N/A
N=21
Treatment of Insomnia Secondary to Chronic Pain
Insomnia · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00127790 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Insomnia Severity — 6.0; 12.8; 4.4; 13.0 units on a scale — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT for Insomnia (CBT-I) (Behavioral); CBT for Pain (CBT-P) (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity |
6.0; 12.8; 4.4; 13.0 | 0.010 sig |
| PRIMARY Pain Severity |
11.0; 6.2; 8.8; 7.5 | 0.33 |
| PRIMARY IL-6 |
0.7; 1.6; 1.2; 1.2 | 0.063 |
| SECONDARY Depression Severity |
2.3; 10.2; 4.4; 17.6 | 0.016 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00127790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.