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

Bipolar Disorder Clinical Trial

— WebQuit Plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750904
• Other study ID #: IR File# 8363
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: May 14, 2019

Study information

• Verified date: October 2019
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Smoking

Intervention

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.
• Control plus Nicotine Replacement Therapy
Includes four in-person and four phone visits

Locations

Country	Name	City	State
United States	Bedford VA Research Corp	Bedford	Massachusetts
United States	Jefferson Center for Mental Health	Denver	Colorado
United States	VA Central Western Massachusetts Healthcare System	Leeds	Massachusetts
United States	Palo Alto Veterans Institute for Research	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Bedford Research Corporation, Inc., Jefferson Center, Community Mental Health Clinic, Palo Alto Veterans Institute for Research, VA Central Western Massachusetts Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number approached, screened, eligible, and consented; reasons for ineligibility or refusal	Week -1 (Visit 0)
Primary	Recruitment	Number approached, screened, eligible, and consented; reasons for ineligibility or refusal	Week 0 (Visit 1)
Primary	Completion of the experimental intervention	Completion of the core treatment program	Week 10
Primary	Retention in study	Percentage of participants in each arm completing outcome assessments at end of treatment visit	Week 10
Primary	Retention in study	Percentage of participants in each arm completing outcome assessments at 1-month follow-up visit	Week 14
Primary	Treatment satisfaction	12 item survey used in our prior work assessing satisfaction with the assigned treatment	Week 10
Primary	Treatment utilization	Server-recorded log-ins to the assigned treatment	Week 10
Primary	Change in acceptance of smoking triggers	Change in acceptance scores between baseline and end of treatment	Week 10
Primary	Change in commitment to quit	Change in commitment scores between baseline and end of treatment	Week 10
Primary	CO-confirmed 7-day point prevalence abstinence from cigarette smoking	Preliminary efficacy for smoking cessation	Weeks 10
Primary	CO-confirmed 7-day point prevalence abstinence from cigarette smoking	Preliminary efficacy for smoking cessation	Week 14
Primary	Change in bipolar disorder symptoms	Change in mania and depression scale scores	Week 10