Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2005-06-30
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBT for Insomnia (CBT-I)
Cognitive-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 Insomnia (CBT-I)
CBT for Pain (CBT-P)
Cognitive-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 Pain (CBT-P)
CBT for Insomnia & Pain (CBT-I/P)
Combined Cognitive-Behavioral Therapy for Insomnia \& Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.
CBT for Insomnia (CBT-I)
CBT for Pain (CBT-P)
Wait-List Control (WL)
Waitlist Control condition (WL) with no contact during the intervention period.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CBT for Insomnia (CBT-I)
CBT for Pain (CBT-P)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
35 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Institutes of Health (NIH)
NIH
National Institute of Nursing Research (NINR)
NIH
University of Rochester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wilfred Pigeon
Asst Prof
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wilfred R. Pigeon, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Rochester Sleep Research Laboratory
Rochester, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R21AG023956; R24AG031089
Identifier Type: OTHER
Identifier Source: secondary_id
160743209
Identifier Type: -
Identifier Source: org_study_id