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

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.