Social & Behavioral Rhythms in Chronic Pain

March 13, 2019 updated by: Ariel Neikrug, University of Utah
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
No Intervention: 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.
Experimental: Treatment
10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.
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.
Other Names:
  • Re-Timer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Activity Rhythms - Actigraphy Assessment
Time Frame: Baseline
Collected continuously for 8 days at baseline
Baseline
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)
Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
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)
Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
Baseline, Pre-treatment (within 2 weeks of Baseline Assessment), Mid-Therapy (4-weeks), Post-treatment (8-weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ariel B Neikrug, PhD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 094507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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