Long COVID: psychological risk factors and their modification

Psychological risk factors for persistent somatic symptoms in Long COVID and their modification: a 3-arm randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15068418

Enrollment

258

Registered

2023-01-17

Start date

2023-10-09

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent somatic symptoms in patients with Long COVID Infections and Infestations

Interventions

We will use a three-arm randomised-controlled trial (RCT) design. A fixed randomization schedule, stratified by gender, will be programmed and conducted electronically. Experimental intervention 1 (C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 24/08/2023: 1. SARS-CoV-2 infection and Long COVID measured using single items at baseline, after 6 weeks, 3 months, and 6 months 2. Long COVID symptoms measured using a self-developed screening questionnaire on Long COVID as well as other post-infectious symptoms called PHQ-15 PAIS at baseline, after 6 weeks, 3 months, and 6 months 3. Fatigue measured using the Fatigue Scale (FS) at baseline, after 6 weeks, 3 months, and 6 months 4. Post-exertional malaise measured using the DePaul Symptom Questionnaire Post-Exertional Malaise (DSQ-PEM) at baseline, after 6 weeks, 3 months, and 6 months 5. Pain measured using the Pain Disability Index – adapted (PDI) at baseline, after 6 weeks, 3 months, and 6 months 6. Risk factors for somatic symptom persistence measured using joint core instruments of RU5211 SOMACROSS at baseline, after 6 weeks, 3 months, and 6 months 7. Somatic Symptom Disorder according to DSM-5 measured by conducting a structured clinical interview (SCID) at baseline and after 3 months 8. Illness-related anxiety measured using the Somatic Symptom Disorder – B Criteria Scale (SSD-12) at baseline, after 6 weeks, 3 months, and 6 months 9. Treatment expectations measured using the Treatment Expectation Questionnaire (TEX-Q) at baseline, after 6 weeks, 3 months, and 6 months 10. Expectations of symptom severity measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months 11. Expectations of symptom burden measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months 12. Expectations of coping with symptoms measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months Previous secondary outcome measures: 1. Fatigue measured using the Modified Fatigue Impact Scale-5 item version (MFIS-5) at baseline, after 6 weeks, 3 months, and 6 months 2. Shortness of breath measured using a Numeric Rating Scale (NRS) at baseline, after 6 we	—

Measure

Time frame

Current secondary outcome measures as of 24/08/2023: 1. SARS-CoV-2 infection and Long COVID measured using single items at baseline, after 6 weeks, 3 months, and 6 months 2. Long COVID symptoms measured using a self-developed screening questionnaire on Long COVID as well as other post-infectious symptoms called PHQ-15 PAIS at baseline, after 6 weeks, 3 months, and 6 months 3. Fatigue measured using the Fatigue Scale (FS) at baseline, after 6 weeks, 3 months, and 6 months 4. Post-exertional malaise measured using the DePaul Symptom Questionnaire Post-Exertional Malaise (DSQ-PEM) at baseline, after 6 weeks, 3 months, and 6 months 5. Pain measured using the Pain Disability Index – adapted (PDI) at baseline, after 6 weeks, 3 months, and 6 months 6. Risk factors for somatic symptom persistence measured using joint core instruments of RU5211 SOMACROSS at baseline, after 6 weeks, 3 months, and 6 months 7. Somatic Symptom Disorder according to DSM-5 measured by conducting a structured clinical interview (SCID) at baseline and after 3 months 8. Illness-related anxiety measured using the Somatic Symptom Disorder – B Criteria Scale (SSD-12) at baseline, after 6 weeks, 3 months, and 6 months 9. Treatment expectations measured using the Treatment Expectation Questionnaire (TEX-Q) at baseline, after 6 weeks, 3 months, and 6 months 10. Expectations of symptom severity measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months 11. Expectations of symptom burden measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months 12. Expectations of coping with symptoms measured using a Numeric Rating Scale (NRS) at baseline, after 6 weeks, 3 months, and 6 months Previous secondary outcome measures: 1. Fatigue measured using the Modified Fatigue Impact Scale-5 item version (MFIS-5) at baseline, after 6 weeks, 3 months, and 6 months 2. Shortness of breath measured using a Numeric Rating Scale (NRS) at baseline, after 6 we

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026