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Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Behavioral Insomnia Therapy With Fibromyalgia

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00321451
Enrollment
111
Registered
2006-05-03
Start date
2006-05-31
Completion date
2011-02-28
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Sleep Initiation and Maintenance Disorders

Keywords

insomnia, cognitive behavior therapy

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.

Interventions

BEHAVIORALCognitive behavioral therapy for insomnia

4 biweekly outpatient sessions with sleep psychologist

BEHAVIORALPseudo-desensitization procedure

4 biweekly outpatient visits with sleep psychologist

OTHERUsual care

3 outpatient visits with study physician

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Total wake timeMeasured immediately and 6 months post-treatment
Total sleep timeMeasured immediately and 6 months post-treatment
Sleep efficiencyMeasured immediately and 6 months post-treatment

Secondary

MeasureTime frame
Score on a fatigue rating scaleMeasured immediately and 6 months post-treatment
Score on a mood rating scaleMeasured immediately and 6 months post-treatment
Sleep onset latencyMeasured immediately and 6 months post-treatment
Score on a health-related quality of life scaleMeasured immediately and 6 months post-treatment
Subjective pain ratingsMeasured immediately and 6 months post-treatment
Wake time after sleep onsetMeasured immediately and 6 months post-treatment
Score on an insomnia rating scaleMeasured immediately and 6 months post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026