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OpenTrials
Completed

NCT Number: NCT03216616

Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Primary outcomes

  1. 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. 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)

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Extrastiftelsen
  • Norsk revmatikerforbund

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2017
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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