Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
Information source: UMC Utrecht
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: home-based emotional disclosure (Behavioral); time management control condition (Behavioral)
Phase: Phase 2
Status: Completed
Sponsored by: UMC Utrecht Official(s) and/or principal investigator(s):
Henriët van Middendorp, PhD, Principal Investigator, Affiliation: Utrecht University, Department of Clinical and Health Psychology
Rinie Geenen, PhD, Study Chair, Affiliation: Utrecht University, Department of Clinical and Health Psychology
Johannes WJ Bijlsma, PhD, MD, Study Director, Affiliation: University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology
Summary
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.
Clinical Details
Official title: Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Depressed mood.Cheerful mood. Both measures at baseline, 1 week after intervention, and 3 months after intervention.
Secondary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Utrecht University, Department of Clinical and Health Psychology, Utrecht PO Box 80.140, 3508 TC, Netherlands
Additional Information
Starting date: September 2002
Ending date: June 2003
Last updated: April 16, 2007
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