Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462150
• Other study ID #: NR 99-1-401
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2007
• Last updated: April 16, 2007
• Start date: September 2002
• Est. completion date: June 2003

Study information

• Verified date: April 2007
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• home-based emotional disclosure

• time management control condition

Locations

Country	Name	City	State
Netherlands	Utrecht University, Department of Clinical and Health Psychology	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 May;66(2):177-87. Epub 2007 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressed mood.
Primary	Cheerful mood.
Primary	Both measures at baseline, 1 week after intervention, and 3 months after intervention.
Secondary	Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).
Secondary	Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.
Secondary	Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.
Secondary	Physiological measures: 24-h Urinary cortisol; 24-h Urinary noradrenaline; IL-6; IFN-?; IL-10; all measures at baseline, 1 week after intervention, and 3 months after intervention.