Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Not Applicable

Completed

• Conditions: Inflammatory Rheumatism; Fatigue
• Interventions: Behavioral: Cognitive Behavioural Therapy

• Registration Number: NCT03216616
• Lead Sponsor: Diakonhjemmet Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-11
• Last Update Submitted: 2017-07-11
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with inflammatory rheumatic diseases	Cognitive Behavioural Therapy	The patients will participate in a cognitive behavioural therapy intervention

Primary Outcome Measures

Name	Time	Method
Detection of changes in the patients perceived self efficacy in coping with fatigue	10-15 minutes	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.
Reduce perceived fatigue and increase perceived self efficacy in relation to coping with fatigue in patients with inflammatory rheumatic diseases	6 weeks-6 months	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)
Screening of the perceived level of fatigue in patients with inflammatory rheumatic disease	2-10 minutes	Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Chalder Fatigue Questionnaire
Screening of depressive symptoms in patients with inflammatory rheumatic disease and fatigue	2-10 minutes	Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Patient Health Questionnaire-9 (PHQ-9)
Screening of the patients perceived self efficacy in coping with fatigue	10-15 minutes	The patients will be asked to answer questions about fatigue, activity and rest, sleep problems, worrying and rumination.
Detection of changes in symptoms of depression	2-10 minutes	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.
Detection of changes in perceived levels of fatigue	2-10 minutes	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.