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Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00462150
First received: April 16, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Behavioral: home-based emotional disclosure
Behavioral: time management control condition
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Depressed mood.
  • Cheerful mood.
  • Both measures at baseline, 1 week after intervention, and 3 months after intervention.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 80
Study Start Date: September 2002
Study Completion Date: June 2003
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462150

Locations
Netherlands
Utrecht University, Department of Clinical and Health Psychology
Utrecht, Netherlands, PO Box 80.140, 3508 TC
Sponsors and Collaborators
UMC Utrecht
Investigators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00462150     History of Changes
Other Study ID Numbers: NR 99-1-401
Study First Received: April 16, 2007
Last Updated: April 16, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
arthritis, rheumatoid
expressed emotion
randomized controlled trial
affect
blood sedimentation
 psychophysiology
feasibility studies
intervention studies
time management

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013