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Promoting Resilience through Innovative Self-Management for Chronic Back Pain

N/A

Waitlist Available

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year assessment point

Awards & highlights

Study Summary

This trial is testing whether two different types of online self-management programs can help reduce pain and improve quality of life for people with chronic pain, compared to receiving usual care.

Eligible Conditions

Chronic Back Pain
Fibromyalgia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year assessment point

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year assessment point

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year assessment point for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fibromyalgia Impact Questionnaire-Revised (FIQ-R)

Secondary outcome measures

Brief Pain Inventory (BPI)

Generalized Anxiety Disorder 7-item (GAD-7)

Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Resilience-Enhanced web-based CBT ProgramExperimental Treatment1 Intervention

Patients randomized to PRISM will undergo "Promoting Resilience through Innovative Self-Management" (PRISM) and meet with the MA for an orientation session. The MA describes the program, explains the rationale for treatment, and directs them to the FibroGuide and PRISM websites. Materials and worksheets are provided in the first visit and available online. The e-CBT elements retained are the core elements of CBT for pain, while the resilience-based activities capitalize on the best practices for positive activities interventions including having multiple overlapping activities, making favored activities standard practice beyond the study and having a coaching component.

Group II: Standard Web-based Cognitive Behavioral Therapy (e-CBT)Active Control1 Intervention

Patients randomized to e-CBT will undergo "Standard Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management Program" and meet with a study medical assistant (MA) for an orientation session. The MA provides an overview of the program, explains the rationale for treatment, and directs them to the FibroGuide website. FibroGuide features the CBT modules that will be used by both groups. Patients will complete one module per week. Materials needed for the 8-week intervention including the instructions for each activity and forms for the written aspects of an activity (worksheets) will be provided in the first visit and available online. The FibroGuide website evolved from the evidence-based website Living Well with Fibromyalgia that has established efficacy for improving functional status and reducing pain.

Group III: Usual CareActive Control1 Intervention

Patients randomized to the usual care only group will have no contact with the study MAs. Usual care patients return for the same follow-up assessments (and electronic medical record review) at 8 weeks and at 6 and 12 months. Whereas major surgery including surgeries for pain, are exclusion criteria, spine and pain injections will be permitted.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Promoting Resilience through Innovative Self-Management

2017

N/A

~300

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,261 Total Patients Enrolled

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,377,758 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met to qualify for participation in this research experiment?

"This study is recruiting 300 individuals aged 35-65 who have fibromyalgia and report high scores on the 2011 survey criteria for Fibromyalgia, which assesses both widespread pain severity and symptom intensity."

Answered by AI

Is this study open to those of advanced age?

"In accordance with the prerequisites for this trial, applicants must be between 35 and 65 years old."

Answered by AI

Is this research endeavor recruiting participants at present?

"This research study, which was initially posted on November 16th 2017 and last updated February 25th 2022 has concluded its recruitment efforts. Nevertheless, there are still 483 other medical trials seeking participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Resilience Skills Self-Management for Chronic Pain.

Afton Hassett, Psy.D. 2017. "Resilience Skills Self-Management for Chronic Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03304613.