NCT03216616

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

July 5, 2017

Last Update Submit

July 11, 2017

Conditions

FatigueInflammatory Rheumatism

Keywords

fatigueInflammatory RheumatismCopingself-efficacy

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Patients with inflammatory rheumatic diseases

EXPERIMENTAL

The patients will participate in a cognitive behavioural therapy intervention

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural TherapyBEHAVIORAL
Patients with inflammatory rheumatic diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 18 years with inflammatory rheumatic diseases and fatigue at Department of Rheumatology, Diakonhjemmet Hospital

You may not qualify if:

  • Unable to provide informed consent
  • Unable to read and understand Norwegian
  • Unable to complete a survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueRheumatic Fever

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 13, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share