Skip to main content
Clinical Trials/NCT02750904
NCT02750904CompletedNot Applicable

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

Fred Hutchinson Cancer Center8 sites in 1 country51 target enrollmentStarted: April 3, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
8
Primary Endpoint
Completion of the experimental intervention

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Experimental therapy

Experimental

Intervention: Experimental plus Nicotine Replacement Therapy (Behavioral)

Control Therapy

Active Comparator

Intervention: Control plus Nicotine Replacement Therapy (Behavioral)

Outcomes

Primary Outcomes

Completion of the experimental intervention

Time Frame: Week 10

Completion of the core treatment program

Change in acceptance of smoking triggers

Time Frame: Week 10

Change in acceptance scores between baseline and end of treatment

Change in commitment to quit

Time Frame: Week 10

Change in commitment scores between baseline and end of treatment

CO-confirmed 7-day point prevalence abstinence from cigarette smoking

Time Frame: Week 14

Preliminary efficacy for smoking cessation

Treatment satisfaction

Time Frame: Week 10

12 item survey used in our prior work assessing satisfaction with the assigned treatment

Treatment utilization

Time Frame: Week 10

Server-recorded log-ins to the assigned treatment

Change in bipolar disorder symptoms

Time Frame: Week 10

Change in mania and depression scale scores

Recruitment

Time Frame: Week 0 (Visit 1)

Number approached, screened, eligible, and consented; reasons for ineligibility or refusal

Retention in study

Time Frame: Week 14

Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

Loading locations...

Similar Trials

Web-Delivered Acceptance & Commitment... | Clinical Trial