Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

Study Overview
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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.

Official Title
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Psychological, Physiological, and Clinical Consequences of Emotional Disclosure in Rheumatoid Arthritis (RA)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: home-based emotional disclosure
* Behavioral: time management control condition


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: home-based emotional disclosure|nan|
|Behavioral: time management control condition|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressed mood. |  |  | 
| Cheerful mood. |  |  | 
| Both measures at baseline, 1 week after intervention, and 3 months after intervention. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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affect, arthritis, rheumatoid, expressed emotion, randomized controlled trial, blood sedimentation, psychophysiology, feasibility studies, intervention studies, time management