Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
62 participants
INTERVENTIONAL
2016-11-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stabilizing Behavioral Rhythms to Improve Mental Health
NCT03152864
Mindfulness Based Chronic Pain Management: A Pilot Study
NCT01886885
Cognitive Behavioral Therapy and Light Therapy
NCT05337943
Acupuncture Analgesia in Relation to Psychiatric Comorbidity
NCT00307788
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans
NCT04724694
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 interventions assigned to this group
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.
No interventions assigned to this group
Treatment
10 patients from the original 40 will receive Interpersonal Social Rhythms Psychotherapy and Bright Light Device therapy to improve social and behavioral rhythms.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ariel Neikrug
Postdoctoral Fellow
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ariel B Neikrug, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
094507
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.