Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program

Not Applicable

Completed

• Conditions: Coping; Patient Education; Chronic Fatigue Syndrome
• Interventions: Behavioral: Patient education program

• Registration Number: NCT01765725
• Lead Sponsor: Oslo University Hospital

Brief Summary

The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare.

In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual.

The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.

Detailed Description

The project is a single blind randomized controlled trial. A total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. The 75 participants in the intervention group will be allocated to 6 groups. The control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 18 years and older
• Meets Fukuda's research diagnostic criteria and Canadian CFS case definition
• Has given oral and written informed consent
• Able to tak part in the program that lasts 2,5 hours in addition to transport to and from the location for intervention.

Exclusion Criteria

• Psychosis or other severe psychiatric diseases, severe personality disturbances and/or substance dependency
• Pregnancy
• Not being able to understand, speak and read Norwegian
• Not willing to accept random assignment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient education program	Patient education program	Patient education program

Primary Outcome Measures

Name	Time	Method
SF-36, subscale Physical functioning.	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in physical functioning.
Illness Management Questionnaire (IMQ).	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in ways of coping with CFS.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy Scale (SE24)	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in perceived control with respect to CFS complains.
Hospital Anxiety and Depression Scale (HADS)	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in anxiety and depression.
Brief Illness Perception Questionnaire (BIPQ)	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in cognitive and emotional representations of illness.
Illness Cognition Questionnaire (ICQ)	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measure change in helplessness, acceptance, and perceived benefits.
Perceived Stress Scale (PSS)- 10 items	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in global perceived stress.
Fatigue Severity Scale (FSS).	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in fatigue-related severity, symptomatology, and functional disability.
The SF-36 (total score and subscale role limitations due to physical limitations).	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	The SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations.
The Fennell Phase Inventory (FPI)	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase.
Self-defined fatigue and pain scale	T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.	Measures change in perceived fatigue and pain.

Trial Locations

Locations (1)

Irma Pinxsterhuis; 🇳🇴 Oslo, Norway