Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Fatigue Clinical Trial

Official title:

Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216616
• Other study ID #: 2014/395 (REK)
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: July 11, 2017
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Fatigue
• Inflammatory Rheumatism
• Rheumatic Diseases
• Rheumatic Fever

Intervention

Behavioral:
• Cognitive Behavioural Therapy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Extrastiftelsen, Norsk revmatikerforbund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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