Social & Behavioral Rhythms in Chronic Pain

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Interpersonal Social Rhythms Psychotherapy; Other: Bright Light Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03022643

094507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 3 patient groups

Pain Patients

No Intervention group

Description:

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

No Intervention group

Description:

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

Experimental group

Description:

10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.

Treatment:

Other: Bright Light Device

Behavioral: Interpersonal Social Rhythms Psychotherapy