Treatment of Insomnia Secondary to Chronic Pain

Pain Clinical Trial

Official title:

CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127790
• Other study ID #: 160743209
• Secondary ID: F32NS049789K23NR
• Status: Completed
• Phase: N/A
• First received: August 3, 2005
• Last updated: September 14, 2012
• Start date: June 2005
• Est. completion date: November 2008

Study information

• Verified date: September 2012
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia
• Pain

Intervention

Behavioral:
• CBT for Insomnia (CBT-I)

• CBT for Pain (CBT-P)

Locations

Country	Name	City	State
United States	University of Rochester Sleep Research Laboratory	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity	Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.	Pre to Post Treatment Change (Over an average of approximately 10 weeks)	No
Primary	Pain Severity	Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.	Pre to Post Treatment Change (Over an average of approximately 10 weeks)	No
Primary	IL-6	Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.	Pre to Post Treatment Change (Over an average of approximately 10 weeks)	No
Secondary	Depression Severity	Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.	Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)	No