Clinical trial NCT05212467: AIR-program and HUS Internet Therapy Compared to Treatment as Usual in Functional Disorders and Post Covid-19 Condition
Official title: Amygdala and Insula Retraining (AIR) Program and HUS Internet Therapy Compared to Treatment as Usual in Bodily Stress Syndrome, Fibromyalgia, Post Covid-19, and Chronic Fatigue Syndrome (ME/CFS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Disorders
Post Covid-19
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to one of the three treatment groups
Primary purpose: TREATMENT

Brief summary: This study will compare an Amygdala and insula retraining (AIR) program to an internet therapy developed at Helsinki University Hospital. The study will be a multi-center randomized controlled trial. Study units will be recruited from the Network for Functional Disorders that is hosted by the HUS Clinic for Functional Disorders and potentially later from international collaborators. The trial will clarify whether internet-based non-drug based therapies are helpful in overcoming the central sensitization and the functional disabilities caused by these disorders.

Detailed description: Functional disorders are a challenging group of conditions treated both in primary and secondary care. Recently, mounting evidence shows that central nervous system sensitization is one of the involved mechanisms, giving new treatment opportunities. There are self-management programs and internet therapies that aim at overcoming the central sensitization by creating new neural networks in the brain. This study aims to test whether an Amygdala and insula retraining (AIR) program compared to an internet therapy developed at HUS (Helsinki University Hospital) and treatment as usual (TAU) is effective in the treatment of functional disorders, fibromyalgia, long Covid, and chronic fatigue syndrome (ME/CFS).

The investigators will perform a multi-center randomized controlled trial in volunteering health units and with volunteering patients aiming at 360 patients altogether. The physicians in charge of the patients will be recruited from the Network for Functional Disorders launched by the novel clinic at HUS. The participating centers will receive an introduction in functional disorders, the underlying mechanisms, and treatment opportunities.

For functional disorders, this study applies the ICD-11 primary care code of Bodily stress syndromes (BSS), which covers fibromyalgia, irritable bowel syndrome, multiple chemical sensitivities, and other, both single system and multiorgan functional disorders. In addition, for patients with fibromyalgia, chronic fatigue symptoms, and Post Covid-19 condition, we will apply specific diagnostic criteria. Both primary and secondary care treatment units that manage these disorders can recruit patients.

The studied interventions are an Amygdala and insula retraining (AIR) program and an internet therapy developed at HUS, and patients receive usual care in addition to these interventions. The third study arm consists of treatment as usual for six months after which the patients receive the AIR program or the internet therapy if they so wish. When the participating physicians consider that a patient could benefit from a self-management program, they introduce the trial to the patient. The consenting patient fills in a baseline survey and is followed up at 3, 6, and 12 months with the help of the HUSeCRF (online surveys at the HUS electronic Case Report Form), or research nurse's interviews.

This study will give new insight into the opportunities of self-management programs in the treatment of bodily stress syndromes, fibromyalgia, Post Covid-19, and ME/CFS. The investigators will find out whether the training programs increase patients' functional ability and quality of life as measured on a scale from 0 to 10. These scales and functional ability as measured by WHODAS 2.0 serve as main outcome measures for this study. This trial is the first large-scale randomized trial that assesses these methods developed to overcome the central sensitization of brain. The results will have an impact on the management of these common and often debilitating conditions.

Eligibility criteria: Inclusion Criteria:

* • The criteria of bodily stress syndrome, fibromyalgia, chronic fatigue syndrome, or long Covid fulfilled AND

  * Diagnostic examinations have ruled out the potential somatic reasons for the symptoms AND
  * Disabling symptoms have lasted at least 3 months AND
  * Patient is willing to receive a psychoeducation or brain retraining intervention.

Exclusion Criteria:

* • Patients for whom participation could be overly demanding because of physical constraints (for example, patients who cannot write because of dystonia or bedridden patients)

  * Patients with presence of severe psychiatric and severe somatic disorders, e.g. moderate or severe depression or newly onset cancer for which the study could be overly strenuous.

Primary outcomes:
measure: Change from baseline in functional ability as measured by the WHODAS2.0 instrument at six months.
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: Change from baseline in quality of life as measured by EUROHIS-8
timeFrame: 3, 6 and 12 months
measure: Change from baseline in health related quality of life as measured by 15D
timeFrame: 3, 6 and 12 months
measure: Change from baseline in symptoms as measured by SSD-12 and PHQ-15
timeFrame: 3, 6 and 12 months
measure: Change from baseline in depression as measured by PHQ-9
timeFrame: 3, 6 and 12 months
measure: Change from baseline in anxiety as measured by GAD-7
timeFrame: 3, 6 and 12 months
measure: Change in sleep as measured by ISI
timeFrame: 3, 6 and 12 months
measure: Change in resilience as measured by Resilience Scale-14
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Clinic for Functional Disorders, HUS
city: Helsinki
country: Finland
facility: Clinic for Long Covid, HUS
Study officials:
References: