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

NCT05212467 | Unknown

• 1 other identifier: HUS/2239/2021
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Disorders; Post Covid-19

Outcome Measures

Primary Outcomes (1)

• Change from baseline in functional ability as measured by the WHODAS2.0 instrument at six months.

  3, 6 and 12 months

Secondary Outcomes (7)

• Change from baseline in quality of life as measured by EUROHIS-8

  3, 6 and 12 months

• Change from baseline in health related quality of life as measured by 15D

  3, 6 and 12 months

• Change from baseline in symptoms as measured by SSD-12 and PHQ-15

  3, 6 and 12 months

• Change from baseline in depression as measured by PHQ-9

  3, 6 and 12 months

• Change from baseline in anxiety as measured by GAD-7

  3, 6 and 12 months

Study Arms (3)

AIR-program

ACTIVE COMPARATOR

• 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

Behavioral: AIR-program; Behavioral: Treatment as usual

HUS Internet therapy

ACTIVE COMPARATOR

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.

Behavioral: HUS Internet therapy; Behavioral: Treatment as usual

Treatment as usual

PLACEBO COMPARATOR

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.

Behavioral: Treatment as usual

Interventions

AIR-program BEHAVIORAL

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

AIR-program

HUS Internet therapy BEHAVIORAL

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

HUS Internet therapy

Treatment as usual BEHAVIORAL

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

AIR-program; HUS Internet therapy; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Clinic for Functional Disorders, HUS

Helsinki, 00029, Finland

RECRUITING

Clinic for Long Covid, HUS

Helsinki, 00029, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 39937805 DERIVED

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Helena Liira, MD, PhD

CONTACT

+358 50 577 1351; helena.liira@hus.fi

Jari Arokoski, Prof

CONTACT

+358 50 428 7901; jari.arokoski@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Patients are randomized to one of the three treatment groups

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 28, 2022
• Study Start: January 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

FI (2)