Clinical trial NCT00127790: Treatment of Insomnia Secondary to Chronic Pain
Official title: CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Pain
Keywords: Insomnia
Sleep
Pain
Pain, Chronic
Behavior Therapy
CBT
CBT-I
cognitive-behavioral
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2005-08-08
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Insomnia Severity
timeFrame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
measure: Pain Severity
timeFrame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
measure: IL-6
timeFrame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Secondary outcomes:
measure: Depression Severity
timeFrame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Sleep Research Laboratory
state: New York
Study officials:
affiliation: University of Rochester
name: Wilfred R. Pigeon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: