Clinical trial NCT00462150: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: arthritis, rheumatoid
expressed emotion
randomized controlled trial
affect
blood sedimentation
psychophysiology
feasibility studies
intervention studies
time management
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressed mood.
measure: Cheerful mood.
measure: Both measures at baseline, 1 week after intervention, and 3 months after intervention.
Secondary outcomes:
measure: Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the intervention).
measure: Induction of core elements: immediate negative affect change, emotion, insight, and optimism word use during the intervention.
measure: Clinical measures: Joint score; Erythrocyte Sedimentation Rate; both measures at baseline, 1 week after intervention, and 3 months after intervention.
measure: 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.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University, Department of Clinical and Health Psychology
Study officials:
affiliation: Utrecht University, Department of Clinical and Health Psychology
name: Henriët van Middendorp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utrecht University, Department of Clinical and Health Psychology
name: Rinie Geenen, PhD
role: STUDY_CHAIR
affiliation: University Medical Center Utrecht, Department of Rheumatology & Clinical Immunology
name: Johannes WJ Bijlsma, PhD, MD
role: STUDY_DIRECTOR
References:
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.