Back to resultsEffects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
home-based emotional disclosure
time management control condition
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring arthritis, rheumatoid, expressed emotion, randomized controlled trial, affect, blood sedimentation, psychophysiology, feasibility studies, intervention studies, time management
Eligibility 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
Sites / Locations
- Utrecht University, Department of Clinical and Health Psychology
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00462150
Brief Title
Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
Official Title
Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
arthritis, rheumatoid, expressed emotion, randomized controlled trial, affect, blood sedimentation, psychophysiology, feasibility studies, intervention studies, time management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
home-based emotional disclosure
Intervention Type
Behavioral
Intervention Name(s)
time management control condition
Primary Outcome Measure Information:
Title
Depressed mood.
Title
Cheerful mood.
Title
Both measures at baseline, 1 week after intervention, and 3 months after intervention.
Secondary Outcome Measure Information:
Title
Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).
Title
Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.
Title
Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henriët van Middendorp, PhD
Organizational Affiliation
Utrecht University, Department of Clinical and Health Psychology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rinie Geenen, PhD
Organizational Affiliation
Utrecht University, Department of Clinical and Health Psychology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johannes WJ Bijlsma, PhD, MD
Organizational Affiliation
University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology
Official's Role
Study Director
Facility Information:
Facility Name
Utrecht University, Department of Clinical and Health Psychology
City
Utrecht
ZIP/Postal Code
PO Box 80.140, 3508 TC
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
17336025
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis
We'll reach out to this number within 24 hrs