Pain and Stress Management for Fibromyalgia
15 maart 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
230
Fase
- Fase 2
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
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48106
- University of Michigan Medical Center
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Detroit, Michigan, Verenigde Staten, 48202
- Wayne State University
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Southfield, Michigan, Verenigde Staten, 48075
- St. John Providence Hospital
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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 tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
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: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
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Actieve vergelijker: 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.
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Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
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Actieve vergelijker: 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.
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Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Brief Pain Inventory
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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SF-12
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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PROMIS Fatigue short form
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
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Pittsburgh Sleep Quality Index
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Center for Epidemiological Studies - Depression Scale
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Generalized Anxiety Disorder - 7
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Positive and Negative Affect Schedule
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Satisfaction with Life Scale
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
|
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Multiple Ability Self-Report Questionnaire
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Patient Global Assessment of Change
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Health Care Utilization Scale
Tijdsspanne: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
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Real-time Physical Activity (Actiwatch)
Tijdsspanne: 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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Heart Rate Variability
Tijdsspanne: 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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Levels of Emotional Awareness Scale
Tijdsspanne: 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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Emotional Expressivity Scale
Tijdsspanne: 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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Ambivalence over Emotional Expression
Tijdsspanne: 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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Toronto Alexithymia Scale-20
Tijdsspanne: 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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Impact of Events Scale - Revised
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Beliefs in Pain Control Questionnaire
Tijdsspanne: 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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Communication Thoughts and Feelings Questionnaire
Tijdsspanne: 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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Experimental (thumb nail pressure) threshold and tolerance ratings
Tijdsspanne: 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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2010 ACR modified clinical criteria for FM, including widespread pain index
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark A Lumley, Ph.D., Wayne State University
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 mei 2011
Primaire voltooiing (Werkelijk)
1 juli 2015
Studie voltooiing (Werkelijk)
1 juli 2015
Studieregistratiedata
Eerst ingediend
2 november 2010
Eerst ingediend dat voldeed aan de QC-criteria
28 januari 2011
Eerst geplaatst (Schatting)
1 februari 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
17 maart 2016
Laatste update ingediend die voldeed aan QC-criteria
15 maart 2016
Laatst geverifieerd
1 maart 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R01AR057808 (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 .