Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study (SPIN-CWP)

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University of Missouri (MU)

Status

Completed

Conditions

Chronic Insomnia
Chronic Widespread Pain

Treatments

Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain

Study type

Interventional

Funder types

Other

Identifiers

NCT02688569
2004488HS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

CBT-CWP
Experimental group
Description:
Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)
Treatment:
Behavioral: Cognitive Behavioral Therapy for Chronic Widespread Pain
Control
No Intervention group
Description:
Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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