PTSC-S: Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT03873337
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use; Tobacco Smoking; Tobacco Use Cessation; Tobacco Use Disorder; Schizophrenia; Schizoaffective Disorder	Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S); Drug: Nicotine patch	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
• Actual Study Start Date: Apr 22, 2019
• Actual Primary Completion Date: Jan 10, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NRT + Persistence Targeted Smoking Cessation in SMI Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.	Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S); All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth; Drug: Nicotine patch; All participants will receive 10 weeks of nicotine patch

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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".

4. 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.

5. 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.

6. 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

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. Task Persistence Scores [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.

6. Cigarettes Per Day [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Addiction Psychiatry	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Marc L Steinberg, Ph.D., Rutgers Robert Wood Johnson Medical School

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2022
• Informed Consent Form - Jun 17, 2021

More Information

Publications

None provided.

• Responsible Party: Marc L. Steinberg, Ph.D., Professor of Psychiatry, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03873337
• Other Study ID Numbers: Pro2018001696; R33DA041163
• First Posted: Mar 13, 2019
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Marc L. Steinberg, Ph.D., Professor of Psychiatry, Rutgers, The State University of New Jersey: tobacco; cigarette; schizophrenia; schizoaffective disorders; smoking cessation
• Additional relevant MeSH terms: Disease; Tobacco Use Disorder; Schizophrenia; Psychotic Disorders; Nicotine

Study Results

Participant Flow

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
Arm/Group Description	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
Period Title: Overall Study
STARTED	34
COMPLETED	22
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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 Participants	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.65 (11.96)
Sex/Gender, Customized (Count of Participants)
Male	16 47.1%
Female	17 50%
Gender Nonconforming	1 2.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 11.8%
Not Hispanic or Latino	30 88.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 8.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 17.6%
White	22 64.7%
More than one race	2 5.9%
Unknown or Not Reported	1 2.9%
Region of Enrollment (participants) [Number]
United States	34 100%
relight (Count of Participants)
Yes	24 70.6%
No	10 29.4%

Outcome Measures

1. Primary Outcome

Title	Acceptability 1: Participant Rating of Usefulness of Intervention
Description	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)

Outcome Measure Data

Analysis Population Description

Participants who attended at least 1 counseling session.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	33
"Easy to understand"	6.62 (0.95)
"Helpful"	6.58 (0.97)

2. Primary Outcome

Title	Acceptability 2: Participant Rating of Counseling Session Length
Description	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)

Outcome Measure Data

Analysis Population Description

Participants who attended at least one counseling session.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	33
Mean (Standard Deviation) [units on a scale]	2.29 (1.93)

3. Primary Outcome

Title	Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
Description	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	28
4th session was too soon	14 41.2%
Fourth session was too late	2 5.9%
Fourth session was at just about the right time.	12 35.3%

4. Primary Outcome

Title	Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
Description	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)

Outcome Measure Data

Analysis Population Description

Participants enrolled.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Count of Participants [Participants]	28 82.4%

5. Primary Outcome

Title	Feasibility 2: Missing/Unusable Data
Description	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.
Time Frame	3-months post quit date (approximately 4 months after baseline assessment)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Measure CO assessment data points	340
Number [Missing CO points (out of 340)]	184

6. Primary Outcome

Title	Feasibility 3: Participant Attendance
Description	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)

Outcome Measure Data

Analysis Population Description

All participants enrolled in the study.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Attended 0 of 8 counseling sessions	1 2.9%
Attended 1 of 8 counseling session	2 5.9%
Attended 2 of 8 counseling sessions	5 14.7%
Attended 3 of 8 counseling sessions	4 11.8%
Attended all 8 counseling sessions	22 64.7%

7. Secondary Outcome

Title	Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
Description	No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm
Time Frame	End-of-counseling (8 weeks)

Outcome Measure Data

Analysis Population Description

Participants enrolled in the study.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Count of Participants [Participants]	3 8.8%

8. Secondary Outcome

Title	Number of Participants With Prolonged Abstinence at End-of-counseling
Description	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)

Outcome Measure Data

Analysis Population Description

Participants enrolled in the study.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Count of Participants [Participants]	2 5.9%

9. Secondary Outcome

Title	Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
Description	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)

Outcome Measure Data

Analysis Population Description

Participants enrolled in the study.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Count of Participants [Participants]	3 8.8%

10. Secondary Outcome

Title	Number of Participants With Prolonged Abstinence at at 3-month Followup
Description	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)

Outcome Measure Data

Analysis Population Description

Participants enrolled in the study.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	34
Count of Participants [Participants]	2 5.9%

11. Secondary Outcome

Title	Task Persistence Scores
Description	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	4 months after baseline assessment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	28
2 months post-baseline	44.19 (21.72)
4 months post-baseline	47.39 (26.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NRT + Persistence Targeted Smoking Cessation in SMI
	Comments	One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	not adjusted for multiple comparisons
	Method	t-test, 1 sided
	Comments	df = 25

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NRT + Persistence Targeted Smoking Cessation in SMI
	Comments	One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	not adjusted for multiple comparisons
	Method	t-test, 1 sided
	Comments	df = 27

12. Secondary Outcome

Title	Cigarettes Per Day
Description	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	4 months after baseline assessment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
Measure Participants	28
2 months post-baseline	7.01 (8.34)
4 months post-baseline	8.48 (9.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NRT + Persistence Targeted Smoking Cessation in SMI
	Comments	One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	not adjusted for multiple comparisons
	Method	t-test, 1 sided
	Comments	df = 27

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	NRT + Persistence Targeted Smoking Cessation in SMI
	Comments	One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	not adjusted for multiple comparisons
	Method	t-test, 1 sided
	Comments	df = 27

Adverse Events

Time Frame	Four months
Arm/Group Title	NRT + Persistence Targeted Smoking Cessation in SMI
Arm/Group Description	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
All Cause Mortality
	NRT + Persistence Targeted Smoking Cessation in SMI
	Affected / at Risk (%)	# Events
Total	2/34 (5.9%)
Serious Adverse Events
	NRT + Persistence Targeted Smoking Cessation in SMI
	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)
Injury, poisoning and procedural complications
Fractured nose	1/34 (2.9%)	1
Psychiatric disorders
Psychiatric hospitalization	2/34 (5.9%)	2
Other (Not Including Serious) Adverse Events
	NRT + Persistence Targeted Smoking Cessation in SMI
	Affected / at Risk (%)	# Events
Total	19/34 (55.9%)
Gastrointestinal disorders
Nausea / Upset stomach	3/34 (8.8%)	3
Infections and infestations
Cold symptoms	3/34 (8.8%)	3
Nervous system disorders
Headache	4/34 (11.8%)	4
Vivid dreams	2/34 (5.9%)	2
Psychiatric disorders
Depression	10/34 (29.4%)	11
Anxiety	6/34 (17.6%)	6
Increased psychiatric symptoms	6/34 (17.6%)	6
Skin and subcutaneous tissue disorders
skin irritation at the patch site	4/34 (11.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.