Resilience Skills Self-Management for Chronic Pain.
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|ClinicalTrials.gov Identifier: NCT03304613|
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : December 27, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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)|
|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|
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
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT03304613
|Contact: Afton Hassett, Psy.D.||firstname.lastname@example.org|
|United States, Michigan|
|Back & Pain Center, University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Contact: Joseph Long 734-763-5226 email@example.com|