Condition category
Haematological Disorders
Date applied
27/12/2016
Date assigned
11/04/2017
Last edited
11/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Paediatric immune dysregulation disorders (PIDD) are a group of childhood disorders where the immune system does not function properly. This may involve autoimmune rheumatic diseases (where the immune system mistakenly attacks healthy joints) and immune deficiencies (where the immune system’s ability to fight infections and disease is compromised or entirely absent). Chronic severe fatigue is a frequently reported complaint amount adolescents with PIDD. It involves extreme, persistent or recurrent fatigue (extreme tiredness) which has lasted for at least three months. It has a profound, debilitating effect on daily life and can lead to a decrease in school attendance and physical activity in those affected. The relationship between fatigue and disabilities among PIDD patients suggests that fatigue may be a viable target for therapeutic interventions designed to improve physical functioning and school participation. One approach in the treatment of severe fatigue that is promising is cognitive behaviour therapy (CBT), a type of talking therapy that aims to change the way people think and behave. The aim of this study is to look at the effectiveness of a web-based CBT treatment programme for adolescent PIDD patients with chronic fatigue at reducing fatigue and disabilities.

Who can participate?
Patients aged between 11 and 18 who have a PIDD and have been suffering from severe fatigue for at least three months.

What does the study involve?
All participants take part in the web-based CBT programme for six months. They are randomly allocated to start receiving the programme at different timepoints. The programme involves 19 interactive modules which include topics such as regulation of sleep-wake pattern; adjustment to a chronic (long-term) disease and managing the uncertainty about disease progression; adjustment to chronic (long-term) pain; reformulation of fatigue related thought patterns; activity regulation and increasing physical activity; and improving social interactions in relation to fatigue. Within a treatment module the participant is asked to keep several journals, answer questions and do several assignments. All answers are sent to the therapist that participants are in weekly email contact with. The main emphasis in the treatment part will be on the setting of goals in behavioural terms to motivate a change in behaviour and accompanying them to normal daily activities including full time education. Patients work toward achieving these goals throughout the programme. At the start of the study and then every week until four weeks after the programme ends (including the time before they start the programme), participants complete a range of questionnaires about their fatigue, pain and disability levels.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in their fatigue and disability levels. There are no anticipated risks involved with participating in this study.

Where is the study run from?
Wilhelmina Children's Hospital, University Medical Center Utrecht (Netherlands)

When is the study starting and how long is it expected to run for?
August 2016 to January 2018

Who is funding the study?
Univerisity Medical Center Utrecht (Netherlands)

Who is the main contact?
Dr Elise van de Putte
e.vandeputte@umcutrecht.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elise van de Putte

ORCID ID

Contact details

Wilhelmina Children's Hospital (part of University Medical Center Utrecht)
Postbox 85090
Utrecht
3508 AB
Netherlands
+31 88 75 545 55
e.vandeputte@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL56462.041.16

Study information

Scientific title

Pilot study: web-based treatment of severe fatigue among adolescent patients with an immune dysregulation disorder: a single-case experimental design with multiple measurements

Acronym

FITNET-plus

Study hypothesis

The main aim of this pilot study is to estimate the feasibility of web-based cognitive behaviour therapy (CBT) for severe disabling fatigue among a limited number of adolescent patients with an immune dysregulation disorder. The secondary aim is to estimate intervention effects of web-based CBT for fatigue, associated pain, and disabilities.

Ethics approval

University Medical Center Utrecht, 02/08/2016, ref: 16-237-M, NL56462.041.16

Study design

Single-centre randomised stepped wedge trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Immune dysregulation disorder

Intervention

All participants will be randomized to receive the web-based cognitive behaviour therapy intervention after 7, 8, 10, 11, 13 (3x), 16, 18 or 24 weeks of randomization (the participants are their own controls during waiting time). The duration of the cognitive behavioural programme is limited to 6 months and the effect will be monitored during the waiting time and the intervention by weekly questionnaires.

The web-based programme is developed for both the adolescents and the parents. The programme consists of two parts, a psycho-educational part and a cognitive behavioural part consisting of 19 treatment modules. The therapist activates one or more treatment modules per week, dependent on the progress of the participant. Within a treatment module the participant will keep several journals, answer questions and do several assignments. All answers are sent to the therapist, with whom a weekly email contact will be realised.

The follow-up duration is four weeks and will be measured by weekly questionnaires and finished by a follow-up assessment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Fatigue severity is measured with the fatigue severity scale of the CIS-20 weekly from baseline assessment the end of follow up (four weeks).

Secondary outcome measures

1. School presence is expressed in attended hours / obliged hours * 100% last two weeks measured weekly from baseline assessment the end of follow up (four weeks)
2. Physical functioning is measured with the physical functioning scale of the CHQ weekly from baseline assessment the end of follow up (four weeks)
3. Pain is measured with the with the VAS scores for pain (with scores ranging from 0-100 mm) weekly from baseline assessment the end of follow up (four weeks)

Overall trial start date

22/08/2016

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age of 11.5 - 18 years old
2. Able to speak, read, and write Dutch
3. Diagnosed with JIA, JDM or CVID
4. Being severely fatigued for at least 3 months (CIS fatigue ≥ 40)
5. Physical functioning subscale (Child Health Questionnaire) score ≤ 85 and/or school absence > 10%
6. At least 3 months before treatment on stable medication (type and dosage)
7. Diagnosed with unexplained fatigue by the general paediatrician

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Suspicion of active disease requiring adaptation of treatment (at the time of inclusion) or a possible visit to the paediatric rheumatologist (during treatment)
2. Cognitive impairment, estimated IQ <70
3. A somatic cause assessed by the general paediatrician or co-morbid psychiatric disorder based on questionnaires that can explain fatigue at baseline assessment before the start of CBT
4. An anxiety score above 44 on the Spielberger State-Trait Anxiety Inventory for Children (STAIC), (average score of Dutch healthy adolescents plus 2 SD)
5. A depression score above 15 on the Children’s Depression Inventory (CDI), (average score of Dutch healthy adolescents plus 2 SD)
6. Presence of suicidal risk, as assessed by CDI and general paediatrician
7. Receiving treatment for a psychiatric disorder at time of inclusion
8. No availability of computer with internet access

Recruitment start date

02/08/2016

Recruitment end date

01/01/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

Wilhelmina Children's Hospital (part of Univerisity Medical Center Utrecht)
Postbox 85090
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht

Sponsor details

Postbox 85090
Utrecht
3508 AB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Univerisity Medical Center Utrecht

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication is in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Ms. Linde Nijhof (l.n.nijhof@umcutrecht.nl)

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes