Resilience Skills Self-Management for Chronic Pain.

University of Michigan

Status: Completed

Conditions: Fibromyalgia; Chronic Spine Pain

Treatments: Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management; Behavioral: Promoting Resilience through Innovative Self-Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03304613

5R01NR017096-05 (U.S. NIH Grant/Contract)

HUM00124722

Details and patient eligibility

About

The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4

Enrollment: 300 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary back or spine pain diagnosis from the Back & Pain Center at University of Michigan.
• High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.

Exclusion criteria

• Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
• Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
• Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
• Planned major surgery in the next 12 months;
• Pregnancy or taking steroid medications
• Recent pain interventions ≤6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
• Cognitive impairment or dementia (inability to give consent or meaningfully participate);
• Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
• Unable to read or fluently converse in English;
• Planning to move from the area in next 14 months;
• In the judgment of the PIs the individual would not be able to meaningfully participant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Standard Web-based Cognitive Behavioral Therapy (e-CBT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management

Resilience-Enhanced web-based CBT Program

Experimental group

Description:

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.

Treatment:

Behavioral: Promoting Resilience through Innovative Self-Management

Usual Care

No Intervention group

Description:

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.