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

NCT ID: NCT02750904

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2019-05-14

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.

Conditions

Smoking; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental therapy

Group Type: EXPERIMENTAL

Experimental plus Nicotine Replacement Therapy

Intervention Type: 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 Therapy

Group Type: ACTIVE_COMPARATOR

Control plus Nicotine Replacement Therapy

Intervention Type: BEHAVIORAL

Includes four in-person and four phone visits

Interventions

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.

Intervention Type: BEHAVIORAL

Control plus Nicotine Replacement Therapy

Includes four in-person and four phone visits

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: collaborator

Bedford Research Corporation, Inc.

OTHER

Sponsor Role: collaborator

Jefferson Center, Community Mental Health Clinic

UNKNOWN

Sponsor Role: collaborator

VA Central Western Massachusetts Healthcare System

UNKNOWN

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaimee Heffner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Institute

Locations

Palo Alto Veterans Institute for Research

Palo Alto, California, United States

Jefferson Center for Mental Health

Denver, Colorado, United States

Bedford VA Research Corp

Bedford, Massachusetts, United States

VA Central Western Massachusetts Healthcare System

Leeds, Massachusetts, United States

Countries

United States

Other Identifiers

IR File# 8363

Identifier Type: -

Identifier Source: org_study_id