Clinical trial NCT03304613: Resilience Skills Self-Management for Chronic Pain.
Official title: Resilience Skills Self-Management for Chronic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spine Pain
Fibromyalgia
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60).
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
timeFrame: At 8-week assessment point
Secondary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: At 8-week assessment point
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At 8-week assessment point
measure: PROMIS Fatigue-Short Form
timeFrame: At 8-week assessment point
measure: Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)
timeFrame: At 8-week assessment point
measure: Subjective well-being
timeFrame: At 8-week assessment point
measure: Pain Catastrophizing Scale (PCS)
timeFrame: At 8-week assessment point
measure: Patient Health Questionnaire 9-item (PHQ-9):
timeFrame: At 8-week assessment point
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: At 8-week assessment point
measure: Perceived Stress Scale (PSS)
timeFrame: At 8-week assessment point
measure: Six-Minute Walk Test (6MWT)
timeFrame: At 8-week assessment point
measure: Sit-to-Stand Test
timeFrame: At 8-week assessment point
measure: Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method
timeFrame: At 8-week assessment point
measure: Telomere length
timeFrame: At 1 year assessment point
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Back & Pain Center, University of Michigan
state: Michigan
Study officials:
References: