Trial Outcomes & Findings for Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) (NCT NCT03873337)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

3-months post quit date (approximately 4-months after baseline assessment)

Results posted on

2022-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	NRT + Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Overall Study STARTED	34
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Age, Continuous	42.65 years STANDARD_DEVIATION 11.96 • n=5 Participants
Sex/Gender, Customized Male	16 Participants n=5 Participants
Sex/Gender, Customized Female	17 Participants n=5 Participants
Sex/Gender, Customized Gender Nonconforming	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants
relight Yes	24 Participants n=5 Participants
relight No	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3-months post quit date (approximately 4-months after baseline assessment)

Population: Participants who attended at least 1 counseling session.

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.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=33 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Acceptability 1: Participant Rating of Usefulness of Intervention "Easy to understand"	6.62 units on a scale Standard Deviation 0.95
Acceptability 1: Participant Rating of Usefulness of Intervention "Helpful"	6.58 units on a scale Standard Deviation 0.97

PRIMARY outcome

Timeframe: 3-months post quit date (approximately 4 months after baseline assessment)

Population: Participants who attended at least one counseling session.

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.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=33 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Acceptability 2: Participant Rating of Counseling Session Length	2.29 units on a scale Standard Deviation 1.93

PRIMARY outcome

Timeframe: 3-months post quit date (approximately 4 months after baseline assessment)

Population: Participants who responded to the item regarding acceptability of setting the target quit date for the 4th session.

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".

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=28 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date 4th session was too soon	14 Participants
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date Fourth session was too late	2 Participants
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date Fourth session was at just about the right time.	12 Participants

PRIMARY outcome

Timeframe: 3-months post quit date (approximately 4 months after baseline assessment)

Population: Participants enrolled.

We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date	28 Participants

PRIMARY outcome

Timeframe: 3-months post quit date (approximately 4 months after baseline assessment)

Population: 340 potential CO data points (Participants enrolled in the study (N=34) with a potential 10 CO assessments each = 340 potential CO data points)

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.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=340 CO assessment data points Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Feasibility 2: Missing/Unusable Data	184 Missing CO points (out of 340)

PRIMARY outcome

Timeframe: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)

Population: All participants enrolled in the study.

Participants in the PTSC-S intervention will attend at least 60% of their sessions

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Feasibility 3: Participant Attendance Attended 0 of 8 counseling sessions	1 Participants
Feasibility 3: Participant Attendance Attended 1 of 8 counseling session	2 Participants
Feasibility 3: Participant Attendance Attended 2 of 8 counseling sessions	5 Participants
Feasibility 3: Participant Attendance Attended 3 of 8 counseling sessions	4 Participants
Feasibility 3: Participant Attendance Attended all 8 counseling sessions	22 Participants

SECONDARY outcome

Timeframe: End-of-counseling (8 weeks)

Population: Participants enrolled in the study.

No smoking on the 7 days before the final counseling session, biochemically verified with CO\<8ppm

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling	3 Participants

SECONDARY outcome

Timeframe: End-of-counseling (8 weeks)

Population: Participants enrolled in the study.

Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO\<8ppm

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Number of Participants With Prolonged Abstinence at End-of-counseling	2 Participants

SECONDARY outcome

Timeframe: 3-months post target quit date (approximately 4 months after baseline assessment)

Population: Participants enrolled in the study.

No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO\<8ppm

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up	3 Participants

SECONDARY outcome

Timeframe: 3-months post target quit date (approximately 4 months after baseline assessment)

Population: Participants enrolled in the study.

Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO\<8ppm

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Number of Participants With Prolonged Abstinence at at 3-month Followup	2 Participants

SECONDARY outcome

Timeframe: 2 months after baseline assessment and 4 months after baseline assessment

Population: Participants for whom we have baseline and 2-months post-baseline data (n=26) and 4-months post-baseline data (n=28).

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.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=28 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Task Persistence Scores 2 months post-baseline	44.19 units on a scale Standard Deviation 21.72
Task Persistence Scores 4 months post-baseline	47.39 units on a scale Standard Deviation 26.34

SECONDARY outcome

Timeframe: 2 months after baseline assessment and 4 months after baseline assessment

Population: Number of participants for whom we had data for mean cigarettes per day in the preceding week at baseline and 2 months post-baseline and at baseline and 4-months post-baseline.

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.

Outcome measures

Outcome measures
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=28 Participants Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Cigarettes Per Day 2 months post-baseline	7.01 cigarettes per day Standard Deviation 8.34
Cigarettes Per Day 4 months post-baseline	8.48 cigarettes per day Standard Deviation 9.31

Adverse Events

NRT + Persistence Targeted Smoking Cessation in SMI

Serious events: 3 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 participants at risk Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Injury, poisoning and procedural complications Fractured nose	2.9% 1/34 • Number of events 1 • Four months
Psychiatric disorders Psychiatric hospitalization	5.9% 2/34 • Number of events 2 • Four months

Other adverse events

Other adverse events
Measure	NRT + Persistence Targeted Smoking Cessation in SMI n=34 participants at risk Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. Persistence Targeted Smoking Cessation in SMI (PTSC-S): All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth Nicotine patch: All participants will receive 10 weeks of nicotine patch
Skin and subcutaneous tissue disorders skin irritation at the patch site	11.8% 4/34 • Number of events 4 • Four months
Gastrointestinal disorders Nausea / Upset stomach	8.8% 3/34 • Number of events 3 • Four months
Psychiatric disorders Depression	29.4% 10/34 • Number of events 11 • Four months
Psychiatric disorders Anxiety	17.6% 6/34 • Number of events 6 • Four months
Infections and infestations Cold symptoms	8.8% 3/34 • Number of events 3 • Four months
Nervous system disorders Headache	11.8% 4/34 • Number of events 4 • Four months
Nervous system disorders Vivid dreams	5.9% 2/34 • Number of events 2 • Four months
Psychiatric disorders Increased psychiatric symptoms	17.6% 6/34 • Number of events 6 • Four months

Additional Information

Marc L. Steinberg, Ph.D.

Rutgers Robert Wood Johnson Medical School

Phone: 732-235-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place