Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00321451
First received: May 2, 2006
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive behavioral therapy for insomnia
Behavioral: Pseudo-desensitization procedure
Other: Usual care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Insomnia Therapy With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Total wake time [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Total sleep time [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Sleep efficiency [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep onset latency [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Wake time after sleep onset [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Score on an insomnia rating scale [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Score on a fatigue rating scale [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Score on a mood rating scale [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Subjective pain ratings [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]
  • Score on a health-related quality of life scale [ Time Frame: Measured immediately and 6 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: May 2006
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Cognitive behavioral therapy for insomnia
4 biweekly outpatient sessions with sleep psychologist
Sham Comparator: 2 Behavioral: Pseudo-desensitization procedure
4 biweekly outpatient visits with sleep psychologist
Active Comparator: 3 Other: Usual care
3 outpatient visits with study physician

Detailed Description:

FM is a debilitating condition that can lead to impaired occupational and social functioning, disability, and increased health care utilization. FM symptoms vary among individuals, but they typically include chronic widespread pain, persistent daytime fatigue, sleep disturbances, low mood, and loss of stamina. The cause of FM remains unknown, and current treatment involves symptom-focused interventions such as antidepressants, behavioral stress management, coping skills training, and exercise programs. However, there are no interventions specifically designed to reduce sleep disturbances in people with FM.

Past research has shown that individuals with FM experience the same behavioral and psychological factors that individuals suffering from insomnia experience. Cognitive behavioral insomnia therapy, a form of psychotherapy that aims to eliminate factors that disrupt sleep, may prove useful for people with FM. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving FM-related pain, fatigue, mood, and quality of life among individuals with FM. The study will also examine the use of sleep electroencephalogram (EEG) as a means to measure improvements in FM symptoms.

This study will last about 9 months and will include approximately 16 study visits. An initial 2-week screening period will include a physical examination, blood collection, a mental status exam, a tender-point exam, a sleep history questionnaire, and structured sleep and psychiatric interviews. Participants will complete a 1-week sleep log and one overnight polysomnogram test, in which several body functions (e.g., brain activity, eye movement, heart rate, etc.) are recorded. If an FM diagnosis is confirmed, an additional 2-week assessment period will take place, followed by an 8-week treatment period. During treatment, participants will be randomly assigned to one of the following three treatment groups: 1) usual FM care (medical advice and medication prescription), 2) usual FM care plus psychological treatment to decrease insomnia, and 3) usual FM care plus placebo psychological treatment to decrease insomnia. Groups 2 and 3 will attend four bi-weekly individual therapy sessions with a sleep psychologist. Participants will meet with a rheumatologist at least once. Throughout treatment, nightly sleep logs and medication questionnaires will be completed, and participants will wear a wrist-watch sized device that will record their day- and night-time activity. A therapy evaluation questionnaire will be completed during the first and last weeks of treatment and an outcome questionnaire packet will be completed after 4 weeks of treatment. All participants will be evaluated following the end of treatment and again 6 months later.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reside in or around Durham, NC
  • History of insomnia complaints for more than 1 month
  • Diagnosis of primary FM
  • Diagnosis of insomnia

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321451

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Jack D. Edinger, PhD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00321451     History of Changes
Other Study ID Numbers: Pro00011861, R01AR052368
Study First Received: May 2, 2006
Last Updated: November 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
insomnia
cognitive behavior therapy

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014