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Resilience Skills Self-Management for Chronic Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03304613
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : December 27, 2018
Information provided by (Responsible Party):
Afton Hassett, Psy.D., University of Michigan

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

Condition or disease Intervention/treatment Phase
Chronic Spine Pain Fibromyalgia Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management Behavioral: Promoting Resilience through Innovative Self-Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resilience Skills Self-Management for Chronic Pain.
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard Web-based Cognitive Behavioral Therapy (e-CBT)
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.
Behavioral: Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management
Already noted.

Experimental: Resilience-Enhanced web-based CBT Program
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.
Behavioral: Promoting Resilience through Innovative Self-Management
Already noted.
Other Name: PRISM

No Intervention: Usual Care
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.

Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire-Revised (FIQ-R) [ Time Frame: At 8-week assessment point ]
    The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.

Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: At 8-week assessment point ]
    The BPI is a 15-item self-report measure that has been validated for use in a wide variety of pain states. The BPI assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: At 8-week assessment point ]
    The PSQI is a widely used, valid and reliable measure of global sleep quality and sleep-related symptoms.149 The 19-items yield 7 component-scores that reflect common sleep problems such as subjective sleep quality, sleep disturbance and use of sleep medication.

  3. PROMIS Fatigue-Short Form [ Time Frame: At 8-week assessment point ]
    The PROMIS Fatigue-Short Form consists of 8 items that assess the impact and experience of fatigue in the past week. It uses a 5-point Likert-like scale with response options that range from "Not at all" to "Very much." A raw score is calculated by summing scores across items then a conversion table is used to calculate T-scores with higher scores indicating greater fatigue.

  4. Multidimensional Inventory of Subjective Cognitive Impairment (MISCI) [ Time Frame: At 8-week assessment point ]
    The MISCI is a 10-item measure based upon items developed for PROMIS that assesses perceived difficulties within 5 domains: mental clarity, memory, language, executive functioning, and attention/concentration.

  5. Subjective well-being [ Time Frame: At 8-week assessment point ]
    Subjective well-being has at least three components: positive affective appraisal, negative affective appraisal, and life satisfaction. Composite scores for well-being will be calculated using scores obtained on Positive and Negative Affect Schedule (PANAS) and the Satisfaction with Life Scale (SWLS).

  6. Pain Catastrophizing Scale (PCS) [ Time Frame: At 8-week assessment point ]
    . Catastrophizing will be measured using the Pain Catastrophizing Scale (PCS).144 The PCS contains 13 statements regarding various beliefs about pain. A total score is obtained by summing the responses to all items.

  7. Patient Health Questionnaire 9-item (PHQ-9): [ Time Frame: At 8-week assessment point ]
    The PHQ-9 is a 9-item multipurpose instrument that has utility for screening, diagnosing, monitoring, and measuring the severity of depression.

  8. Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: At 8-week assessment point ]
    The GAD-7 is a 7-item measure of anxiety. It has good reliability, criterion, construct, and factorial validity. It has a sensitivity of 89% and specificity of 82% for generalized anxiety disorder.

  9. Perceived Stress Scale (PSS) [ Time Frame: At 8-week assessment point ]
    The 10-item PSS will be used evaluate an individual's assessment of stress. Participants rate stress on a numeric rating scale from 0 to 10 where higher scores reflect higher levels of stress. Total scores range from 0 to 100.

  10. Six-Minute Walk Test (6MWT) [ Time Frame: At 8-week assessment point ]
    The 6MWT measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. Participants are instructed to walk as far as possible, but allowed to self-pace and rest as needed.

  11. Sit-to-Stand Test [ Time Frame: At 8-week assessment point ]
    Patients are instructed to stand up 5 times from a chair without arms as fast as possible. The test is repeated twice as this improves reliability. Average time is calculated in seconds.

  12. Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method [ Time Frame: At 8-week assessment point ]
    The Blackburn lab collaborated with Biorad to develop a highly sensitive, quantitative and high throughput droplet digital PCR (ddPCR) method to measure telomerase activity in unstimulated PBMCs. This new method has over 10-fold increased sensitivity and over 5-fold increased throughput compared to the currently used gel method.

  13. Telomere length [ Time Frame: At 1 year assessment point ]
    The DNA will then be analyzed for telomere length using a quantitative polymerase chain reaction (PCR) measurement assay adapted from the methods described by Cawthon with modifications by Lin (Co-I).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03304613

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Contact: Afton Hassett, Psy.D. 734-998-6939

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United States, Michigan
Back & Pain Center, University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Joseph Long    734-763-5226   
Sponsors and Collaborators
University of Michigan

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Responsible Party: Afton Hassett, Psy.D., Associate Research Scientist, University of Michigan Identifier: NCT03304613     History of Changes
Other Study ID Numbers: HUM00124722
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases