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Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

Primary Purpose

Fatigue, Inflammatory Rheumatism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring fatigue, Inflammatory Rheumatism, Coping, self-efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients with inflammatory rheumatic diseases

    Arm Description

    The patients will participate in a cognitive behavioural therapy intervention

    Outcomes

    Primary Outcome Measures

    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
    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)
    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.
    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)
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2017
    Last Updated
    July 11, 2017
    Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Extrastiftelsen, Norsk revmatikerforbund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03216616
    Brief Title
    Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
    Official Title
    Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Extrastiftelsen, Norsk revmatikerforbund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, Inflammatory Rheumatism
    Keywords
    fatigue, Inflammatory Rheumatism, Coping, self-efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with inflammatory rheumatic diseases
    Arm Type
    Experimental
    Arm Description
    The patients will participate in a cognitive behavioural therapy intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioural Therapy
    Primary Outcome Measure Information:
    Title
    Screening of the perceived level of fatigue in patients with inflammatory rheumatic disease
    Description
    Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Chalder Fatigue Questionnaire
    Time Frame
    2-10 minutes
    Title
    Screening of depressive symptoms in patients with inflammatory rheumatic disease and fatigue
    Description
    Patients with rheumatic inflammatory diseases suffering from fatigue will be asked to complete the Patient Health Questionnaire-9 (PHQ-9)
    Time Frame
    2-10 minutes
    Title
    Screening of the patients perceived self efficacy in coping with fatigue
    Description
    The patients will be asked to answer questions about fatigue, activity and rest, sleep problems, worrying and rumination.
    Time Frame
    10-15 minutes
    Title
    Reduce perceived fatigue and increase perceived self efficacy in relation to coping with fatigue in patients with inflammatory rheumatic diseases
    Description
    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)
    Time Frame
    6 weeks-6 months
    Title
    Detection of changes in perceived levels of fatigue
    Description
    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.
    Time Frame
    2-10 minutes
    Title
    Detection of changes in symptoms of depression
    Description
    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.
    Time Frame
    2-10 minutes
    Title
    Detection of changes in the patients perceived self efficacy in coping with fatigue
    Description
    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.
    Time Frame
    10-15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

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