Clinical trial NCT03022643: Social & Behavioral Rhythms in Chronic Pain
Official title: Social & Behavioral Rhythms in Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Aim 2: To assess feasibility and acceptance of interpersonal social rhythm therapy repurposed for chronic pain patient population along with bright light therapy provided to patients exhibiting SBR disruption with significant sleep and mood symptoms.

Hypothesis 1: The IPSRT will be well tolerated and accepted by the patients

Hypothesis 2: Descriptive data will suggest improvement of SBR, CAR, and the pain-related symptoms and functioning.

Eligibility criteria: Inclusion Criteria:

All participants (patients and controls):

* 18-65 years of age with
* reading/writing proficiency in English.

Aim 1:

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

Aim 2:

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

Exclusion Criteria:

Aim 1:

* patients/controls who underwent surgery in the last 6-months
* shift workers
* dementia
* 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)

Aim 2:

* patients/controls who underwent surgery in the last 6-months
* shift workers
* dementia
* 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

Primary outcomes:
measure: Activity Rhythms - Actigraphy Assessment
timeFrame: Baseline
measure: Change in Activity Rhythms - Actigraphy Assessment
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary outcomes:
measure: Insomnia Severity index
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Social Rhythms Metric
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
measure: Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning
timeFrame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Ariel B Neikrug, PhD
role: PRINCIPAL_INVESTIGATOR
References: