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Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

NCT00321451 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2016-01-29

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Sleep Initiation and Maintenance Disorders

Interventions

BEHAVIORAL

Cognitive behavioral therapy for insomnia

4 biweekly outpatient sessions with sleep psychologist

BEHAVIORAL

Pseudo-desensitization procedure

4 biweekly outpatient visits with sleep psychologist

OTHER

Usual care

3 outpatient visits with study physician

Sponsors & Collaborators

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

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Jack D. Edinger, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321451 on ClinicalTrials.gov