Columbia, Missouri 65203

  • Chronic Insomnia

Purpose:

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 summary:

This randomized controlled clinical trial will examine the effects of CBT in patients with chronic widespread pain and insomnia. Sample will include 20 patients ([18]-65 years) who satisfy criteria for chronic widespread pain and insomnia. Participants will be randomly assigned to CBT or waitlist control. All participants randomized to the cognitive-behavioral interventions will receive 4 treatment sessions (~50 minutes each). Baseline, posttreatment, [& 3-mo.] follow-up assessments will include measures of sleep, pain, thermal pain response, heart rate variability, brain structure and functions, affect, cognitive functioning, cardiovascular health, and substance use.


Criteria:

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


NCT ID:

NCT02688569


Primary Contact:

Principal Investigator
Christina S McCrae, Ph.D.
University of Missouri-Columbia

Wai Sze Chan, Ph.D.
Phone: 5738847487
Email: chanw@health.missouri.edu


Backup Contact:

N/A


Location Contact:

Columbia, Missouri 65203
United States

Jason Lackey, BS
Phone: 573-884-7362
Email: lackeyj@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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