Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Behavioral Insomnia Therapy With Fibromyalgia
2 other identifiers
interventional
111
1 country
1
Brief Summary
Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving other FM-related symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJanuary 29, 2016
January 1, 2016
4.8 years
May 2, 2006
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Total wake time
Measured immediately and 6 months post-treatment
Total sleep time
Measured immediately and 6 months post-treatment
Sleep efficiency
Measured immediately and 6 months post-treatment
Secondary Outcomes (7)
Sleep onset latency
Measured immediately and 6 months post-treatment
Wake time after sleep onset
Measured immediately and 6 months post-treatment
Score on an insomnia rating scale
Measured immediately and 6 months post-treatment
Score on a fatigue rating scale
Measured immediately and 6 months post-treatment
Score on a mood rating scale
Measured immediately and 6 months post-treatment
- +2 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
SHAM COMPARATOR3
ACTIVE COMPARATORInterventions
4 biweekly outpatient sessions with sleep psychologist
Eligibility Criteria
You may qualify if:
- Reside in or around Durham, NC
- History of insomnia complaints for more than 1 month
- Diagnosis of primary FM
- Diagnosis of insomnia
You may not qualify if:
- Terminal illness or acute serious medical illness
- Secondary FM or condition other than FM that seriously compromises sleep
- Current psychiatric illness or currently suicidal
- Substance abuse or dependence
- Other primary sleep disorder (e.g., sleep apnea or restless legs syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.
PMID: 16314551BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack D. Edinger, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2006
First Posted
May 3, 2006
Study Start
May 1, 2006
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
January 29, 2016
Record last verified: 2016-01