Skip to main content
OpenTrials
Completed

NCT Number: NCT03022643

Social & Behavioral Rhythms in Chronic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Social Rhythms Psychotherapy

Behavioral

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.

Bright Light Device

Other

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.

Other names: Re-Timer

Primary outcomes

  1. Activity Rhythms - Actigraphy Assessment

    Time frame: Baseline

    Collected continuously for 8 days at baseline

  2. Change in Activity Rhythms - Actigraphy Assessment

    Time frame: 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)

Secondary outcomes

  1. Insomnia Severity index

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  3. Social Rhythms Metric

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  4. Sleep Disturbances: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Sleep disturbance

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  5. Sleep-Related Impairment: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for sleep related impairment

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  6. Fatigue: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Fatigue

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  7. Depression: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Depression

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  8. Anxiety: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Anxiety

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  9. Pain Behavior: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for Pain behavior

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  10. Pain Interference: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for pain interference

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

  11. Physical Functioning: Patient Reported Outcome Measurement System (PROMIS) Short-Form Measures for physical functioning

    Time frame: Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

    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)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2017
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.