This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic 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 since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19. Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control 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 be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Participants will receive access to the digital health intervention vimida in addition to TAU.
GAIA
Hamburg, Germany
Fatigue symptom severity
Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).
Time frame: 3 months
Depressive symptoms
Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).
Time frame: 3 months
Health-related quality of life
Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).
Time frame: 3 months
Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Time frame: 3 months
Somatic symptoms
Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).
Time frame: 3 months
Anxiety
Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).
Time frame: 3 months
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