Resilience Skills Self-Management for Chronic Pain.



Status:Recruiting
Conditions:Fibromyalgia
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:35 - 65
Updated:12/29/2018
Start Date:November 16, 2017
End Date:October 2022
Contact:Afton Hassett, Psy.D.
Email:afton@med.umich.edu
Phone:734-998-6939

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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


Inclusion Criteria:

- Primary back or spine pain diagnosis from the Back & Pain Center at University of
Michigan.

- Meet 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.
We found this trial at
1
site
Ann Arbor, Michigan 48106
Phone: 734-763-5226
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Ann Arbor, MI
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