Stress, Psychological Clinical Trial
Official title:
Neurobiological Mechanisms of Stress in Youth With Chronic Widespread Pain
Chronic widespread pain (CWP) is a common chronic pain condition in youth and often associated with significant pain-related and psychosocial impairment. Understanding the neurobiological mechanisms that may underlie pediatric chronic pain and pain-related impairment can inform future treatments to ameliorate patients' suffering, making it a critical area of empirical investigation.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility | Chronic Widespread Pain (CWP) group: Inclusion Criteria: - Between ages 11-17 years - Referred to the Boston Children's Hospital Pain Treatment Service for evaluation of a CWP condition with duration > 3 months - Right-handed Exclusion Criteria: - Inability to speak sufficient English to complete questionnaires - Severe cognitive impairment - Prescription steroidal (interference with cortisol measures) or psychotropic medication - Any other chronic pain diagnosis (e.g., migraines, abdominal pain, CRPS) - fMRI contraindications (e.g., dental appliances) Healthy Control (HC) group: Inclusion Criteria: - Between ages 11-17 years - Right-handed Exclusion Criteria: - Inability to speak sufficient English to complete questionnaires - Severe cognitive impairment - Prescription steroidal (interference with cortisol measures) or psychotropic medication - Any chronic pain diagnosis - Presence of documented chronic (> 3 months) medical condition with an identifiable, organic cause (e.g., diabetes, cystic fibrosis) - fMRI contraindications (e.g., dental appliances) |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Treatment Engagement | measured via participant self-report of treatment as usual (e.g., engagement in physical therapy, cognitive-behavioral therapy, acupuncture, etc.). Observational measure without metrics for risk or impairment. | baseline and 4-month follow-up | |
Other | Change in Adverse Childhood Experiences (ACEs) exposure | measured via Childhood Trust Events Scale (CTES). Items on this measure are coded dichotomously (0 = no; 1 = yes) and will be summed to provide a total metric of ACEs exposure (range: 0-26). | baseline and 4-month follow-up | |
Other | Change in Psychological Stress | measured via Patient Reported Outcome Measurement Information System (PROMIS) psychological stress scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of psychological stress. | baseline and 4-month follow-up | |
Other | Change in Anxiety | measured via Patient Reported Outcome Measurement Information System (PROMIS) anxiety scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of anxiety. | baseline and 4-month follow-up | |
Other | Change in Depression | measured via Patient Reported Outcome Measurement Information System (PROMIS) depression scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater amounts of depressive symptoms. | baseline and 4-month follow-up | |
Primary | Hippocampal Functioning | measured via fMRI | baseline | |
Primary | Change in Morning Cortisol | measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, morning cortisol will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load. | baseline and 4-month follow-up | |
Primary | Change in Dehydroepiandrosterone (DHEA) | measured via 2 samples of saliva taken via passive drool over the course of two days. After analysis, DHEA will be dichotomously coded with participants receiving a "1" if they score over one standard deviation above the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load. | baseline and 4-month follow-up | |
Primary | Change in Flattened Cortisol | measured via 10 samples of saliva taken via passive drool over the course of two days. After analysis, the presence of cortisol will be dichotomously coded with participants receiving a "1" if the change in cortisol levels across the day fell at or below one standard deviation below the mean. Coding will them be combined to formulate an allostatic load risk ratio, with higher scores indicating greater risk for allostatic load. | baseline and 4-month follow-up | |
Primary | Change in Blood Pressure | measured via blood pressure cuff by trained nurse. Results will be coded to capture levels that fall in the "normal", "prehypertension" and "hypertension" range with individuals scoring in the latter two ranges receiving a coding of "1" to be included in the allostatic load risk composite measure. Scoring of blood pressure ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender. | baseline and 4-month follow-up | |
Primary | Change in Body-Mass Index (BMI) | measured via height and weight (in cm and kg) by a trained nurse. Results will be coded to capture individuals that score in the "underweight", "normal", "overweight" and "obese" ranges with individuals falling in all categories but "normal" receiving a coding of "1" to be included in the allostatic load risk ratio. Scoring of BMI ranges will be done using ezbmi- calculates deviation from expected BP/BMI by age/gender. | baseline and 4-month follow-up | |
Primary | Change in Waist-Hip Ratio (WHR) | measured via tape measure around the smallest part of the waist and the widest part of the hips by a trained research coordinator. Results (waist measurement/hip measurement) will be coded dichotomously with individuals scoring a "1" whose WHR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio. | baseline and 4-month follow-up | |
Primary | Change in Heart Rate (HR) | measured via pulse taken by a trained nurse. Results will be coded dichotomously with individuals scoring a "1" whose HR falls greater than or equal to one standard deviation above the mean of the sample. This scoring will also be included in the larger allostatic load risk ratio. | baseline and 4-month follow-up | |
Secondary | Change in Pain Intensity | measured via numeric rating scale (range: 0-10). Higher rating indicates more intense pain. | baseline and 4-month follow-up | |
Secondary | Change in Functional Disability | measured via self-report Functional Disability Inventory (range: 0-60). Higher rating indicates greater functional disability. | baseline and 4-month follow-up | |
Secondary | Change in Sleep | measured via Patient Reported Outcome Measurement Information System (PROMIS) sleep disturbance scale short-form (8a). Raw scores are converted to T-scores (range: 0-100). Higher rating indicates greater impairment in sleep. | baseline and 4-month follow-up |
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