AIR-program and HUS Internet Therapy Compared to Treatment as Usual in Functional Disorders and Post Covid-19 Condition

NCT ID: NCT05212467

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Functional Disorders; Post Covid-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AIR-program

• The Amygdala and insula retraining program consists of novel brain retraining approaches focused on hypothetically interrupting and retraining the conditioned defensive hyper-stimulation of the sympathetic nervous system and aspects of the immune system by the amygdala and insula, to bring the brain and body back to homeostasis. It includes supportive techniques such as breathing, meditation, and neurolinguistic programming. The patients are invited to an online program of video session and eight weekly 2 h webinar sessions followed by three monthly sessions. The patients are assigned to do daily homework that takes approximately 15 to 20 min to complete

Group Type: ACTIVE_COMPARATOR

AIR-program

Intervention Type: BEHAVIORAL

This is a guided self management program that is added on the treatment as usual.

Treatment as usual

Intervention Type: BEHAVIORAL

The patients receive routine care from their physician which may include drugs, visits or rehabilitation

HUS Internet therapy

The HUS internet therapy for bodily stress syndromes (iHUSbss) includes psychoeducation about autonomic nervous system and of the effects of patient's own thinking and action on the nervous system. The exercises aim at relaxing the body, at novel ways to observe the symptoms, and at developing acceptance and self-compassion. The program includes exercises that are done regularly in everyday life.

Group Type: ACTIVE_COMPARATOR

HUS Internet therapy

Intervention Type: BEHAVIORAL

This is a guided self management program that is added on the treatment as usual.

Treatment as usual

Intervention Type: BEHAVIORAL

The patients receive routine care from their physician which may include drugs, visits or rehabilitation

Treatment as usual

The patients may have appointments with their physician, physiotherapist, or another health professional, and they may attend group interventions. If possible, medication is kept the same during the intervention and three months afterwards. If there is need to change the medication during the trial, the changes will be recorded. Appointments with health professionals and attendance in group interventions are monitored.

Group Type: PLACEBO_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

The patients receive routine care from their physician which may include drugs, visits or rehabilitation

Interventions

AIR-program

This is a guided self management program that is added on the treatment as usual.

Intervention Type: BEHAVIORAL

HUS Internet therapy

This is a guided self management program that is added on the treatment as usual.

Intervention Type: BEHAVIORAL

Treatment as usual

The patients receive routine care from their physician which may include drugs, visits or rehabilitation

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helena Liira

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinic for Functional Disorders, HUS

Helsinki, , Finland

Site Status: RECRUITING

Clinic for Long Covid, HUS

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Helena Liira, MD, PhD

Role: CONTACT

helena.liira@hus.fi

+358 50 577 1351

Jari Arokoski, Prof

Role: CONTACT

jari.arokoski@hus.fi

+358 50 428 7901

Facility Contacts

Markku Sainio, MD, PhD

Role: primary

markku.sainio@hus.fi

+358 40 569 3186

Helena Liira, MD, PhD

Role: primary

helena.liira@hus.fi

+358 50 577 1351

References

Vangelova-Korpinen V, Liira H, Kurki SN, Sainio M, Malmivaara A, Kanerva M, Stenberg JH, Varonen M, Venalainen M, Vuorela P, Arokoski J. Effectiveness of mindfulness-based online therapy or internet-delivered cognitive behavioral therapy compared with treatment as usual among patients with persistent somatic symptoms: Protocol for a randomized controlled trial. PLoS One. 2025 Feb 12;20(2):e0316169. doi: 10.1371/journal.pone.0316169. eCollection 2025.

Reference Type: DERIVED

PMID: 39937805 (View on PubMed)

Other Identifiers

HUS/2239/2021

Identifier Type: -

Identifier Source: org_study_id