AzTrials
AzTrials

Chronic FatigueMiRANCT07923539

Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue

A study testing Mind-Body Reprogramming Therapy and Care as usual in people with Chronic Fatigue, run by Oslo University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic fatigue that cannot be explained by ongoing exertion or alleviated by rest is characterized by disabling fatigue accompanied with symptoms like pain, sleep problems, cognitive difficulties and more. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Chronic Fatigue
What is being tested?
Mind-Body Reprogramming Therapy and Care as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
9 Nov 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age 12-18 years at the time of informed consent.
  • Referred to specialist care at Oslo University Hospital (OUS) or Akershus University Hospital (Ahus) due to chronic fatigue.
  • Persistent fatigue for at least six months, with associated symptoms causing significant impairment in daily functioning (e.g. school attendance, physical activity or social participation).
  • Able to provide written informed consent in accordance with the study protocol.

Who cannot join

  • Other chronic medical conditions, demanding life circumstances, or concomitant medication/substance use considered likely to explain the persistent symptoms and associated functional impairment.
  • Pregnancy.
  • Bedridden status.
  • Insufficient Norwegian language proficiency to participate in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maria Pedersen, MD, PhD contact

+47 95771170

maria.pedersen@medisin.uio.no

About this study

Official title: Effectiveness of a Mind-Body Reprogramming Therapy vs. Care as Usual for Adolescents Aged 12-18 With Chronic Fatigue: A Randomized Controlled Trial.

Chronic fatigue that cannot be explained by ongoing exertion or alleviated by rest is characterized by disabling fatigue accompanied with symptoms like pain, sleep problems, cognitive difficulties and more. This type of chronic fatigue is a global health challenge, affecting many individuals in the adult and the adolescent populations. For adolescents, the symptoms may have detrimental effects on school functioning and social participation during a developmental period marked by pivotal maturation. Thus, providing effective treatment for this condition is highly warranted.

The primary objective of the study is to determine whether MBRT given to adolescents with chronic fatigue can reduce fatigue, compared with CAU. Primary outcome is the evaluation of fatigue symptoms on the Chalder Fatigue Questionnaire (CFQ). Secondary objectives are to determine intervention effects on health-related quality of life, pain, school attendance, physical- and social functioning, anxiety, depression and sleep (see Table 1). Other objectives comprise factors that might influence the treatment, like the adolescents' level of neuroticism and self-efficacy, and the parents' level of health anxiety by proxy. In addition, qualitative interviews will be conducted with a subset of participants who have received MBRT, to explore their experiences of the intervention, perceived helpfulness, and what they believe contributed to any changes they may have experienced.

Read more

The study is a randomized controlled trial where MBRT for adolescents is compared with CAU (Figure 1). Eligible participants are adolescents aged 12 to 18 years with chronic fatigue lasting six months or more, accompanied by a level of functional impairment that significantly limits their ability to engage in normal social, recreational or educational activities.

Participants will be recruited through referrals from general practitioners and hospital services to either Akershus University Hospital or Oslo University Hospital. At the hospital, all referred patients will go through a screening assessment, which includes clinical examination and blood sampling. This screening assessment will be conducted during the same symptom presentation as at baseline (T1). The physician will decide whether more examinations are needed for a proper clinical assessment. With the test results at hand, the physician will evaluate the predefined inclusion and exclusion criteria. All eligible patients will be contacted and a total of 210 patients will be enrolled. Included participants will complete a questionnaire and be randomized to either MBRT or CAU, this will be regarded as the official baseline (T1). For the participants, MBRT consists of an initial session with a physician for a brief intervention, followed by 4 to 6 sessions with a psychologist or psychiatrist. The adolescent's parents participate in the brief intervention and are also offered an individual session with the psychologist or psychiatrist. The sessions are scheduled close together in time to build and maintain therapeutic momentum. This is followed by a pause of approximately four weeks before the booster session. Primary endpoint assessment is at three months (T2). Total follow-up period is six months (T3). The qualitative interviews with a strategically selected subset of participants who have received MBRT will be conducted after T2. Interviews will take place at Oslo University Hospital, digitally, or by telephone. Recruitment for the interviews will begin once half of the total study sample has been enrolled. At that point, all participants randomized to the MBRT arm will be invited to take part in the qualitative study and a separate informed consent will be obtained. Using a purposive sampling approach to capture variation in age, gender, and treatment response, interviews will continue until approximately 20 adolescents and their parents have been interviewed.

Conditions
Chronic Fatigue
Being tested
Mind-Body Reprogramming Therapy, Care as usual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind-Body Reprogramming TherapyBehavioural

    Also called MBRT

    Mind-Body Reprogramming Therapy for adolescents (MBRT) will consist of 5-7 face-to-face meetings with medical doctor (1 encounter) and psychiatrist/psychologist (5-7 encounters) as well as unlimited access to designated digital resources.

  • Care as usualOther

    Standardized advice includes regular sleep routines, graded activity exposure, healthy meals, and rest techniques (given face-to-face and in writing). Otherwise care as usual.

Study groups in NCT07923539
Study groupRoleWhat they receive
Care as UsualActive comparatorThese patients receive the standard treatment provided to this patient group at the respective study site.
Receives: Other: Care as usual
Mind-Body Reprogramming TherapyExperimentalThese patients receive Mind-Body Reprogramming Therapy (MBRT), as described in the attached protocol
Receives: Behavioral: Mind-Body Reprogramming Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chalder Fatigue Questionnare (CFQ)

    Total score on the CFQ, 0-33

    Measured: End of treatment at 3 months post-baseline.

Secondary outcomes (2)
  1. The PROMIS-25 questionnaire, supplemented by four additional questions on sleep.

    Each individual subscale of the questionnaire represents a separate secondary outcome (Physical Function, Anxiety, Depressive Symptoms, Fatigue, Peer Relationships, and Pain)

    Measured: End of treatment at 3 months post-baseline.

  2. School absence

    Percentage of school days missed due to illness.

    Measured: End of treatment at 3 months post-baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start9 Nov 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923539
Sponsor's protocol ID
940104
Other IDs
2026083
Acronym
MiRA
Status last verified
Nov 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mind-Body Reprogramming Therapy and Care as usual in people with Chronic Fatigue, run by Oslo University Hospital.

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 4 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Pedersen, MD, PhD (+47 95771170, maria.pedersen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chalder Fatigue Questionnare (CFQ) (time frame: End of treatment at 3 months post-baseline.). 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 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in