| April 16, 2007 |
| April 16, 2007 |
| September 2002 |
| |
- Depressed mood.
- Cheerful mood.
- Both measures at baseline, 1 week after intervention, and 3 months after intervention.
|
| Same as current |
| No Changes Posted |
- 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.
|
| Same as current |
| |
| Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis |
| Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA) |
The purpose of the study is threefold: 1) to develop a home-based emotional disclosure intervention inducing core elements of change (emotional engagement, cognitive restructuring, and positive future directedness); 2) to examine in a randomized controlled trial in patients with rheumatoid arthritis the induction of the core elements and the feasibility of the intervention for home application; and, 3) to examine the psychological, clinical, and physiological effects of the adapted emotional disclosure intervention and the modulating role of cognitive-emotional change and individual differences in emotion regulation. |
Emotional disclosure has been suggested to alleviate psychological and physical stress in chronically ill people. Emotional engagement, cognitive restructuring, and positive future directedness are considered core elements to induce change in emotional disclosure interventions. The aim of our randomized controlled trial in patients with rheumatoid arthritis is to examine the psychological, clinical, and physiological effects of an emotional disclosure intervention adapted for home application and the modulating role of cognitive-emotional change and individual differences in emotion regulation. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Rheumatoid Arthritis |
- Behavioral: home-based emotional disclosure
- Behavioral: time management control condition
|
| |
| van Middendorp H, Sorbi MJ, van Doornen LJ, Bijlsma JW, Geenen R. Feasibility and induced cognitive-emotional change of an emotional disclosure intervention adapted for home application. Patient Educ Couns. 2007 Feb 28; [Epub ahead of print] |
| |
| Completed |
| 80 |
| June 2003 |
|
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis according to the criteria of the American College of Rheumatology (Arthritis Rheum 1988;31:315-24
- Written informed consent
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Netherlands |
| |
| NCT00462150 |
|
| NR 99-1-401 |
| UMC Utrecht |
|
| 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 |
|
|
| UMC Utrecht |
| April 2007 |
