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Cognitive Behavioral Therapy
Tailored Non-Pharmacotherapy Services for Chronic Pain (RESOLVE Trial)
N/A
Waitlist Available
Led By Lynn L DeBar, PhD, MPH
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English speaking or do not need interpreter services
Do not have two or more separate encounters with a malignant cancer diagnosis other than non-melanoma skin cancer within past 60 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3, 6, and 12 months
Awards & highlights
RESOLVE Trial Summary
This trial is testing whether CBT-CP delivered via a web-based application or live, coach-led, virtual sessions is more effective for chronic pain.
Who is the study for?
This trial is for adults over 18 with chronic pain who are enrolled in one of the participating health care systems. They must speak English, have internet and phone access, and have had recent healthcare visits for non-cancer-related musculoskeletal pain. People can't join if they've had recent CBT for pain, substance abuse treatment, or planned surgeries related to their condition.Check my eligibility
What is being tested?
The RESOLVE study tests two telehealth treatments for chronic pain: an online cognitive behavioral therapy-based program (CBT-CP) and a similar program led by a virtual coach via calls or video. Participants will receive either method to see which is more effective.See study design
What are the potential side effects?
Since this trial involves non-pharmacological interventions like online programs and coaching sessions, there aren't typical medication side effects. However, participants may experience emotional discomfort or fatigue from engaging in therapy.
RESOLVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or don't need an interpreter.
Select...
I have not been diagnosed with cancer, other than non-melanoma skin cancer, more than once in the last 60 days.
Select...
I am 18 years old or older.
Select...
I have ongoing pain.
Select...
I experience severe, long-lasting pain.
Select...
I have not received hospice or palliative care in the last year.
RESOLVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3, 6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3, 6, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achieving minimal clinically important difference (MCID) in pain severity at 3 months (yes/no)
Secondary outcome measures
Achieving MCID in pain severity at 6 and 12 months (yes / no)
Cost and incremental cost-effectiveness
Pain intensity
+5 moreRESOLVE Trial Design
3Treatment groups
Active Control
Group I: Usual Care plus informationActive Control1 Intervention
Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction
Group II: Online CBT-CP based programActive Control1 Intervention
Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)
Group III: Virtual coach-led CBT-CP based programActive Control1 Intervention
Live, coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted)
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Who is running the clinical trial?
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,417,736 Total Patients Enrolled
22 Trials studying Chronic Pain
8,800 Patients Enrolled for Chronic Pain
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
914,898 Total Patients Enrolled
12 Trials studying Chronic Pain
1,526 Patients Enrolled for Chronic Pain
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,111,495 Total Patients Enrolled
8 Trials studying Chronic Pain
6,391 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting or currently in cognitive behavioral therapy for pain.I have had cognitive behavioral therapy for pain in the last 6 months.I speak English or don't need an interpreter.I haven't had surgery for joint or muscle pain in the last 60 days.I have not been diagnosed with cancer, other than non-melanoma skin cancer, more than once in the last 60 days.I am scheduled for surgery to address my pain within the next year.I am 18 years old or older.I have ongoing pain.I have seen a doctor for non-cancer related muscle or bone pain at least once in the last year.I experience severe, long-lasting pain.You are currently getting help for a substance use problem in a hospital or intensive outpatient program, or you will be starting this kind of treatment in the next month.I have not received hospice or palliative care in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care plus information
- Group 2: Online CBT-CP based program
- Group 3: Virtual coach-led CBT-CP based program
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.
Are there still openings available for participants in this investigation?
"Clinicaltrials.gov reveals that this medical trial, originally posted on January 14th 2021, is not currently seeking participants. Nonetheless, 404 other studies are still actively recruiting patients at the moment."
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