Schizoaffective Disorder, Schizophrenia, Tobacco Smoking, Tobacco Use, Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
tobacco, cigarette, schizophrenia, schizoaffective disorders, smoking cessation
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).
Interventions
BEHAVIORALPersistence Targeted Smoking Cessation in SMI (PTSC-S)
All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth
DRUGNicotine patch
All participants will receive 10 weeks of nicotine patch
Sponsors
National Institute on Drug Abuse (NIDA)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | NRT + Persistence Targeted Smoking Cessation in SMI |
|---|---|
| Age, Continuous | 42.65 years STANDARD_DEVIATION 11.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 34 participants |
| relight No | 10 Participants |
| relight Yes | 24 Participants |
| Sex/Gender, Customized Female | 17 Participants |
| Sex/Gender, Customized Gender Nonconforming | 1 Participants |
| Sex/Gender, Customized Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 34 |
| other Total, other adverse events | 19 / 34 |
| serious Total, serious adverse events | 3 / 34 |
Outcome results
Primary
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)
Population: Participants who attended at least 1 counseling session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 1: Participant Rating of Usefulness of Intervention | Easy to understand | 6.62 units on a scale | Standard Deviation 0.95 |
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 1: Participant Rating of Usefulness of Intervention | Helpful | 6.58 units on a scale | Standard Deviation 0.97 |
Primary
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)
Population: Participants who attended at least one counseling session.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 2: Participant Rating of Counseling Session Length | 2.29 units on a scale | Standard Deviation 1.93 |
Primary
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)
Population: Participants who responded to the item regarding acceptability of setting the target quit date for the 4th session.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date | 4th session was too soon | 14 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date | Fourth session was too late | 2 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date | Fourth session was at just about the right time. | 12 Participants |
Primary
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)
Population: Participants enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date | 28 Participants |
Primary
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 2: Missing/Unusable Data | 184 Missing CO points (out of 340) |
Primary
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)
Population: All participants enrolled in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 3: Participant Attendance | Attended 0 of 8 counseling sessions | 1 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 3: Participant Attendance | Attended 1 of 8 counseling session | 2 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 3: Participant Attendance | Attended 2 of 8 counseling sessions | 5 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 3: Participant Attendance | Attended 3 of 8 counseling sessions | 4 Participants |
| NRT + Persistence Targeted Smoking Cessation in SMI | Feasibility 3: Participant Attendance | Attended all 8 counseling sessions | 22 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Cigarettes Per Day | 2 months post-baseline | 7.01 cigarettes per day | Standard Deviation 8.34 |
| NRT + Persistence Targeted Smoking Cessation in SMI | Cigarettes Per Day | 4 months post-baseline | 8.48 cigarettes per day | Standard Deviation 9.31 |
Comparison: 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.p-value: <0.001t-test, 1 sided
Comparison: 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.p-value: <0.001t-test, 1 sided
Secondary
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)
Population: Participants enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Number of Participants With Prolonged Abstinence at at 3-month Followup | 2 Participants |
Secondary
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)
Population: Participants enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Number of Participants With Prolonged Abstinence at End-of-counseling | 2 Participants |
Secondary
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)
Population: Participants enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up | 3 Participants |
Secondary
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)
Population: Participants enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling | 3 Participants |
Secondary
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
Population: Participants for whom we have baseline and 2-months post-baseline data (n=26) and 4-months post-baseline data (n=28).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Task Persistence Scores | 2 months post-baseline | 44.19 units on a scale | Standard Deviation 21.72 |
| NRT + Persistence Targeted Smoking Cessation in SMI | Task Persistence Scores | 4 months post-baseline | 47.39 units on a scale | Standard Deviation 26.34 |
Comparison: 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.p-value: <0.001t-test, 1 sided
Comparison: 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.p-value: 0.002t-test, 1 sided