Ambulatory activity-based feedback (ABF) : (Netherlands) 2008 - 2011

[Sly Saint]

I came across this on the Cochrane Central Database but cannot find any publication.

Original Title:

1. Optimalization of Cognitive Behavioral Therapy (CBT) for CFS patients in rehabilitation by means of ambulatory activity‐based feedback (ABF) ‐ Ambulatory activity‐based feedback (ABF)

Abstract

INTERVENTION: 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'.

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

PRIMARY OUTCOME: The primary outcome parameters are:; ; ‐ Experienced fatigue ; ; ‐ Physical functioning

SECONDARY OUTCOME: 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)’.

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; ‐ 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.

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

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

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

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; Other outcome measures are:

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; ‐ 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.

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

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

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

https://www.cochranelibrary.com/central/doi/10.1002/central/CN-01825303/full#abstract

this is the WHO registration
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NTR1513

and the Netherlands trial register
https://www.trialregister.nl/trial/1452

Background of the study:

The chronic fatigue syndrome (CFS) is characterized by chronic fatigue lasting for at least 6 months, and other additional symptoms. CFS patients do often have a disturbed balance in their pattern of physical activities. The current treatment for CFS in rehabilitation centre 'Het Roessingh' consists of cognitive behavioural therapy (CBT). The aim of this study is to investigate the additional value of 'ambulant physical activity based feedback (ABF)' to the standard rehabilitation program for CFS. It is expected that the CFS patient gets more insight in his or her physical activity pattern, intentions develops to change the behaviour, and really changes the behaviour resulting in a reduction of the CFS complaints.

Objective of the study:

The primary goal is to investigate if CBT plus ABF has an additional reducing effect on experienced fatigue and an additional positive effect on physical functioning, in comparison to CBT alone. Secondary goals are to investigate if CBT plus ABF has additional reducing effects on experienced disabilities and social functioning, and an additional positive effect on psychological determinants in comparison to CBT alone. Furthermore, the influence of ABF on the awareness of the physical activity level of the CFS patient will be studied. Also, a change in the behavioural intention to achieve a balance in the physical activity level will be studied, and if ABF really is obeyed. Finally, the feedback system will be evaluated by means of usability satisfaction, usefulness and utility.

Study design:

The study design is a 'randomized controlled trial (RCT)' in which the intervention group receives the standard treatment (CBT) plus ABF and the control group the standard treatment (CGT) alone.

Study population:

The study population shall consist of CFS patients with an age of 18 years or older and be eligible for the group treatment of cognitive behavioural therapy in the pain division of 'Het Roessingh'.

Intervention:

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

eta: does anyone know anything about this trial?

Of interest because of it using objective measures as well as the usual subjective stuff.

 

[Invisible Woman]

Right. So completely ignores the issues with brainfog for a start.