Ambulatory activity-based feedback (ABF)

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR1513
• Date of registration: 29/10/2008
• Primary sponsor: Roessingh Research and Development b.v.
• Public title: Ambulatory activity-based feedback (ABF)
• Scientific title: Optimalization of Cognitive Behavioral Therapy (CBT) for CFS patients in rehabilitation by means of ambulatory activity-based feedback (ABF) - Ambulatory activity-based feedback (ABF)
• Date of first enrolment: 10/11/2008
• Target sample size: 78
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1513
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: R.M.H. Evering

• Name: R.M.H. Evering

Key inclusion & exclusion criteria

Inclusion criteria: 1. Referred by a physician with the diagnose CFS

2. CIS20 subscale fatigue >35

3. Age of 18 years or older

4. Willing to and capable, to participate in the clinical rehabilitation program
Exclusion criteria: 1. Current alcohol or drug addiction

2. Enforced or negative motivation to participate in the rehabilitation program (for instance, focussed on the acquirement of facilities)

3. CVS patiënt is focussed on another diagnosis related to the complaints of fatigue

4. Current lawsuit which could hamper the revalidation proces

5. Dominant psychopathology (conversion, psychosis, anxiety, serious depression)

6. Insufficient control of the Dutch language

7. Extensive cognitive disturbances (diagnosed by a psychologist or rehabilitation physician)

8. Serious psychosocial problems with an acute nature (for instance; decease of a relative, divorce, etc.)

9. CFS patiënt is insufficient to instruct and/or not capable to participate in a group)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Chronic Fatigue Syndrome (CFS), Cognitive behavior therapy, Myalgic encephalomyelitis

Intervention(s)

The intervention will consist of the distribution of ambulant feedback on the phyical activity level by using a microcomputer of pocket size and a accelerometer.
The intervention on the physical activity level shall be given in 4 bloks of 9 days in the home situation, dispersed between the weeks of treatment with clinical admission in 'Het Roessingh'.

Primary Outcome(s)

The primary outcome parameters are:

- Experienced fatigue

- Physical functioning

Secondary Outcome(s)

Secundary outcome parameters are:

- Outcome parameters which measure perceived limitations, social functioning, self efficacy and catastrophizing. These are measured by means of 'patient specific complaints (PSC)', 'self efficacy scale (SES)' and the ?Jacobsen fatigue catastrophising scale (J-FCS)?.

- Behavioural determinants, which could influence the actual compliance to the given feedback to achieve a balans in the physical activity pattern, will be evaluated by means of a self composed questionnaire.

- the physical activity level will be measured objectively and subjectively by means of an accelerometer and the Baecke questionnaire, respectively.

- The physical activity level, expectencies to and experiences with the feedback will be scored with a number between 1 till 10 on the PDA.

Usability satisfaction, usability and utility of the feedback system will be evaluated with a self composed questionnaire (only in the intervention group).



Other outcome measures are:

- Demographic characteristics of the participants (age, gender, work status, sick leave/disability pension, civilian status, duration of complaints, education level, and usage of medicines) will be obtained by means of the standard intake questionnaire in favour of the treatment.

- Psychological condition will be evaluated during the intake by means of the 'SCL90'.

- Causal attributions (CAL) will be evaluated during the intake by means of the 'causal attribution list (CAL)'.

Secondary ID(s)

NL249.044.08

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development