Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue (MiRA)

November 2, 2026 updated by: Maria Pedersen, Oslo University Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.
Experimental: Mind-Body Reprogramming Therapy

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

Other Names:
  • MBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chalder Fatigue Questionnare (CFQ)
Time Frame: End of treatment at 3 months post-baseline.

Total score on the CFQ, 0-33
End of treatment at 3 months post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The PROMIS-25 questionnaire, supplemented by four additional questions on sleep.
Time Frame: End of treatment at 3 months post-baseline.

Each individual subscale of the questionnaire represents a separate secondary outcome (Physical Function, Anxiety, Depressive Symptoms, Fatigue, Peer Relationships, and Pain)
End of treatment at 3 months post-baseline.
School absence
Time Frame: End of treatment at 3 months post-baseline.

Percentage of school days missed due to illness.
End of treatment at 3 months post-baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 9, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 940104
  • 2026083 (Other Grant/Funding Number: South-Eastern Norway Regional Health Authority (HSØ))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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