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Completed

NCT Number: NCT01765725

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

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Coping Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irma Pinxsterhuis

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

patient education program

Behavioral

Patient education program, 8 meetings, every other week, 2,5 hours per meeting.

Primary outcomes

  1. SF-36, subscale Physical functioning.

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in physical functioning.

  2. Illness Management Questionnaire (IMQ).

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in ways of coping with CFS.

Secondary outcomes

  1. The SF-36 (total score and subscale role limitations due to physical limitations).

    Time frame: 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.

  2. Fatigue Severity Scale (FSS).

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in fatigue-related severity, symptomatology, and functional disability.

  3. Illness Cognition Questionnaire (ICQ)

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measure change in helplessness, acceptance, and perceived benefits.

  4. The Fennell Phase Inventory (FPI)

    Time frame: 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.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in anxiety and depression.

  6. Perceived Stress Scale (PSS)- 10 items

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in global perceived stress.

  7. Brief Illness Perception Questionnaire (BIPQ)

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in cognitive and emotional representations of illness.

  8. Self-efficacy Scale (SE24)

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in perceived control with respect to CFS complains.

  9. Self-defined fatigue and pain scale

    Time frame: T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months.

    Measures change in perceived fatigue and pain.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Stiftelsen Helse og Rehabilitering

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2013
Registry last updated
Oct 16, 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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