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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA041163-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | 8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling | Behavioral | individual, weekly, smoking cessation counseling + over-the-counter nicotine patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Task Persistence - Mirror Tracing | Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence - Sustained Divided Attention Task | Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence - Breath-holding | Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P) | Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence - 2-item Task Persistence Measure | Score on 2-item Task Persistence Measure (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence - Distress Tolerance Scale (DTS) | Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence) | Through end-of-treatment - approximately 8 weeks after baseline |
| Task Persistence - Thoughts About Smoking Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc L Steinberg, Ph.D. | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
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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 | Jun 26, 2018 | Jan 15, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2017 | Jan 15, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence) |
| Through end-of-treatment - approximately 8 weeks after baseline |
| Self-reported ratings of ease of understanding and helpfulness of counseling | percentage of participants who rate the intervention as "easy to understand" and "helpful" | Through end-of-treatment - approximately 8 weeks after baseline |
| D005159 | Health Care Facilities Workforce and Services |