Social & Behavioral Rhythms in Chronic Pain

Chronic Pain Clinical Trial

Official title:

Social & Behavioral Rhythms in Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022643
• Other study ID #: 094507
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Interpersonal Social Rhythms Psychotherapy
The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.

Other:
• Bright Light Device
All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity Rhythms - Actigraphy Assessment	Collected continuously for 8 days at baseline	Baseline
Primary	Change in Activity Rhythms - Actigraphy Assessment	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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Insomnia Severity index	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Social Rhythms Metric	Collected continuously at baseline (during the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
Secondary	Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning	Collected at baseline (prior the 8-day assessment), 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)	Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)