Long COVID, Post COVID-19 Condition
Conditions
Brief summary
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.
Interventions
BEHAVIORALvimida
Participants will receive access to the digital health intervention vimida in addition to TAU.
Sponsors
Medical School Hamburg
Institut Long-Covid Rostock
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue symptom severity | 3 months | Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 3 months | Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome). |
| Health-related quality of life | 3 months | Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome). |
| Functioning | 3 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). |
| Somatic symptoms | 3 months | Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome). |
| Anxiety | 3 months | Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fatigue symptom severity | 6 months | Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome). |
| Depressive symptoms | 6 months | Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome). |
| Health-related quality of life | 6 months | Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome). |
| Functioning | 6 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). |
| Somatic symptoms | 6 months | Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome). |
| Anxiety | 6 months | Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome). |
Countries
Germany
Outcome results
None listed