Back & Pain Center, University of Michigan
Ann Arbor, Michigan, 48106, United States
NCT Number: NCT03304613
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
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Notify Me35 year–65 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48106, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Already noted.
Already noted.
Other names: PRISM
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).
University of Michigan
Other
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