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Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00462150
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : April 18, 2007
Sponsor:
Information provided by:
UMC Utrecht

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

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U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).
  2. Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.
  3. Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.
  4. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00462150     History of Changes
Other Study ID Numbers: NR 99-1-401
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

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