Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000397
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
1999-11-03
Brief Title:
Behavioral Insomnia Therapy for Fibromyalgia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Behavioral Insomnia Therapy for Fibromyalgia Patients
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study tests the effectiveness of a nondrug treatment for the insomnia that often occurs in people with fibromyalgia The treatment is a type of psychotherapy called cognitive-behavioral therapy Cognitive-behavioral therapy combines cognitive therapy which can modify or eliminate thought patterns contributing to the persons symptoms and behavioral therapy which aims to help the person change his or her behavior
Detailed Description:
Fibromyalgia FM is a prevalent and debilitating condition that contributes to impaired occupational and social functioning and increased disability among affected individuals The vast majority of people with FM experience persistent sleep disturbances eg onset difficulty repeated or extended awakenings nonrestorative sleep that worsen other FM-related symptoms eg chronic pain fatigue and sustain their general dysfunction Pharmacologic treatments eg antidepressants hypnotics may reduce symptoms for some people with FM but many FM patients display little enduring improvement in their sleep and other FM-related symptoms in response to such agents
Our clinical observations and initial pilot work suggest that factors common among other insomnia subtypes such as conditioned bedtime arousal erratic sleepwake scheduling and spending too much time in bed likely perpetuate the sleep problems of these medication-refractory FM patients Over the past decade we have developed refined and repeatedly tested a cognitive-behavioral therapy CBT that has proven effective for reducing sleep disturbances perpetuated by such underlying cognitivebehavioral mechanisms The major objectives of this project are to conduct a prospective randomized clinical trial to confirm these preliminary findings and to determine the efficacy of CBT insomnia treatment for interrupting the disturbed nocturnal sleep and daytime pain fatigue and distress symptom complex that defines FM
One arm of this studys three-by-four factorial design will compare CBT with both a contact control treatment and standard care The other arm in the design is a repeated-measures factor consisting of four time points ie baseline mid-treatment post-treatment and 6-month follow-up periods at which we will assess outcome We will assess participants at all four time points with objective wrist actigraphy and subjective sleep logs Insomnia Symptom Questionnaire measures of sleep improvements measures of subjective pain and questionnaires that assess mood State-Trait Anxiety and Beck Depression Scales and general quality of life SF-36 We will conduct multivariate statistical analyses and tests of clinical significance with these various measures We will also conduct exploratory analyses to determine if polysomnographically-derived sleep measures obtained prior to treatment correlate with initial levels of pain and distress or eventual treatment outcome
Results should provide information about the usefulness of CBT for treating FM-related sleep difficulties Results should also improve understanding of the FM syndrome in general and provide new information about the potential role of behavioral therapy in the overall management of this disorder
Individuals interested in participating in this study should live within reasonable commuting distance from the Duke University Medical Center Durham NC because this research requires multiple outpatient visits for screening and treatment
Our clinical observations and initial pilot work suggest that factors common among other insomnia subtypes such as conditioned bedtime arousal erratic sleepwake scheduling and spending too much time in bed likely perpetuate the sleep problems of these medication-refractory FM patients Over the past decade we have developed refined and repeatedly tested a cognitive-behavioral therapy CBT that has proven effective for reducing sleep disturbances perpetuated by such underlying cognitivebehavioral mechanisms The major objectives of this project are to conduct a prospective randomized clinical trial to confirm these preliminary findings and to determine the efficacy of CBT insomnia treatment for interrupting the disturbed nocturnal sleep and daytime pain fatigue and distress symptom complex that defines FM
One arm of this studys three-by-four factorial design will compare CBT with both a contact control treatment and standard care The other arm in the design is a repeated-measures factor consisting of four time points ie baseline mid-treatment post-treatment and 6-month follow-up periods at which we will assess outcome We will assess participants at all four time points with objective wrist actigraphy and subjective sleep logs Insomnia Symptom Questionnaire measures of sleep improvements measures of subjective pain and questionnaires that assess mood State-Trait Anxiety and Beck Depression Scales and general quality of life SF-36 We will conduct multivariate statistical analyses and tests of clinical significance with these various measures We will also conduct exploratory analyses to determine if polysomnographically-derived sleep measures obtained prior to treatment correlate with initial levels of pain and distress or eventual treatment outcome
Results should provide information about the usefulness of CBT for treating FM-related sleep difficulties Results should also improve understanding of the FM syndrome in general and provide new information about the potential role of behavioral therapy in the overall management of this disorder
Individuals interested in participating in this study should live within reasonable commuting distance from the Duke University Medical Center Durham NC because this research requires multiple outpatient visits for screening and treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-039 | US NIH GrantContract | None | httpsreporternihgovquickSearchR21AR046094 |
| R21AR046094 | NIH | None | None |