Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Not Applicable

Completed

Conditions: Tobacco Use
Tobacco Use Cessation
Tobacco Smoking
Tobacco Use Disorder
Schizophrenia
Schizoaffective Disorder

Interventions: Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S)
Drug: Nicotine patch

Registration Number: NCT03873337

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.

Detailed Description: The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.

We will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter). All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified \<8ppm).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

Inclusion Criteria

Must be between 18 - 70 years old
Must indicate willingness to make a quit attempt in the next 30 days
Must report being a daily cigarette smoker (including those labeled "little cigars") for past month
Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV)
Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks
Must have a smartphone, tablet, or computer with ability to download apps
Must currently receive mental health treatment
Must sign release of information for current mental health treatment providers

Exclusion Criteria

Must not currently (in past 10 days) be taking varenicline (Chantix),
Must not currently (in past 10 days) be taking bupropion (Zyban/Wellbutrin) to quit smoking.
Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days
Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
Must not have pending legal matters with potential to result in jail time
Must not be planning on moving outside local area in next 3-months
Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NRT + Persistence Targeted Smoking Cessation in SMI	Nicotine patch	Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.
NRT + Persistence Targeted Smoking Cessation in SMI	Persistence Targeted Smoking Cessation in SMI (PTSC-S)	Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.

Primary Outcome Measures

Name	Time	Method
Feasibility 3: Participant Attendance	8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)	Participants in the PTSC-S intervention will attend at least 60% of their sessions
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date	3-months post quit date (approximately 4 months after baseline assessment)	We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date	3-months post quit date (approximately 4 months after baseline assessment)	We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Acceptability 1: Participant Rating of Usefulness of Intervention	3-months post quit date (approximately 4-months after baseline assessment)	After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.
Acceptability 2: Participant Rating of Counseling Session Length	3-months post quit date (approximately 4 months after baseline assessment)	After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.
Feasibility 2: Missing/Unusable Data	3-months post quit date (approximately 4 months after baseline assessment)	We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Prolonged Abstinence at at 3-month Followup	3-months post target quit date (approximately 4 months after baseline assessment)	Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO\<8ppm
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up	3-months post target quit date (approximately 4 months after baseline assessment)	No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO\<8ppm
Number of Participants With Prolonged Abstinence at End-of-counseling	End-of-counseling (8 weeks)	Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO\<8ppm
Task Persistence Scores	2 months after baseline assessment and 4 months after baseline assessment	14-item Thoughts About Smoking Questionnaire (TASQ). Lower scores represent greater task persistence. The total score can range from a minimum of 14 to a maximum of 98.
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling	End-of-counseling (8 weeks)	No smoking on the 7 days before the final counseling session, biochemically verified with CO\<8ppm
Cigarettes Per Day	2 months after baseline assessment and 4 months after baseline assessment	Hypothesis 3: As compared to baseline, participants will report smoking fewer cigarettes per day at 2- and 4-months post-baseline. Analysis 3: One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day on the TASQ at each timepoint.