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Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

NCT ID: NCT00462150

Last Updated: 2007-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-06-30

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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home-based emotional disclosure

Intervention Type BEHAVIORAL

time management control condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Henriët van Middendorp, PhD

Role: PRINCIPAL_INVESTIGATOR

Utrecht University, Department of Clinical and Health Psychology

Rinie Geenen, PhD

Role: STUDY_CHAIR

Utrecht University, Department of Clinical and Health Psychology

Johannes WJ Bijlsma, PhD, MD

Role: STUDY_DIRECTOR

University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology

Locations

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Utrecht University, Department of Clinical and Health Psychology

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 17336025 (View on PubMed)

Other Identifiers

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NR 99-1-401

Identifier Type: -

Identifier Source: org_study_id