|- candidate number||14941|
|- NTR Number||NTR4013|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mei-2013|
|- Secondary IDs||NL 42543.091.12 Commissie Mensgebonden Onderzoek (Arnhem-Nijmegen)|
|- Public Title||The efficacy of Cognitive Behavioural Internet Therapy for adult patients with Chronic Fatigue Syndrome: a randomised controlled trial. |
|- Scientific Title||The efficacy of Cognitive Behavioural Internet Therapy for adult patients with Chronic Fatigue Syndrome: a randomised controlled trial. |
|- ACRONYM||CBIT for CFS|
|- hypothesis||Wider implementation of CBT for CFS is hampered by the fact that the treatment is time consuming for both patient and therapist. Therefore it is important to develop treatment programmes that require less treatment capacity. In the present study we want to test the efficacy of cognitive behavioural internet therapy (CBIT) for adult CFS patients. |
Two versions of CBIT will be offered: one in which patients will receive frequent feedback according to a predefined schedule (protocol driven feedback) and one version in which patients only receive support on demand (support on demand).
|- Healt Condition(s) or Problem(s) studied||Chronic Fatigue Syndrome (CFS), Fatigue|
|- Inclusion criteria||In order to be eligible to participate in this study, patients must meet all of the following criteria: |
* >= 18 years;
* Able to speak, read and write Dutch language;
* Meet the US Center for Disease Control and Prevention criteria for chronic fatigue syndrome (revised 2003);
* Score >= 35 on the Checklist Individual Strength (CIS), subscale fatigue severity;
* Have a total score of >= 700 on the Sickness Impact Profile r_08 (SIPr08);
* Give written informed consent.
|- Exclusion criteria||Patients who meet any of the following criteria will be excluded from participation in this study:
- Engagement in a legal procedure concerning disability-related financial benefits.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-mei-2013|
|- planned closingdate||1-jun-2016|
|- Target number of participants||240|
|- Interventions||Study procedures will be described in order of offering to the patient. |
Baseline assessment T0;
Baseline assessment consists of two visits to our centre and filling in questionnaires. Between these two test moments patients will wear an actometer for 12 days. The mean physical activity score over twelve days will be used to assess the level of physical activity.
The assessments at baseline are part of the standard diagnostic procedure for all referred patients. For this study two questionnaires will be added, namely a questionnaire concerning internet behaviour and use of modern communication tools and the EQ-6d for quality adjusted life years.
After allocation to a condition people will follow the internet therapy for a period of maximally 6 months.
Assessment 2 will follow the same procedure as the baseline assessment. See for a description ‘baseline assessment’. T1 will be assessed 6 months after randomisation.
Face to face CBT
Face to face therapy will be delivered according to the protocol described by Knoop & Bleijenberg (2010). It will be offered to those participants who are severely fatigued and/or disabled at T1. For patients continuing therapy with face to face CBT after the cognitive behavioural internet therapy, we expect fewer sessions are needed for reducing fatigue severity and disabilities to normal, healthy levels. Both interventions (i.e. CBIT and possible face to face CBT) will be carried out by the same therapist.
Assessment consists of web-based questionnaires without wearing the actometer. T2 will be assessed at minimal 6 months after the session with the therapist about results of T1.
Drop-outs will be assessed directly after they drop-out and will be asked to fill in assessments at T1 and/or T2.
|- Primary outcome||The primary outcome measure is fatigue severity assessed with the CIS subscale ‘fatigue severity’. |
|- Secondary outcome||Secondary outcome measures are:
- Level of disabilities assessed with the total score of the Sickness Impact Profile and Short Form 36 Health Survey subscale ‘physical functioning’ ;|
- Level of psychological distress (total score on Symptom CheckList-90);
- Proportion of patients with clinical significant improvement with respect to fatigue severity. Clinical significant improvement is defined as a reliable change index > 1.96 (Jacobson & Truax, 1991) between baseline and T1, and a score of < 35 on the CIS Fatigue Severity subscale at T1;
- Quality Adjusted Life Years (Euro Qol Group-6D);
- Number of sessions per patient;
- Therapist time per patient.
|- Timepoints||Fatigue severity will be measured with the subscale ‘fatigue severity’ of the Checklist Individual Strength (CIS).
Timepoints: baseline, T1 (6 months after randomization), T2 (6 months after start of face to face CBT).
Secondary outcome measures will be measures with; at timepoints:
• Level of disabilities ((Sickness Impact Profile total score and Short Form 36 Health Survey (=RAND-36 in Dutch) subscale physical functioning)). Timepoints: baseline, T1, T2.
• Level of psychological distress (total score on Symptom CheckList-90). Timepoints: baseline, T1, T2.
• Proportion of patients with clinical significant improvement on fatigue severity. Clinical significant improvement is defined as a reliable change index > 1.96 (Jacobson & Truax, 1991) between baseline and T1/T2, and a score of < 35 on the CIS Fatigue Severity subscale at T1/T2.
Timepoints: T1, T2.
• Quality Adjusted Life Years (Euro Qol Group-6D). Timepoints: baseline, T1, T2.
• Number of sessions per patient. Timepoints: T2.
• Therapist time per patient (registered by therapist). Timepoints: T1 and number of sessions.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dhr. A.L. Janse|
|- CONTACT for SCIENTIFIC QUERIES||PhD. J.A. Knoop|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre|
(Source(s) of Monetary or Material Support)
|Radboud University Nijmegen Medical Centre|
|- Brief summary||Cognitive behavioural therapy (CBT) for Chronic fatigue syndrome (CFS) is an effective but intensive treatment. CBT for CFS is directed at changing fatigue-related cognitions and behaviours that perpetuate the fatigue and disabilities. A subgroup of patients fully recovers during treatment. Wider implementation of CBT is hampered by a limited treatment capacity. Therefore, many CFS patients don’t receive (optimal) treatment.|
To broaden treatment capacity, less intensive interventions have been developed. Results from a previous RCT showed that a less intensive treatment significantly reduced fatigue and related disabilities in a subgroup op CFS-patient.
For adults, CBIT has been developed and will be focus of this present study. The efficacy of cognitive behavioural internet therapy (from here on CBIT) for adult CFS patients will be studied. We will test how much feedback from the therapist is needed for patients to profit from CBIT. We developed two versions of CBIT: one in which patients will receive frequent feedback according to a predefined schedule (protocol driven feedback) and one version in which patients only receive support on demand (support on demand).
Phase two of this study consists of face to face CBT for those who didn’t profit enough of CBIT and for the waiting control group. CBT will be offered and assessed for its efficiency and efficacy in this randomized non-inferiority trail. Possibly, after CBIT, fewer individual face to face sessions will be needed to significantly reduce fatigue and disabilities.
|- Main changes (audit trail)||6-sep-2014:
There have been three changes made in de study after its start: |
1. Quality adjusted life years will not be assessed or analyzed due to limited resources.
2. Both web-based CBT formats will also be compared with respect to the therapist time needed to deliver the intervention.
3. The second part of the study consists of a randomised noninferiority trial. In this trial we will test if each of the two forms of stepped care (one of the CBIT formats followed with face to face CBT if patients did not profit enough from the web-based intervention CBIT) are non-inferior to care as usual (face to face CBT after the waiting period) with respect to the effect on the primary outcome measure, fatigue severity. A power analysis showed that the number of participants will have to be increased for this randomised noninferiority trial. This study will therefore be separately registered in the trial register. - AB
|- RECORD||31-mei-2013 - 6-sep-2014|