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Not yet recruitingNCT07923539MiRAUpdated Nov 6, 2026

Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue

An interventional study of Mind-Body Reprogramming Therapy and Care as usual in Chronic Fatigue, sponsored by Oslo University Hospital. Not yet recruiting. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Chronic Fatigue

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03

In context

Fatigue

2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.

This study's planned enrollment of 210 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 12-18 years at the time of .
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Active comparator
    Care as Usual

    These patients receive the standard treatment provided to this patient group at the respective study site.

    Other: Care as usual

  • Experimental
    Mind-Body Reprogramming Therapy

    These patients receive Mind-Body Reprogramming Therapy (MBRT), as described in the attached protocol

    Behavioral: Mind-Body Reprogramming Therapy

Interventions

  • BehavioralMind-Body Reprogramming Therapy

    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.

    Also known as: MBRT

  • OtherCare as usual

    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.

06

What researchers measure

Primary outcomes

  1. Chalder Fatigue Questionnare (CFQ)

    Total score on the CFQ, 0-33

    Time frame: End of treatment at 3 months post-baseline.

Secondary outcomes

  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)

    Time frame: End of treatment at 3 months post-baseline.

  2. School absence

    Percentage of school days missed due to illness.

    Time frame: End of treatment at 3 months post-baseline.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.

Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 18 months is above that.

Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Nov 9, 2026
Primary completionEst.
May 30, 2028
CompletionEst.
Sep 30, 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07923539
Responsible party
Maria Pedersen (Senior Consultant, Oslo University Hospital) — Principal investigator
First posted
Nov 6, 2026
Start date
Nov 9, 2026 (estimated)
Primary completion
May 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Maria Pedersen, MD, PhD
Contact
maria.pedersen@medisin.uio.no
+47 95771170

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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