- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00072657
Cognitive-Behavioral Therapy and Tai Chi Chih for Patients With Rheumatoid Arthritis
Behavioral Treatments for Rheumatoid Arthritis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Rheumatoid arthritis is a progressive inflammatory illness marked by severe functional declines, significant economic and social costs, and significant psychological distress. Environmental and psychosocial factors such as stress, mood disturbance, and coping mechanisms may contribute to changes in important health outcomes, including disability and disease activity in RA. This study will compare CBT with TCC, a relaxation-based intervention, combining elements of slow gentle movement with meditation, against a more traditional health education seminar. Outcome measures will include psychological adaptation, mood disturbance, sleep quality, physiological adaptation, and disease severity.
Two hundred-ten patients will be randomly assigned to either CBT, TCC, or a control group. The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations. Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each. Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher. TCC participants will have 50 to 60 minute biweekly sessions during the 12-week study. Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
Participants will be assessed prior to beginning treatment, at mid-treatment (Week 6) and again at the end of treatment (Week 12 to 13). The long term effect of interventions will be assessed at follow-up interviews 4 months and 8 months after the end of formal treatment. Psychosocial adaptation, mood disturbance and sleep quality, self-reported pain, and immune function will be measured at all five assessment periods.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095
- Cousins Center for Psychoneuroimmunology, UCLA
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Diagnosis of RA as defined by the American College of Rheumatology (ACR) and consistent with revised criteria for RA
- Stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
- Relatively stable disease course for 3 months prior to study entry
- If treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
- If taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
- Resides in Greater Los Angeles area
Exclusion Criteria:
- Inactive RA conditions defined as "in remission"
- Experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
- Serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
- Use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for RA treatment, tramadol (Ultram) or Tylenol with codeine on an as-needed basis, or propoxyphen (Darvocet, Wygesic)
- Use of oxycodone (Percocet), hydrocodone (Vicodin), morphine, or hydromorphone (Dilaudid)
- Use of high levels of methotrexate (greater than 7.5 mg)
- Use of nitrogen mustard, cyclosporine, monoclonal antibodies, or cyclophosphamide within the 6 months prior to study entry
- Serious psychiatric conditions, such as bipolar disorder, psychotic disorders, or organic brain syndromes
- At risk for suicide
- Dependent on canes, walkers, or other assistive devices
- Unable to commit to study schedule/itinerary or unwilling to be assigned to any of the 3 treatment groups
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Participants will partake in cognitive behavioral therapy for 12 weeks.
|
The CBT intervention will have three phases: 1) education on the nature of the adjustment process in chronic illness, 2) coping skill development, and 3) generalization and application of skills to everyday situations.
Participants in the CBT group will attend 12 weekly group sessions of about 2 hours each.
|
Experimental: 2
Participants will partake in tai chi chih for 12 weeks.
|
Participants in the TCC group will learn to perform 18 movements under the guidance of an expert TCC teacher.
TCC participants will have 50- to 60-minute biweekly sessions during the 12-week study.
|
Aktiver Komparator: 3
Participants will act as a control and attend educational sessions for 12 weeks.
|
Control group participants will attend weekly group educational sessions; these sessions will provide general knowledge about arthritis health and illness, and they will include lectures, demonstrations, and question-and-answer sessions with experts in rheumatology, sleep science, and behavioral medicine.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Disease activity
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Health functioning
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Inflammation, measured by levels of IL-1, IL-6, and tumor necrosis factor (TNF)-alpha
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Mood disturbances
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Coping
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Helplessness
Zeitfenster: Measured at Week 12 and Months 4 and 8 follow-up
|
Measured at Week 12 and Months 4 and 8 follow-up
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Perry M. Nicassio, PhD, University of California, Los Angeles
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01AR049840 (US NIH Stipendium/Vertrag)
- NIAMS-095
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 .
Klinische Studien zur Rheumatoide Arthritis
-
CEN BiotechMYEXPRESIONRekrutierungPolyarthritis; RheumatoidFrankreich
-
Centre Hospitalier Universitaire, AmiensUnbekanntMethotrexat | Polyarthritis; RheumatoidFrankreich
-
Chang Gung Memorial HospitalNoch keine RekrutierungArthritis-Knie | Arthritis HüfteTaiwan
-
Centocor, Inc.AbgeschlossenRheumatoide Arthritis, Jugendliche
-
Saint Alphonsus Regional Medical CenterAbgeschlossenArthritis-Knie | Arthritis der HüfteVereinigte Staaten
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoAbgeschlossen
-
Assistance Publique - Hôpitaux de ParisAbgeschlossenJuvenile idiopathische Arthritis | Arthritis, septisch | Arthritis, nicht näher bezeichnetFrankreich
-
University of Alabama at BirminghamNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) und andere MitarbeiterAbgeschlossen
-
AmgenBeendetJuvenile rheumatoide Arthritis
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)AbgeschlossenJuvenile rheumatoide ArthritisVereinigte Staaten
Klinische Studien zur Cognitive Behavioral Therapy
-
University of Social Sciences and Humanities, WarsawLondon School of Hygiene and Tropical Medicine; Institut National de la Santé... und andere MitarbeiterAbgeschlossen
-
University of ArizonaUnited States Department of Defense; Southern Arizona VA Health Care SystemAbgeschlossenDepression | Posttraumatische Belastungsstörung | SchlaflosigkeitVereinigte Staaten
-
Shanghai Mental Health CenterNoch keine RekrutierungErnährungs- und EssstörungenChina
-
Florida State UniversityAbgeschlossenAdhärenz, Behandlung | Zurückbehaltung | Kognitive Beeinträchtigung, leichtVereinigte Staaten
-
Florida State UniversityAbgeschlossenLeichte kognitive Einschränkung | Ketose | Adhärenz, PatientVereinigte Staaten
-
Linnaeus UniversityKarolinska Institutet; Capio Group; The Kamprad Family Foundation for Entrepreneurship...RekrutierungDepression | Zwangsstörung | Ausbrennen | Stress, Psychisch | Schlaflosigkeit | Generalisierte Angststörung | Psychische Belastung | Soziale Angststörung | Panikstörung | Anpassungsstörungen | Hypochondrie | Lebensstilbedingte Krankheit | LebensstressSchweden
-
University Rovira i VirgiliMinisterio de Economía y Competitividad, Spain; Obra Social de La CaixaAktiv, nicht rekrutierend
-
Milton S. Hershey Medical CenterRekrutierungADHSVereinigte Staaten
-
University of PennsylvaniaAbgeschlossenFettleibigkeitVereinigte Staaten
-
University of MichiganNational Institute of Mental Health (NIMH)AbgeschlossenSelbstmord | PsychoseVereinigte Staaten