Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis - Full Text View

Sponsor:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00462150

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

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:

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]

Study ID Numbers:	NR 99-1-401
Study First Received:	April 16, 2007
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00462150 History of Changes
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:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010