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

NCT02750904 | Completed DMC

• 1 other identifier: IR File# 8363
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Smoking; Bipolar Disorder

Keywords

Smoking Cessation; Acceptance & Commitment Therapy; Cognitive Behavioral Therapy; Bipolar Disorder

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Experimental therapy

EXPERIMENTAL

Behavioral: Experimental plus Nicotine Replacement Therapy

Control Therapy

ACTIVE COMPARATOR

Behavioral: Control plus Nicotine Replacement Therapy

Interventions

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.

Experimental therapy

Control plus Nicotine Replacement Therapy BEHAVIORAL

Includes four in-person and four phone visits

Control Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Palo Alto Veterans Institute for Research

Palo Alto, California, 94304, United States

Location

Jefferson Center for Mental Health

Denver, Colorado, 80228, United States

Location

Bedford VA Research Corp

Bedford, Massachusetts, 01730, United States

Location

VA Central Western Massachusetts Healthcare System

Leeds, Massachusetts, 01503, United States

Location

MeSH Terms

Conditions

Smoking; Bipolar Disorder; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jaimee Heffner, Ph.D.

  Fred Hutchinson Cancer Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 26, 2016
• Study Start: April 3, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)