Treatment of Insomnia Secondary to Chronic Pain
CompletedNot applicableNCT00127790
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)
Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.
Study details
- Official title
- CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
- Interventions
- Behavioral: CBT for Insomnia (CBT-I)
- Behavioral: CBT for Pain (CBT-P)
- Sponsor
- University of Rochester
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); National Institute of Nursing Research (NINR)
- Start date
- 2005-06
- Primary completion
- 2008-10
- Sex
- All
- Age range
- from 35 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Ages 35-75 * Chronic non-malignant painful condition of the spine of \> 6 months duration * Insomnia (\> 30 minutes sleep latency and/or wake after sleep onset time for \> 3 days/week for \> 6 months) * Insomnia developed after the onset of the painful condition * Preferred sleep phase between 10:00 p.m. and 8:00 am * On stable medical regimen for medical and pain conditions (no surgery planned) * Willingness to discontinue hypnotic medications Exclusion Criteria: * Unstable medical or psychiatric illness * History of seizures * Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence * Symptoms suggestive of sleep disorders other than insomnia * Polysomnographic data indicating sleep disorders other than insomnia * Inadequate language comprehension * Fibromyalgia * Pregnancy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00127790