The effect of self-instructions in the treatment of patients with Chronic Fatigue Syndrome type Idiopathic Chronic Fatigue (CFS-ICF) : a randomised controlled study.

The effect of self-instructions in the treatment of patients with Chronic Fatigue Syndrome type Idiopathic Chronic Fatigue (CFS-ICF): a randomised controlled study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28402

Enrollment

100

Registered

2009-02-05

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Chronic Fatigue Syndrome (CFS)

Interventions

After a baseline assessment (T1) patients are randomly assigned to the intervention- or waiting list condition. The patients in the intervention condition start immediately with the minimal interventi

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years or older; 2. Able to speak, read and write Dutch language; 3. CIS fatigue score of 35 or higher; 4. Sickness Impact Profile between 450 and 700 and/or 3 or less CDC symptoms.

Exclusion criteria

Exclusion criteria: 1. Patient does not meet the therefore mentioned inclusion criteria; 2. Patient is currently engaged in a legal procedure concerning disability-related benefits.

Design outcomes

Primary

Measure	Time frame
Primary outcome variables are fatigue severity and functional disabilities. Fatigue severity will be measured with subscale ‘fatigue severity’ of the Checklist Individual Strength (CIS). This indicates the experienced fatigue over the past 2-week period and consists of 8 items that have to be answered to a 7-point scale. The score can be range between 8 to 56. The Sickness Impact profile will be used to measure functional disability in ambulation, home management, mobility, alertness behavior, sleep/rest, work, limitations, social interactions, recreation and pastimes. The eight subscales are added to provide one weighted score of disability (SIP total score).	—

Measure

Time frame

Primary outcome variables are fatigue severity and functional disabilities. Fatigue severity will be measured with subscale ‘fatigue severity’ of the Checklist Individual Strength (CIS). This indicates the experienced fatigue over the past 2-week period and consists of 8 items that have to be answered to a 7-point scale. The score can be range between 8 to 56. The Sickness Impact profile will be used to measure functional disability in ambulation, home management, mobility, alertness behavior, sleep/rest, work, limitations, social interactions, recreation and pastimes. The eight subscales are added to provide one weighted score of disability (SIP total score).

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Secondary

Measure	Time frame
The secondary outcome variables are physical and social disabilities and the level of psychological distress. Physical and social disabilities are measured with the ‘physical functioning’ and ‘social functioning’ subscale of the Medical Outcomes Survey Short Form-36 (SF-36). The scores can range from 0 (maximum limitations) to 100 (no limitations). Psychological distress will be measured with the symptom Checklist 90 (SCL-90). The SCL-90 consists of 90 items scored on a 5-point Likert scale. The total score ranges from 90 to 450. A high total score reflects high psychological distress.	—

Measure

Time frame

The secondary outcome variables are physical and social disabilities and the level of psychological distress. Physical and social disabilities are measured with the ‘physical functioning’ and ‘social functioning’ subscale of the Medical Outcomes Survey Short Form-36 (SF-36). The scores can range from 0 (maximum limitations) to 100 (no limitations). Psychological distress will be measured with the symptom Checklist 90 (SCL-90). The SCL-90 consists of 90 items scored on a 5-point Likert scale. The total score ranges from 90 to 450. A high total score reflects high psychological distress.

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Contacts

Public ContactM. Tummers

Radboud University Nijmegen Medical Centre 4628 Expert Centre Chronic Fatigue P.O. box 9101

M.Tummers@nkcv.umcn.nl+31 (0) 243610048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)