Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00462150
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-09
• Study Completion: 2003-06
• Status Verified: 2007-04
• Study First Submitted: 2007-04-16
• Study First Submitted QC: 2007-04-16
• Last Update Submitted: 2007-04-16
• Study First Posted: 2007-04-18
• Last Update Posted: 2007-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressed mood.
Cheerful mood.
Both measures at baseline, 1 week after intervention, and 3 months after intervention.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Utrecht University, Department of Clinical and Health Psychology; 🇳🇱 Utrecht, Netherlands