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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03216616
Other study ID # 2014/395 (REK)
Secondary ID
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
Health authority
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

Study Design


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
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