Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

July 11, 2017 updated by: Elin Fjerstad, Diakonhjemmet Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening of the perceived level of fatigue in patients with inflammatory rheumatic disease
Time Frame: 2-10 minutes
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
Time Frame: 2-10 minutes
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
Time Frame: 10-15 minutes
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
Time Frame: 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)
6 weeks-6 months
Detection of changes in perceived levels of fatigue
Time Frame: 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.
2-10 minutes
Detection of changes in symptoms of depression
Time Frame: 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.
2-10 minutes
Detection of changes in the patients perceived self efficacy in coping with fatigue
Time Frame: 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.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonhjemmet Hospital

Collaborators

Extrastiftelsen
Norsk revmatikerforbund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/395 (REK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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