Chronic Fatigue Syndrome, Coping, Patient Education
Conditions
Keywords
Chronic Fatigue Syndrome, Coping, Patient education
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.
Interventions
BEHAVIORALPatient education program
Patient education program, 8 meetings, every other week, 2,5 hours per meeting.
Sponsors
Stiftelsen Helse og Rehabilitering
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Norway
Outcome results
None listed