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| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2005 | ||||
| Last Updated Date | April 14, 2008 | ||||
| Start Date ICMJE | June 2005 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00127790 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Assessments will also be made for mood, quality of life, and personality factors. [ Time Frame: October 2008 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Assessments will also be made for mood, quality of life, and personality factors. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Insomnia Secondary to Chronic Pain | ||||
| Official Title ICMJE | CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Cognitive-Behavioral Treatment for Insomnia and/or Pain | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 44 | ||||
| Estimated Completion Date | November 2008 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00127790 | ||||
| Responsible Party | Wilfred R. Pigeon, Ph.D./Primary Investigator, University of Rochester | ||||
| Study ID Numbers ICMJE | 160743209, 10274 (IRB#), NS049789-02 | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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