Pain and Stress Management for Fibromyalgia
15 mars 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
230
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Michigan
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Ann Arbor, Michigan, États-Unis, 48106
- University of Michigan Medical Center
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Detroit, Michigan, États-Unis, 48202
- Wayne State University
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Southfield, Michigan, États-Unis, 48075
- St. John Providence Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Brief Pain Inventory
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
SF-12
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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Patient Global Assessment of Change
Délai: 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
|
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Health Care Utilization Scale
Délai: 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
|
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Real-time Physical Activity (Actiwatch)
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Heart Rate Variability
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Levels of Emotional Awareness Scale
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Emotional Expressivity Scale
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Ambivalence over Emotional Expression
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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Toronto Alexithymia Scale-20
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
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
Délai: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
|
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mark A Lumley, Ph.D., Wayne State University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 juillet 2015
Achèvement de l'étude (Réel)
1 juillet 2015
Dates d'inscription aux études
Première soumission
2 novembre 2010
Première soumission répondant aux critères de contrôle qualité
28 janvier 2011
Première publication (Estimation)
1 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1R01AR057808 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .