Official Title
Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
Brief Summary

This randomized controlled trial (RCT) with 160 patients suffering from fatigue afterCOVID-19 infection aims to investigate the effectiveness of the unguided digitaltherapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male,female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months sincethe last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the ChalderFatigue Scale (CFQ-11), consent to participation, and sufficient German language skills.Exclusion criteria are a known psychiatric or somatic condition that can explain thefatigue and current participation in a multidisciplinary rehabilitation program aimed toameliorate the consequences of COVID-19.Patients will be randomized and allocated to either an intervention group, in which theywill receive access to vimida in addition to treatment as usual (TAU; n=80), or to acontrol group, in which they will receive access to TAU only (n=80).The primary endpoint will be fatigue symptoms with three months post-allocation (T1)being the primary time point for assessment of effectiveness. Six months post-allocation(T2) will be used as follow-up assessment of endpoints. Secondary endpoints will bedepressive symptoms, mental health-related quality of life, work/social functioning,somatic symptoms, and anxiety symptoms.

Detailed Description

Not Provided

Recruiting
Long Covid
Post COVID-19 Condition

Behavioral: vimida

Participants will receive access to the digital health intervention vimida in addition to
TAU.

Eligibility Criteria

Inclusion Criteria:

- male, female or non-binary

- age ≥ 18

- diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with
G93.3), secured via a telemedical visit

- ≥ 3 months since COVID-19 infection that preceded fatigue symptoms

- elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11

- consent to participation

- sufficient knowledge of the German language

Exclusion Criteria:

- known somatic or psychiatric condition that can explain the fatigue (e.g., cancer,
multiple sclerosis, severe depression)

- current participation in a multidisciplinary rehabilitation program aimed at
ameliorating the consequences of COVID-19

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

GAIA
Hamburg, Germany

Investigator: Gitta A Jacob, PhD
Contact: +49.40.349930-374
gitta.jacob@gaia-group.com

Contacts

Gitta A. Jacob, PhD
+49.40.349930-374
gitta.jacob@gaia-group.com

Antje Riepenhausen, PhD
antje.riepenhausen@gaia-group.com

Johanna Schröder, PhD, Principal Investigator
Medical School Hamburg

NCT Number
MeSH Terms
COVID-19