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Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

NCT02688569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Widespread Pain
  • Chronic Insomnia

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Chronic Widespread Pain

CBT-CWP in this study involves 4 sessions of one-hour non-drug behavioral intervention. Session 1 involves education about pain and insomnia and the relationship between the two. Participants will also learn sleep hygiene and stimulus control skills. Session 3 involves teaching participants skills to limit non-sleep time in bed and thus increase sleep efficiency. Participants will also learn the relationship between pain and activity. Session 4 involves teaching participants cognitive restructuring and mindfulness skills to manage maladaptive thoughts related to pain and insomnia. Participants will also review the skills they learned and discuss the maintenance of treatment gains.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Christina S McCrae, Ph.D. · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688569 on ClinicalTrials.gov