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Cognitive Behavioral Therapy for Chronic Pain
N/A
Recruiting
Led By Gregory P. Beehler, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans age >=18 and <=79 years
A diagnosis of musculoskeletal pain of >three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
Study Summary
This trial will test if a six-session cognitive behavioral therapy intervention is effective for treating chronic pain in Veterans.
Who is the study for?
Veterans aged 18-79 with chronic musculoskeletal pain and functional impairment, conversant in English, stable on any pain or psychiatric meds for two months, and have used VA primary care in the past year. Excluded are those with substance use problems, unstable psychiatric status, pending disability claims, recent psychotherapy for pain, planned surgeries for pain or imminent suicide risk.Check my eligibility
What is being tested?
The trial is testing Brief Cognitive Behavioral Therapy (CBT) for Chronic Pain against usual primary care treatments. It aims to see if six sessions of Brief CBT can improve physical activity interference due to pain, psychological distress and other outcomes compared to standard care.See study design
What are the potential side effects?
Since this intervention involves therapy rather than medication there may not be direct 'side effects' like drugs have; however participants might experience emotional discomfort discussing painful experiences during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran aged between 18 and 79.
Select...
I have had muscle or joint pain for more than three months.
Select...
My pain level is at least 4 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at 12 week follow up
Brief Pain Inventory -- Pain Intensity subscale (BPI-P) to assess change at 12 week follow-up
Patient Health Questionnaire -- 9 (PHQ-9) to assess change at 12 week follow-up
+2 moreOther outcome measures
Pain Catastrophizing Scale (PCS) to assess role in mediation at 12 week follow up
Pain
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment as usual onlyExperimental Treatment1 Intervention
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Group II: Brief CBT for Chronic Pain and treatment as usualExperimental Treatment2 Interventions
Participants will receive Brief CBT-CP in addition to usual primary care treatment. Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,006 Total Patients Enrolled
14 Trials studying Musculoskeletal Pain
6,211 Patients Enrolled for Musculoskeletal Pain
Gregory P. Beehler, PhDPrincipal InvestigatorVA Western New York Healthcare System, Buffalo, NY
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Musculoskeletal Pain
30 Patients Enrolled for Musculoskeletal Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been deemed to be at high risk of attempting to harm yourself.I have had or will have surgery to manage pain.I am receiving mental health services not related to chronic pain.I have been in therapy for chronic pain within the last year.I am a veteran aged between 18 and 79.My pain medication dose has been the same for the last two months.I am not comfortable with my treatment sessions being audio recorded.You currently have a serious problem with using alcohol, opioids, benzodiazepines, or other drugs.I have been diagnosed with a significant memory or thinking problem.My psychiatric medication dose has been stable for the last two months.You have a score of 4 or more on the pain and interference items during the screening.I have had muscle or joint pain for more than three months.My pain level is at least 4 out of 10.
Research Study Groups:
This trial has the following groups:- Group 1: Brief CBT for Chronic Pain and treatment as usual
- Group 2: Treatment as usual only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently involved in this research endeavor?
"Correct. According to clinicaltrials.gov, the study is actively enrolling participants from its initial posting on October 1st 2021 and last update on September 21st 2022. 178 people are needed for this single-site trial."
Answered by AI
Is this research endeavor currently open to participants?
"Affirmative, the clinicaltrials.gov database denotes that this trial is currently enrolling individuals. Inception of the study occurred on October 1st 2021 and its most recent revision happened on September 21st 2022. A total of 178 participants need to be recruited from a single site for this research project."
Answered by AI
Does the study protocol permit adults over 18 to participate?
"Per the trial's inclusion criteria, participants must be aged between 18 and 79 inclusively."
Answered by AI
Am I qualified to participate in this trial?
"Patients with musculoskeletal pain and aged between 18-79 are eligible to be recruited for this medical trial. Overall, the team aims to onboard 178 participants."
Answered by AI
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