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| ID | Type | Description | Link |
|---|---|---|---|
| R33DA041163 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Experimental | Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persistence Targeted Smoking Cessation in SMI (PTSC-S) | Behavioral | All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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". | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End-of-counseling (8 weeks) |
| Number of Participants With Prolonged Abstinence at End-of-counseling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc L Steinberg, Ph.D. | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Addiction Psychiatry | New Brunswick | New Jersey | 08901 | United States |
Requests for de-identified data from qualified researchers will be considered once the study has been completed.
Data will become available once the study has been completed and primary and secondary outcomes have been published.
Requests will be evaluated by the principal investigator. Access will be granted to the scientific researchers providing a valid scientific rationale for the request.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2022 |
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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.
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| Nicotine patch | Drug | All participants will receive 10 weeks of nicotine patch |
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| 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 | 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks) |
Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm |
| 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 | 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 | 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. | 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. | 2 months after baseline assessment and 4 months after baseline assessment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, Continuous (in years) as self reported by participants. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Gender Identity as self-reported by participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| relight | Do you sometimes "butt out" or extinguish and re-light your cigarettes? (Yes/No) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who attended at least 1 counseling session. | Posted | Mean | Standard Deviation | units on a scale | 3-months post quit date (approximately 4-months after baseline assessment) |
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| 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. | Participants who attended at least one counseling session. | Posted | Mean | Standard Deviation | units on a scale | 3-months post quit date (approximately 4 months after baseline assessment) |
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| 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". | Participants who responded to the item regarding acceptability of setting the target quit date for the 4th session. | Posted | Count of Participants | Participants | 3-months post quit date (approximately 4 months after baseline assessment) |
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| 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. | Participants enrolled. | Posted | Count of Participants | Participants | 3-months post quit date (approximately 4 months after baseline assessment) |
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| 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. | 340 potential CO data points (Participants enrolled in the study (N=34) with a potential 10 CO assessments each = 340 potential CO data points) | Posted | Number | Missing CO points (out of 340) | 3-months post quit date (approximately 4 months after baseline assessment) | CO assessment data points | CO assessment data points |
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| Primary | Feasibility 3: Participant Attendance | Participants in the PTSC-S intervention will attend at least 60% of their sessions | All participants enrolled in the study. | Posted | Count of Participants | Participants | 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks) |
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| 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 | Participants enrolled in the study. | Posted | Count of Participants | Participants | End-of-counseling (8 weeks) |
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| 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 | Participants enrolled in the study. | Posted | Count of Participants | Participants | End-of-counseling (8 weeks) |
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| 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 | Participants enrolled in the study. | Posted | Count of Participants | Participants | 3-months post target quit date (approximately 4 months after baseline assessment) |
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| 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 | Participants enrolled in the study. | Posted | Count of Participants | Participants | 3-months post target quit date (approximately 4 months after baseline assessment) |
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| 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. | Participants for whom we have baseline and 2-months post-baseline data (n=26) and 4-months post-baseline data (n=28). | Posted | Mean | Standard Deviation | units on a scale | 2 months after baseline assessment and 4 months after baseline assessment |
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| 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. | 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. | Posted | Mean | Standard Deviation | cigarettes per day | 2 months after baseline assessment and 4 months after baseline assessment |
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Four months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 34 | 3 | 34 | 19 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fractured nose | Injury, poisoning and procedural complications | Non-systematic Assessment | Fall resulting in a fractured nose |
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| Psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation at the patch site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Nausea / Upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Cold symptoms | Infections and infestations | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Vivid dreams | Nervous system disorders | Non-systematic Assessment |
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| Increased psychiatric symptoms | Psychiatric disorders | Non-systematic Assessment | Increased psychotic symptoms and/or increased agitation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc L. Steinberg, Ph.D. | Rutgers Robert Wood Johnson Medical School | 732-235-4341 | marc.steinberg@rutgers.edu |
| Jun 17, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2021 | Apr 27, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012907 | Smoking |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Gender Nonconforming |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CO assessment data points |
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