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Sleep and Pain Interventions in Fibromyalgia (SPIN)

27 november 2013 bijgewerkt door: University of Florida

Sleep and Pain Interventions in Fibromyalgia: Hyperalgesia and Central Sensitization

This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

113

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32610
        • University of Florida

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Cognitieve gedragstherapie voor slapeloosheid (CBT-I)
Actieve vergelijker: 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.
Gedragsmatig: Cognitive Behavioral Therapy for Pain (CBT-P)
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in time spent awake during the night.
Tijdsspanne: 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.
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in self-report of pain experience.
Tijdsspanne: 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.
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Florida

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Christina S McCrae, PhD, University of Florida

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2009

Primaire voltooiing (Werkelijk)

1 september 2013

Studie voltooiing (Werkelijk)

1 september 2013

Studieregistratiedata

Eerst ingediend

27 november 2013

Eerst ingediend dat voldeed aan de QC-criteria

27 november 2013

Eerst geplaatst (Schatting)

4 december 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

4 december 2013

Laatste update ingediend die voldeed aan QC-criteria

27 november 2013

Laatst geverifieerd

1 november 2013

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 627-2007
  • R01AR055160 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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