ong COVID: psychological risk factors and their modificatio

Not Applicable

• Conditions: Persistent somatic symptoms in patients with Long COVID; Infections and Infestations

• Registration Number: ISRCTN15068418
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37920139/ (added 07/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-17
• Last Update Posted: 20 November 2023
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Current inclusion criteria as of 24/08/2023:
1. Self-reported resolved SARS-CoV-2 infection confirmed by a positive PCR, serology, or rapid antigen test
2. Long COVID according to the NICE/AWMF S1-guidelines
3. At least moderately severe ongoing symptoms (PHQ-15 = 10)
4. Age = 18 years
5. Informed consent

Previous inclusion criteria:
1. Resolved SARS-CoV-2 infection confirmed by a positive PCR or serology test
2. Long COVID according to the NICE/AWMF S1 guidelines
3. At least moderately severe ongoing symptoms (PHQ-15 = 10)
4. Age =18 years old
5. Informed consent

Exclusion Criteria

Current exclusion criteria as of 24/08/2023:
1. Acute SARS-CoV-2 infection
2. Intensive care unit treatment for COVID-19
3. Psychotherapeutic treatment in the past 3 months
4. Necessity of acute emergency treatment
5. Acute suicidality
6. A substance use disorder
7. Acute psychosis
8. Cognitive incapacity to comprehend the study materials
9. Inability to complete outcome measures online
10. Insufficient German language skills

Previous exclusion criteria:
1. Intensive care unit treatment for COVID-19
2. Necessity of acute emergency treatment
3. Acute suicidality
4. Psychotherapeutic treatment in the last 3 months
5. Severe cognitive impairment
6. Inability to complete outcome measures online
7. Insufficient German language skills

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall somatic symptom severity assessed using the Patient Health Questionnaire 15 (PHQ-15) at baseline, after 6 weeks, after 3 months (post-interventional follow-up), and after 6 months