Rheumatoid Arthritis
Conditions
Keywords
arthritis, rheumatoid, expressed emotion, randomized controlled trial, affect, blood sedimentation, psychophysiology, feasibility studies, intervention studies, time management
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.
Interventions
BEHAVIORALhome-based emotional disclosure
BEHAVIORALtime management control condition
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressed mood. | — |
| Cheerful mood. | — |
| Both measures at baseline, 1 week after intervention, and 3 months after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility: adherence, compliance with instructions, perceived viability, clinical safety; all measured during or immediately after the 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. | — |
| 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. | — |
Countries
Netherlands
Outcome results
None listed