- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00321451
Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
Behavioral Insomnia Therapy With Fibromyalgia
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
|
4 biweekly outpatient sessions with sleep psychologist
|
Comparatore fittizio: 2
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4 biweekly outpatient visits with sleep psychologist
|
Comparatore attivo: 3
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3 outpatient visits with study physician
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Total wake time
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
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Total sleep time
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Sleep efficiency
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Sleep onset latency
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Wake time after sleep onset
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on an insomnia rating scale
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a fatigue rating scale
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a mood rating scale
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Subjective pain ratings
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Score on a health-related quality of life scale
Lasso di tempo: Measured immediately and 6 months post-treatment
|
Measured immediately and 6 months post-treatment
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jack D. Edinger, PhD, Duke University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del sistema nervoso
- Disturbi del sonno, intrinseci
- Dissonnie
- Disturbi del sonno e della veglia
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie muscolari
- Malattie neuromuscolari
- Disturbi dell'inizio e del mantenimento del sonno
- Fibromialgia
- Sindromi Dolorose Miofasciali
Altri numeri di identificazione dello studio
- Pro00011861
- R01AR052368 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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