Sleep and Pain Interventions in Fibromyalgia (SPIN)
Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Participants will be asked to review the informed consent and consent to the study prior to any study procedure.
There are six phases of this study: 1. a telephone interview, 2. an in-home single night sleep recording, 3. a two-week baseline period, 4. an 8-week treatment period, 5. a two-week follow-up period, and 6. another two week follow-up period 6-months after the treatment period.
During the telephone interview, participants will be asked question about their sleep and pain history. Participants with poor sleep will visit the University of Florida for a medical history and will be connected to a machine which will monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. A third visit will consist of completing questionnaires and measuring response to a range of temperatures. Participants will complete brief daily questionnaires and wear an actigraph (wristwatch-like device) that measures arm movements for two weeks.
Participants will then be randomized to one of three groups: a pain treatment group, an insomnia treatment group or a waitlist control group. Both treatments consist of weekly therapy sessions for 8 consecutive weeks. Participants assigned to waitlist control will be offered therapy at no cost at the end of the study. Throughout these 8 weeks, participants in all three groups will be asked to complete daily sleep diaries.
The study consists of two follow-up periods consisting of two weeks, during which participants will wear the actigraph and complete daily sleep diaries. Participants will travel to the University two times during each follow-up period. One follow-up period will occur immediately following treatment, and the other will occur approximately 6 months following treatment. During each follow-up period, the first visits will involve being connected to the machine that monitors their sleep. Participants will then return home with the machine to sleep in their own beds. The second of these visits will occur the following day and will involve the return of the machine, completion of questionnaires, and measurement of participants' responses to a range of temperatures applied to their arm.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Florida
-
Gainesville, Florida, Stati Uniti, 32610
- University of Florida
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of fibromyalgia
- Diagnosis of insomnia
- No sleep medications for at least 1 month, or stable on medications for at least 6 months
- Willing to be randomly assigned to a treatment
- Able to read and understand English
Exclusion Criteria:
- Sleep disorder other than insomnia
- Bipolar disorder
- Seizure disorder
- Severe untreated psychopathology
- Cognitive impairment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: CBT-I
Participants will complete 8 weekly therapy sessions focused on improving sleep.
A multicomponent CBT-I (Cognitive Behavioral Therapy for Insomnia) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive restructuring.
|
|
|
Comparatore attivo: CBT-P
Participants will complete 8 weekly therapy sessions focused on improving pain.
A multicomponent CBT-P (Cognitive Behavioral Therapy for Pain) protocol will involve: pain education, relaxation, activity pacing, and cognitive restructuring.
|
|
|
Nessun intervento: Waitlist Control (WLC)
Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments.
After the final follow-up assessment, they will be offered the opportunity to receive therapy which combines aspects of both CBT-I and CBT-P.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in time spent awake during the night.
Lasso di tempo: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
|
The change in the time participants report spending awake during the night.
Sleep will be measured with daily diaries and, means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.
|
Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
|
|
Change in mood.
Lasso di tempo: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.
|
Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in self-report of pain experience.
Lasso di tempo: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
The change in participants' report of their pain experience from baseline to the two follow-up periods.
Pain will be assessed by daily diaries, and means of the 14 days collected at baseline, immediately, and 6 months following treatment will be calculated.
|
Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
|
|
Change in mood.
Lasso di tempo: Change from baseline to the two follow-up periods (immediately and 3-months following treatment).
|
The change in reported mood as assessed by questionnaires from baseline to immediately and 6 months following treatment.
|
Change from baseline to the two follow-up periods (immediately and 3-months following treatment).
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christina S McCrae, PhD, University of Florida
Pubblicazioni e link utili
Pubblicazioni generali
- Anderson RJ, McCrae CS, Staud R, Berry RB, Robinson ME. Predictors of clinical pain in fibromyalgia: examining the role of sleep. J Pain. 2012 Apr;13(4):350-8. doi: 10.1016/j.jpain.2011.12.009. Epub 2012 Mar 3.
- McCrae CS, Craggs JG, Curtis AF, Nair N, Kay D, Staud R, Berry RB, Robinson ME. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. J Clin Sleep Med. 2022 Jan 1;18(1):203-215. doi: 10.5664/jcsm.9540.
- Miller MB, Curtis AF, Chan WS, Deroche CB, McCrae CS. Daily associations between sleep and opioid use among adults with comorbid symptoms of insomnia and fibromyalgia. J Clin Sleep Med. 2021 Apr 1;17(4):729-737. doi: 10.5664/jcsm.9002.
- McCrae CS, Curtis AF, Miller MB, Nair N, Rathinakumar H, Davenport M, Berry JR, McGovney K, Staud R, Berry R, Robinson M. Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. J Sleep Res. 2020 Dec;29(6):e13020. doi: 10.1111/jsr.13020. Epub 2020 Mar 3.
- Curtis AF, Miller MB, Rathinakumar H, Robinson M, Staud R, Berry RB, McCrae CS. Opioid use, pain intensity, age, and sleep architecture in patients with fibromyalgia and insomnia. Pain. 2019 Sep;160(9):2086-2092. doi: 10.1097/j.pain.0000000000001600.
- McCrae CS, Williams J, Roditi D, Anderson R, Mundt JM, Miller MB, Curtis AF, Waxenberg LB, Staud R, Berry RB, Robinson ME. Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. Sleep. 2019 Mar 1;42(3):zsy234. doi: 10.1093/sleep/zsy234.
- Miller MB, Chan WS, Curtis AF, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Pain intensity as a moderator of the association between opioid use and insomnia symptoms among adults with chronic pain. Sleep Med. 2018 Dec;52:98-102. doi: 10.1016/j.sleep.2018.08.015. Epub 2018 Sep 5.
- McCrae CS, Mundt JM, Curtis AF, Craggs JG, O'Shea AM, Staud R, Berry RB, Perlstein WM, Robinson ME. Gray Matter Changes Following Cognitive Behavioral Therapy for Patients With Comorbid Fibromyalgia and Insomnia: A Pilot Study. J Clin Sleep Med. 2018 Sep 15;14(9):1595-1603. doi: 10.5664/jcsm.7344.
- Curtis AF, Miller MB, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Discrepancies in sleep diary and actigraphy assessments in adults with fibromyalgia: Associations with opioid dose and age. J Sleep Res. 2019 Oct;28(5):e12746. doi: 10.1111/jsr.12746. Epub 2018 Jul 31.
- Miller MB, Chan WS, Boissoneault J, Robinson M, Staud R, Berry RB, McCrae CS. Dynamic daily associations between insomnia symptoms and alcohol use in adults with chronic pain. J Sleep Res. 2018 Jun;27(3):e12604. doi: 10.1111/jsr.12604. Epub 2017 Sep 22.
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 627-2007
- R01AR055160 (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 .
Prove cliniche su Terapia cognitivo comportamentale per l'insonnia (CBT-I)
-
Ontario Shores Centre for Mental Health SciencesMindbeaconRitiratoDisturbo depressivo maggiore
-
Hackensack Meridian HealthNew Jersey Health FoundationReclutamentoDepressione postpartoStati Uniti