Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Behavioral Insomnia Therapy With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321451
• Other study ID #: Pro00011861
• Secondary ID: R01AR052368
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 2, 2006
• Last updated: January 28, 2016
• Start date: May 2006
• Est. completion date: February 2011

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy for insomnia
4 biweekly outpatient sessions with sleep psychologist
• Pseudo-desensitization procedure
4 biweekly outpatient visits with sleep psychologist

Other:
• Usual care
3 outpatient visits with study physician

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total wake time		Measured immediately and 6 months post-treatment	No
Primary	Total sleep time		Measured immediately and 6 months post-treatment	No
Primary	Sleep efficiency		Measured immediately and 6 months post-treatment	No
Secondary	Sleep onset latency		Measured immediately and 6 months post-treatment	No
Secondary	Wake time after sleep onset		Measured immediately and 6 months post-treatment	No
Secondary	Score on an insomnia rating scale		Measured immediately and 6 months post-treatment	No
Secondary	Score on a fatigue rating scale		Measured immediately and 6 months post-treatment	No
Secondary	Score on a mood rating scale		Measured immediately and 6 months post-treatment	No
Secondary	Subjective pain ratings		Measured immediately and 6 months post-treatment	No
Secondary	Score on a health-related quality of life scale		Measured immediately and 6 months post-treatment	No