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Trial - NCT05212467


Column Value
Trial registration number NCT05212467
Full text link
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05212467

First author
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Helena Liira, MD, PhD

Contact
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

helena.liira@hus.fi

Registration date
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2022-01-28

Recruitment status
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

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
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

• 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.

Number of arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Helsinki University Central Hospital

Inclusion age min
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Finland

Type of patients
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

360

primary outcome
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

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

Notes
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2133, "treatment_name": "Air-program", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2132, "treatment_name": "Hus internet therapy", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]