Resilience Skills Self-Management for Chronic Pain.
CompletedNot applicableNCT03304613
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Resilience Skills Self-Management for Chronic Pain.
- Conditions
- Chronic Spine Pain
- Fibromyalgia
- Interventions
- Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management
- Behavioral: Promoting Resilience through Innovative Self-Management
- Sponsor
- University of Michigan
- Collaborators
- National Institute of Nursing Research (NINR)
- Start date
- 2017-11-16
- Primary completion
- 2022-02-28
- Sex
- All
- Age range
- from 35 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03304613