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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth
All participants will receive 10 weeks of nicotine patch
Division of Addiction Psychiatry
New Brunswick, New Jersey, United States
Acceptability 1: Participant Rating of Usefulness of Intervention
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.
Time frame: 3-months post quit date (approximately 4-months after baseline assessment)
Acceptability 2: Participant Rating of Counseling Session Length
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.
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
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".
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 2: Missing/Unusable Data
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.
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Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 3: Participant Attendance
Participants in the PTSC-S intervention will attend at least 60% of their sessions
Time frame: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
No smoking on the 7 days before the final counseling session, biochemically verified with CO\<8ppm
Time frame: End-of-counseling (8 weeks)
Number of Participants With Prolonged Abstinence at End-of-counseling
Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO\<8ppm
Time frame: End-of-counseling (8 weeks)
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO\<8ppm
Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)
Number of Participants With Prolonged Abstinence at at 3-month Followup
Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO\<8ppm
Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)
Task Persistence Scores
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.
Time frame: 2 months after baseline assessment and 4 months after baseline assessment
Cigarettes Per Day
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.
Time frame: 2 months after baseline assessment and 4 months after baseline assessment