Treatment of Insomnia Secondary to Chronic Pain
CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
5 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2005
CompletedFirst Posted
Study publicly available on registry
August 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
October 17, 2012
CompletedOctober 17, 2012
September 1, 2012
3.3 years
August 3, 2005
June 12, 2012
September 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
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)
Secondary Outcomes (1)
Depression Severity
Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
Study Arms (4)
CBT for Insomnia (CBT-I)
ACTIVE COMPARATORCognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
CBT for Pain (CBT-P)
ACTIVE COMPARATORCognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
CBT for Insomnia & Pain (CBT-I/P)
EXPERIMENTALCombined Cognitive-Behavioral Therapy for Insomnia \& Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.
Wait-List Control (WL)
NO INTERVENTIONWaitlist Control condition (WL) with no contact during the intervention period.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester Sleep Research Laboratory
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The foremost limitation of this pilot study is its small sample size, particularly for a four-arm design. Accordingly, a cautious approach to the interpretation of the findings is warranted.
Results Point of Contact
- Title
- Wilfred Pigeon, PhD
- Organization
- Universityy of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Wilfred R. Pigeon, Ph.D
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst Prof
Study Record Dates
First Submitted
August 3, 2005
First Posted
August 8, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
October 17, 2012
Results First Posted
October 17, 2012
Record last verified: 2012-09