Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rochester, New York 14642


Purpose:

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 summary:

The investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia & pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity. The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function. The investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.


Criteria:

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


NCT ID:

NCT00127790


Primary Contact:

Principal Investigator
Wilfred R. Pigeon, Ph.D
University of Rochester


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.