Completed

NCT Number: NCT02750904

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

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

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Key information

Conditions

Smoking Behavior Bipolar Disorder Bipolar and Related Disorders Health Behavior Mental Disorders Mood Disorders Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Veterans Institute for Research, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • 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
  • Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)
  • Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria
  • Willing to be randomly assigned to either treatment group
  • Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer
  • Willing and able to read in English
  • Is under care of a clinician for the treatment of bipolar disorder
  • Willing to authorize communication with the clinician regarding study participation and clinical deterioration
  • Willing to use the nicotine patch to help quit smoking

Exclusion criteria

  • Participating in other smoking cessation interventions
  • Currently using any pharmacotherapies for smoking cessation
  • Previous use of the Smokefree.gov website
  • Meets DSM-V criteria for current mania
  • Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score > 14)
  • Current psychotic symptoms
  • Psychiatric hospitalization within one month prior to enrollment
  • Current suicidal or homicidal ideation
  • Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
  • Unstable medical condition
  • 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
  • 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)
  • Employee or family member of the investigator or study center, or member of the same household as another research participant

Treatment and study plan

Experimental plus Nicotine Replacement Therapy

Behavioral

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.

Control plus Nicotine Replacement Therapy

Behavioral

Includes four in-person and four phone visits

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Bedford Research Corporation, Inc.
  • Jefferson Center, Community Mental Health Clinic
  • Palo Alto Veterans Institute for Research
  • VA Central Western Massachusetts Healthcare System

Registry information

Acronym: WebQuit Plus

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2016
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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