Social & Behavioral Rhythms in Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Activity Rhythms - Actigraphy Assessment
研究概览
简要总结
Behavioral and biological rhythms are essential for health. No study evaluated behavioral rhythm or rhythm regulation in chronic pain and how this impacts functioning. The objective of this study is to gather preliminary data, focusing on the role of behavioral rhythms in the cardinal clinical symptoms of chronic pain (i.e., sleep, fatigue, and mood). Additionally, this study will provide preliminary data for the feasibility and acceptability of the therapeutic approach aiming to strengthen behavioral rhythms for patients with chronic pain.
详细描述
The overall goal of this study is to gather preliminary data, focusing on behavioral rhythms in patients with chronic pain as well as the relationship between behavioral rhythms and the pain-related clinical symptoms. Additionally, this study will provide preliminary data for the feasibility, acceptability, and treatment effects of repurposing interpersonal social rhythm therapy (IPSRT) along with light therapy for patients with chronic pain exhibiting significant rhythm dysregulation, sleep disturbances, and mood symptoms. The deliverables at the end of this project will include 1) preliminary evidence concerning the prevalence of behavioral rhythm disturbances in patients with chronic pain; 2) the association between such behavioral rhythm disruptions and the symptom cluster of pain-sleep-fatigue-mood; 3) feasibility and acceptability of a prototype IPSRT repurposed for chronic pain patients along with bright light therapy. The specific aims of this proposed study are as follows:
Aim 1: To evaluate regularity of social and behavioral rhythms (SBR), disruption of circadian activity rhythms (CAR), and the relationship of SBR and CAR with clinical symptoms of pain-sleep-fatigue-mood in chronic pain patients compared to healthy control.
Hypothesis 1: Patients with chronic pain will show high degrees of SBR and CAR disruption compared to controls.
Hypothesis 2: Patients with increasingly dysregulated SBR and attenuated CAR will exhibit worse clinical symptoms.
Hypothesis 3: SBR will be associated with CAR in patients with chronic pain and in controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants (patients and controls):
- •18-65 years of age with
- •reading/writing proficiency in English.
- •Patients must:
- •have had persistent pain for more than 1-year at a consistent body part or diffuse body pain (e.g., fibromyalgia) that is stable rather than progressive in nature
- •report experiencing pain for more than 70% of the waking hours in any given week
- •under current medical care by a physician for a pain diagnosis
- •able remain stable on any of their medication (as prescribed) for the duration of the 8-day evaluation involved in Aim 1
- •Control subjects must:
- •be pain-free for the past 1-year
- •no prior treatment for a chronic pain condition
- •in overall good health
- •Patients must:
- •have current symptoms of insomnia (Insomnia Severity Index (ISI), ISI>8)
- •have depression (Patient Health Questionnaire-9, PHQ-9>10)
- •exhibit significant circadian activity rhythm dysregulation during the 8-day evaluation (defined as Amplitude<0.9)
- •Control subjects must:
- •be pain-free for the past 1-year
- •no prior treatment for a chronic pain condition
- •in overall good health
排除标准
- •patients/controls who underwent surgery in the last 6-months
- •shift workers
- •current drug abuse/dependence
- •receiving treatment in methadone clinic
- •current cardiac conditions
- •untreated sleep apnea
- •untreated restless legs syndrome
- •neurodegenerative disease
- •bipolar disorder
- •psychosis
- •suicidal ideation
- •have changed time-zones in the last 7 days
- •experienced a significant life change in the last month (e.g., death in the family, loss of job, traumatic event)
- •patients/controls who underwent surgery in the last 6-months
- •shift workers
- •current drug abuse/dependence
- •receiving treatment in methadone clinic
- •current cardiac conditions
- •untreated sleep apnea
- •untreated restless legs syndrome
- •neurodegenerative disease
- •bipolar disorder
- •psychosis
- •suicidal ideation
- •have changed time-zones in the last 7 days
- •experienced a significant life change in the last month (e.g., death in the family, loss of job, traumatic event)
- •receiving psychotherapy
- •significant photophobia
- •chronic migraines
研究组 & 干预措施
Pain Patients
40 Pain Patients will be screened for social and behavioral rhythms with no treatment involved. All patients will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.
Controls
40 Controls will be screened for social and behavioral rhythms with no treatment involved. All Controls will be evaluated an Actigraph by Philips for 8-days to assess sleep and activity.
Treatment
10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.
干预措施: Interpersonal Social Rhythms Psychotherapy (Behavioral)
Treatment
10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.
干预措施: Bright Light Device (Other)
结局指标
主要结局
Activity Rhythms - Actigraphy Assessment
时间窗: Baseline
Collected continuously for 8 days at baseline
Change in Activity Rhythms - Actigraphy Assessment
时间窗: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Collected continuously for 8 days at baseline, at Pre-treatment for those receiving the therapy (within 2 weeks of Baseline assessment) as well as at mid point of therapy (4-weeks) and post therapy (8-weeks)
次要结局
- Insomnia Severity index(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Social Rhythms Metric(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
- Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning(Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks))
研究者
Ariel Neikrug
Postdoctoral Fellow
University of Utah