Investigating the Effectiveness of Vimida

NCT06251518 | Active Not Recruiting

• 1 other identifier: vimida RCT 2024
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; Post COVID-19 Condition

Outcome Measures

Primary Outcomes (1)

• Fatigue symptom severity

  Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).

  3 months

Secondary Outcomes (5)

• Depressive symptoms

  3 months

• Health-related quality of life

  3 months

• Functioning

  3 months

• Somatic symptoms

  3 months

• Anxiety

  3 months

Other Outcomes (6)

• Fatigue symptom severity

  6 months

• Depressive symptoms

  6 months

• Health-related quality of life

  6 months

Study Arms (2)

vimida + TAU

EXPERIMENTAL

Participants allocated to the intervention group will receive access to vimida in addition to treatment as usual (TAU). vimida is a digital health application designed for individuals with post-Covid conditions who suffer from fatigue, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by vimida are psychoeducation, activity and recovery, attention, stress management, sleep management, cognitive restructuring, and social resources. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.

Behavioral: vimida

TAU

NO INTERVENTION

Participants allocated to the control group will receive access to treatment as usual (TAU).

Interventions

vimida BEHAVIORAL

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

vimida + TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaia AG: lead
• Medical School Hamburg: collaborator
• Institut Long-Covid Rostock: collaborator

Study Sites (1)

GAIA

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johanna Schröder, PhD

  Medical School Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 9, 2024
• Study Start: February 13, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)