Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT00462150|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Behavioral: home-based emotional disclosure Behavioral: time management control condition||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)|
|Study Start Date :||September 2002|
|Actual Study Completion Date :||June 2003|
- Depressed mood.
- Cheerful mood.
- Both measures at baseline, 1 week after intervention, and 3 months after intervention.
- Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).
- Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.
- Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.
- Physiological measures: 24-h Urinary cortisol; 24-h Urinary noradrenaline; IL-6; IFN-γ; IL-10; all measures at baseline, 1 week after intervention, and 3 months after intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462150
|Utrecht University, Department of Clinical and Health Psychology|
|Utrecht, Netherlands, PO Box 80.140, 3508 TC|
|Principal Investigator:||Henriët van Middendorp, PhD||Utrecht University, Department of Clinical and Health Psychology|
|Study Chair:||Rinie Geenen, PhD||Utrecht University, Department of Clinical and Health Psychology|
|Study Director:||Johannes WJ Bijlsma, PhD, MD||University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology|