- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01287481
Pain and Stress Management for Fibromyalgia
15. März 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
230
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48106
- University of Michigan Medical Center
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Detroit, Michigan, Vereinigte Staaten, 48202
- Wayne State University
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Southfield, Michigan, Vereinigte Staaten, 48075
- St. John Providence Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Aktiver 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.
|
Aktiver 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Brief Pain Inventory
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
SF-12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Satisfaction with Life Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Heart Rate Variability
Zeitfenster: 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
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Emotional Expressivity Scale
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Ambivalence over Emotional Expression
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Toronto Alexithymia Scale-20
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Pain Catastrophizing
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Experimental (thumb nail pressure) threshold and tolerance ratings
Zeitfenster: 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
Zeitfenster: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mark A Lumley, Ph.D., Wayne State University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2011
Primärer Abschluss (Tatsächlich)
1. Juli 2015
Studienabschluss (Tatsächlich)
1. Juli 2015
Studienanmeldedaten
Zuerst eingereicht
2. November 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Januar 2011
Zuerst gepostet (Schätzen)
1. Februar 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. März 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. März 2016
Zuletzt verifiziert
1. März 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1R01AR057808 (US NIH Stipendium/Vertrag)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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