Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

NCT ID: NCT00321451

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

4 biweekly outpatient sessions with sleep psychologist

2

Group Type: SHAM_COMPARATOR

Pseudo-desensitization procedure

Intervention Type: BEHAVIORAL

4 biweekly outpatient visits with sleep psychologist

3

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

3 outpatient visits with study physician

Interventions

Cognitive behavioral therapy for insomnia

4 biweekly outpatient sessions with sleep psychologist

Intervention Type: BEHAVIORAL

Pseudo-desensitization procedure

4 biweekly outpatient visits with sleep psychologist

Intervention Type: BEHAVIORAL

Usual care

3 outpatient visits with study physician

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack D. Edinger, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16314551 (View on PubMed)

Other Identifiers

R01AR052368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00011861

Identifier Type: -

Identifier Source: org_study_id