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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Care as Usual | Active comparator | These patients receive the standard treatment provided to this patient group at the respective study site. Receives: Other: Care as usual |
| Mind-Body Reprogramming Therapy | Experimental | These 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.
Chalder Fatigue Questionnare (CFQ)
Total score on the CFQ, 0-33
Measured: End of treatment at 3 months post-baseline.
Secondary outcomes (2)
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.
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.
- First posted6 Nov 2026
- Study start9 Nov 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic FatigueStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pedersen, Oslo University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07923539
- Acronym / sponsor ID
- MiRA / 940104
- Conditions
- Chronic Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | Active comparator | Other: Care as usualThese patients receive the standard treatment provided to this patient group at the respective study site. |
| Mind-Body Reprogramming Therapy | Experimental | Behavioral: Mind-Body Reprogramming TherapyThese patients receive Mind-Body Reprogramming Therapy (MBRT), as described in the attached protocol |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Mind-Body Reprogramming TherapyAlso: MBRTMind-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. | Behavioural | Mind-Body Reprogramming Therapy |
| Care as usualStandardized advice includes regular sleep routines, graded activity exposure, healthy meals, and rest techniques (given face-to-face and in writing). Otherwise care as usual. | Other | Care as Usual |
Primary outcome
Chalder Fatigue Questionnare (CFQ)
Time frame: End of treatment at 3 months post-baseline.
Total score on the CFQ, 0-33
2 secondary outcomes
The PROMIS-25 questionnaire, supplemented by four additional questions on sleep.
Time frame: End of treatment at 3 months post-baseline.
School absence
Time frame: End of treatment at 3 months post-baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Fatigue
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Not yet recruiting
Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in COPD Patients
Chronic Obstructive Pulmonary Disease
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
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; AzTrials last refreshed its copy on 6 Nov 2026.