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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Fatigue Syndrome, Coping, Patient Education

Intervention / Treatment
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* Behavioral: Patient education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations | |
| Experimental: Patient education program<br>Patient education program | Behavioral: Patient education program<br>* Patient education program, 8 meetings, every other week, 2,5 hours per meeting.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Fatigue Syndrome, Coping, Patient education