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.
Not Provided
Behavioral: vimida
Participants will receive access to the digital health intervention vimida in addition to
TAU.
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
GAIA
Hamburg, Germany
Investigator: Gitta A Jacob, PhD
Contact: +49.40.349930-374
gitta.jacob@gaia-group.com
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