Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

NCT00462150 | Completed Phase 2

• 1 other identifier: NR 99-1-401
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

arthritis, rheumatoid; expressed emotion; randomized controlled trial; affect; blood sedimentation; psychophysiology; feasibility studies; intervention studies; time management

Outcome Measures

Primary Outcomes (3)

• Depressed mood.

• Cheerful mood.

• Both measures at baseline, 1 week after intervention, and 3 months after intervention.

Secondary Outcomes (4)

• 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.

Interventions

home-based emotional disclosure BEHAVIORAL

time management control condition BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rheumatoid arthritis according to the criteria of the American College of Rheumatology (Arthritis Rheum 1988;31:315-24
• Written informed consent

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

Utrecht University, Department of Clinical and Health Psychology

Utrecht, Utrecht, PO Box 80.140, 3508 TC, Netherlands

Location

Related 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. doi: 10.1016/j.pec.2006.11.009. Epub 2007 Mar 1.

  PMID: 17336025 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Henriët van Middendorp, PhD

  Utrecht University, Department of Clinical and Health Psychology

  PRINCIPAL INVESTIGATOR

• Rinie Geenen, PhD

  Utrecht University, Department of Clinical and Health Psychology

  STUDY CHAIR

• Johannes WJ Bijlsma, PhD, MD

  University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: September 1, 2002
• Study Completion: June 1, 2003
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

NL (1)