Social & Behavioral Rhythms in Chronic Pain
CompletedNot applicableNCT03022643
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Social & Behavioral Rhythms in Chronic Pain
- Conditions
- Interventions
- Behavioral: Interpersonal Social Rhythms Psychotherapy
- Other: Bright Light Device
- Sponsor
- University of Utah
- Start date
- 2016-11
- Primary completion
- 2017-06
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03022643