- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00321451
Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Behavioral Insomnia Therapy With Fibromyalgia
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
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4 biweekly outpatient sessions with sleep psychologist
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Sham-komparator: 2
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4 biweekly outpatient visits with sleep psychologist
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Aktiv komparator: 3
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3 outpatient visits with study physician
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total wake time
Tidsramme: Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
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Total sleep time
Tidsramme: Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
|
Sleep efficiency
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Sleep onset latency
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Wake time after sleep onset
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
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Score on an insomnia rating scale
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a fatigue rating scale
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a mood rating scale
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Subjective pain ratings
Tidsramme: Measured immediately and 6 months post-treatment
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Measured immediately and 6 months post-treatment
|
Score on a health-related quality of life scale
Tidsramme: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jack D. Edinger, PhD, Duke University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00011861
- R01AR052368 (U.S. NIH-bevilling/kontrakt)
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