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Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

CompletedNot applicableNCT02688569
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)

This randomized controlled clinical trial will examine the effects of Cognitive Behavioral Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia. Specific Aims: 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with comorbid CWP and insomnia. 2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue compared to the waitlist control (WLC). 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health compared WLC. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV), CS (thermal response) and neural plasticity (brain function and structure) - compared to WLC.

Study details

Official title
Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
Interventions
  • Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain
Sponsor
University of Missouri-Columbia
Start date
2016-10
Primary completion
2022-12
Sex
All
Age range
from 18 Years
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: * 18+ years old * Be willing to be randomly assigned to either the treatment condition or the control condition * Be able to read and understand English * Have Chronic Widespread Pain (CWP) and Insomnia based on the criteria below: o CWP: * Complaints of pain in upper, lower body, on both sides and the back that lasts for 3+ months. * Not explained by other illnesses except somatic disorders. o Insomnia: * Insomnia complaints for 6+ months * Occur despite adequate opportunity and circumstances for sleep * Consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep * Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia * Baseline diaries indicate \>30 minutes of sleep latency or wake after sleep onset combined on 6+ nights. Exclusion Criteria: * Be unable to provide informed consent * Be unwilling to undergo randomization * Be unable to complete forms and implement treatment due to cognitive impairment (Mini Mental State Examination \<26) * Sleep disorder other than insomnia (i.e., sleep apnea \[apnea/hypopnea index, AHI \>15\]; Periodic Limb Movement Disorder-PLMD \[myoclonus arousals per hour \>15\]) * bipolar or seizure disorder * other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders) * severe untreated psychiatric comorbidity that renders randomization unethical, * psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep * participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue, or mood outside the current study, * internal metal objects or electrical devices * pregnancy

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02688569