Adolescent Chronic Fatigue SyndromeNCT02336126
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
A study testing Biopsychological intervention in people with Adolescent Chronic Fatigue Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Chronic Fatigue Syndrome
- What is being tested?
- Biopsychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Jan 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of chronic fatigue syndrome
- Significant school absenteeism
- Above 12 years of age and below 18 years of age
Who cannot join
- Other diseases or life events that might explain chronic fatigue
- Bed-ridden
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.
The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.
- Conditions
- Adolescent Chronic Fatigue Syndrome
- Being tested
- Biopsychological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsychological interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Biopsychological intervention | Experimental | Not described Receives: Behavioral: Biopsychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder fatigue score
Measured: Up to 3 months after inclusion
Secondary outcomes (2)
Patients' experiences (semistructured interview)
Qualitative data, further analysed by thematic structural analysis
Measured: Up to 3 months after inclusion
Quality of Life (PedsQL)
Measured: Up to 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336126
- Sponsor's protocol ID
- BIOPSYCH
- Status last verified
- Jan 2015
- First submitted
- 22 Aug 2014
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
- ClinicalTrials.gov ID
- NCT02336126
- Acronym / sponsor ID
- BIOPSYCH
- Conditions
- Adolescent Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Jan 2015 (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.
This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.
The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsychological intervention | Experimental | Behavioral: Biopsychological intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic fatigue syndrome
- Significant school absenteeism
- Above 12 years of age and below 18 years of age
Key exclusion criteria (2 listed)
- Other diseases or life events that might explain chronic fatigue
- Bed-ridden
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 |
|---|---|---|
| Biopsychological intervention | Behavioural | Biopsychological intervention |
Primary outcome
Chalder fatigue score
Time frame: Up to 3 months after inclusion
2 secondary outcomes
Patients' experiences (semistructured interview)
Time frame: Up to 3 months after inclusion
Quality of Life (PedsQL)
Time frame: Up to 3 months after inclusion
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 18 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsychological intervention in people with Adolescent Chronic Fatigue Syndrome, run by Oslo University 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 3 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 18 Apr 2016. 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?
Chalder fatigue score (time frame: Up to 3 months after inclusion). 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 18 Apr 2016.