Chronic Fatigue SyndromeNCT01806246
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
A study testing integrative rehabilitation program in people with Chronic Fatigue Syndrome, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- integrative rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants who meet the diagnostic criteria of chronic fatigue syndrome
- Clinically evaluated, exclude any disease that can explain the chronic fatigue;
- Diagnosed and evaluated within the health region, Central Norway
- With written consent form signed by themselves and their parents.
Who cannot join
- serious comorbidity such as anorexia, psychosis
- serious depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- integrative rehabilitation program
- Keywords
- rehabilitation, adolescent, heart rate variability biofeedback, psychoeducation
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrative rehabilitation programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| integrative rehabilitation program | Experimental | 28 sessions during 12 months with focus on psychoeducation, activity planning, and thoughts and feelings connected to having a serious chronic disease. From week 13 to week 32 a training programme aiming at balancing heart rate variability. Receives: Behavioral: integrative rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue change
assessed by Fatigue Severity Scale
Measured: baseline and 52 weeks
quality of life change
assessed by Inventory of Life Quality for Children and Adolescents
Measured: baseline and 52 weeks
Secondary outcomes (4)
mood change
assessed by Mood and Feelings Questionnaire
Measured: baseline and 52 weeks
change in heart rate variability
Measured: baseline and 52 weeks
school attendance change
Measured: baseline and 52 weeks
general health change
General Health Questionnaire (GHQ-12)
Measured: baseline and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Jozefiak, md phd, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806246
- Sponsor's protocol ID
- 2012/2159
- Status last verified
- Oct 2015
- First submitted
- 1 Mar 2013
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
- ClinicalTrials.gov ID
- NCT01806246
- Acronym / sponsor ID
- 2012/2159
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- rehabilitation, adolescent, heart rate variability biofeedback, psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| integrative rehabilitation program | Experimental | Behavioral: integrative rehabilitation program28 sessions during 12 months with focus on psychoeducation, activity planning, and thoughts and feelings connected to having a serious chronic disease. From week 13 to week 32 a training programme aiming at balancing heart rate variability. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants who meet the diagnostic criteria of chronic fatigue syndrome
- Clinically evaluated, exclude any disease that can explain the chronic fatigue;
- Diagnosed and evaluated within the health region, Central Norway
- With written consent form signed by themselves and their parents.
Key exclusion criteria (2 listed)
- serious comorbidity such as anorexia, psychosis
- serious depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrative rehabilitation program | Behavioural | integrative rehabilitation program |
Primary outcome
fatigue change
Time frame: baseline and 52 weeks
assessed by Fatigue Severity Scale
quality of life change
Time frame: baseline and 52 weeks
assessed by Inventory of Life Quality for Children and Adolescents
4 secondary outcomes
mood change
Time frame: baseline and 52 weeks
change in heart rate variability
Time frame: baseline and 52 weeks
school attendance change
Time frame: baseline and 52 weeks
general health change
Time frame: baseline and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jozefiak, md phd study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrative rehabilitation program in people with Chronic Fatigue Syndrome, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue change (time frame: baseline and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.