Pain and Stress Management for Fibromyalgia
15. mars 2016 oppdatert av: Mark A. Lumley, Wayne State University
Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia
This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition.
The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
230
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- University of Michigan Medical Center
-
Detroit, Michigan, Forente stater, 48202
- Wayne State University
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Southfield, Michigan, Forente stater, 48075
- St. John Providence Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:
- 1990 ACR criteria including tender points
- 2010 ACR modified clinical criteria that does not include tender points
Exclusion Criteria:
- Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
- Other serious medical conditions that can impair health status independent of FM
- Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
- Alcohol/drug dependence in past 2 years
- Cognitive impairment or dementia
- Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
- Unable to fluently read or converse in English
- Planning to move from the area in the next 14 months
- Judgment of principle investigator as not appropriate for this trial or all intervention arms
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties.
It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
|
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
|
|
Aktiv komparator: Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia.
It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
|
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
|
|
Aktiv komparator: Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health.
It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
|
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Brief Pain Inventory
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
SF-12
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
PROMIS Fatigue short form
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Pittsburgh Sleep Quality Index
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Center for Epidemiological Studies - Depression Scale
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Generalized Anxiety Disorder - 7
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Positive and Negative Affect Schedule
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Satisfaction with Life Scale
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Multiple Ability Self-Report Questionnaire
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Patient Global Assessment of Change
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Health Care Utilization Scale
Tidsramme: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
|
Real-time Physical Activity (Actiwatch)
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Heart Rate Variability
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Levels of Emotional Awareness Scale
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Emotional Expressivity Scale
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Ambivalence over Emotional Expression
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Toronto Alexithymia Scale-20
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Impact of Events Scale - Revised
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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BBCA - short form
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Pain Catastrophizing
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Beliefs in Pain Control Questionnaire
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
Communication Thoughts and Feelings Questionnaire
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Experimental (thumb nail pressure) threshold and tolerance ratings
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
|
2010 ACR modified clinical criteria for FM, including widespread pain index
Tidsramme: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mark A Lumley, Ph.D., Wayne State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2011
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
2. november 2010
Først innsendt som oppfylte QC-kriteriene
28. januar 2011
Først lagt ut (Anslag)
1. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R01AR057808 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .