Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Study Overview
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Brief Summary
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Fatigue is common and debilitating in rheumatic inflammatory diseases as for other chronical medical conditions. The purpose of this study is to develope and evaluate a cognitive behavioural intervention targeting fatigue. The aim of the intervention is to improve fatigue self-management by changing behavioral and cognitive factors contributing to perceived fatigue. Levels of fatigue, depressive symptoms and self esteem will be measured before, after and three months after the intervention.

Official Title
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Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Conditions
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Fatigue, Inflammatory Rheumatism

Intervention / Treatment
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* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Men and women over 18 years with inflammatory rheumatic diseases and fatigue at Department of Rheumatology, Diakonhjemmet Hospital Exclusion Criteria: Unable to provide informed consent Unable to read and understand Norwegian Unable to complete a survey

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with inflammatory rheumatic diseases<br>The patients will participate in a cognitive behavioural therapy intervention | Behavioral: Cognitive Behavioural Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening of the perceived level of fatigue in patients with inflammatory rheumatic disease | Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Chalder Fatigue Questionnaire | 2-10 minutes | 
| Screening of depressive symptoms in patients with inflammatory rheumatic disease and fatigue | Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Patient Health Questionnaire-9 (PHQ-9) | 2-10 minutes | 
| Screening of the patients perceived self efficacy in coping with fatigue | The patients will be asked to answer questions about fatigue, activity and rest, sleep problems, worrying and rumination. | 10-15 minutes | 
| Reduce perceived fatigue and increase perceived self efficacy in relation to coping with fatigue in patients with inflammatory rheumatic diseases | Patients enrolled in the study will attend a course or an individual treatment with a clinical psychologist aimed to reduce symptoms of fatigue and improve their self efficacy by means of Cognitive Behaviour Therapy (CBT) | 6 weeks-6 months | 
| Detection of changes in perceived levels of fatigue | Patients will be asked to complete the Chalder Fatigue Questionnaire one month and three months after receiving CBT. Results will be compared to the scores obtained prior to CBT. | 2-10 minutes | 
| Detection of changes in symptoms of depression | The patients will be asked to complete the Patient Health Questionnaire-9 (PHQ-9) one month and three months after receiving CBT. Results will be compared to the scores obtained prior to CBT. | 2-10 minutes | 
| Detection of changes in the patients perceived self efficacy in coping with fatigue | The patients will be asked to answer questions about fatigue, activity and rest, sleep problems, worrying and rumination one month and three months after receiving CBT. Results will be compared to the scores obtained prior to CBT. | 10-15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, Inflammatory Rheumatism, Coping, self-efficacy