Pain Clinical Trial
— PASSOfficial title:
Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans
Verified date | July 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain
Status | Completed |
Enrollment | 371 |
Est. completion date | January 31, 2022 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Veterans enrolled at VA Connecticut or VA Central Western Massachusetts - Current Cigarette Smokers - Willing to make quit attempt in next 30 days - Pain intensity 4 or greater on scale 0-10, self-reported Exclusion Criteria: - Non-English speaking - No access to telephone/Lack of Telephone Access - Severely impaired hearing - Active diagnosis - Terminal Illness - Refusal to provide informed consent - Enrolled in concurrent smoking cessation programs/research |
Country | Name | City | State |
---|---|---|---|
United States | VA Central Western Massachusetts Healthcare System, Leeds, MA | Leeds | Massachusetts |
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counse — View Citation
Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140. — View Citation
Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2 — View Citation
Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pai — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? | 6-month | |
Primary | Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) | In the past 6 months, have he/she smoked any in each of 2 consecutive weeks? | 12-month post intervention | |
Primary | Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) | 30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days? | 6-month post intervention | |
Primary | Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) | 30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days? | 12 month post intervention | |
Secondary | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months | BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased. | Baseline to 6-month post intervention | |
Secondary | Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months | Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased. | Baseline to 6-month post intervention | |
Secondary | Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months | BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased. | Baseline to 12-month post-intervention | |
Secondary | Change in Pain Interference, Difference Between Baseline and Interference | Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased | Baseline to 12-month post intervention |
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