Group Psychotherapy in Long COVID

NCT06726772 | Completed

• 1 other identifier: PSOMA-2022-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to establish a single-arm group psychotherapy and to evaluate its clinical effectiveness in long COVID patients.

Conditions

Long COVID; COVID-19

Keywords

COVID-19; Long COVID; Long COVID-19 Syndrome; Group Psychotherapy; Cognitive Behavioral Therapy; CBT; Acceptance and Commitment Therapy; ACT; Psychometrics

Outcome Measures

Primary Outcomes (6)

• Change of Fatigue Score measured with the Questionnaire "FSS" (Fatigue Severity Scale) from baseline to 8 weeks

  9 is equivalent to no fatigue and 63 indicates the worst possible fatigue.

  From enrollment to the end of treatment at 8 weeks

• Change of Insomnia Score measured with the Questionnaire "ISI" (Insomnia Severity Index) from baseline to 8 weeks

  0 is equivalent to no insomnia and 28 indicates the worst possible insomnia.

  From enrollment to the end of treatment at 8 weeks

• Change of Quality of Life and Current Health Status measured with the Questionnaire "EQ-5D-5L" (European Quality of Life 5 Dimensions 5 Level Version) from baseline to 8 weeks

  0 (and -0.59) is equivalent to the lowest quality of life (and current health) and 100 (and 1) indicates the best possible quality of life (and current health)

  From enrollment to the end of treatment at 8 weeks

• Change of Depression and Anxiety Score measured with the Questionnaire "HADS" (Hospital Anxiety and Depression Scale) from baseline to 8 weeks

  0 is equivalent to no depression/anxiety and 21 indicates the worst possible depression/anxiety.

  From enrollment to the end of treatment at 8 weeks

• Change of Depression, Anxiety, and Somatic Symptom Scores measured with the Questionnaire "PHQ-SADS" (Patient Health Questionnaire) from baseline to 8 weeks

  0 is equivalent to no depression/anxiety/somatic symptoms and 30 indicates the worst possible depression/anxiety/somatic symptoms.

  From enrollment to the end of treatment at 8 weeks

• Change of Psychotraumatology Score measured with the Questionnaire "IES-R" (Impact of Event Scale-revised) from baseline to 8 weeks

  -4.36 is equivalent to no psychotraumatology (no suspected PTSD) and 2.99 indicates the worst possible psychotraumatology (suspected PTSD). A score equally or greater than zero (cut-off point) indicates suspected PTSD.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Intervention (Group Psychotherapy)

EXPERIMENTAL

Behavioral: Group Psychotherapy

Interventions

Group Psychotherapy BEHAVIORAL

Group psychotherapy based on Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) elements

Intervention (Group Psychotherapy)

Eligibility Criteria

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

You may qualify if:

• Signed general consent form of the Cantonal Hospital of St.Gallen
• Adult patients (≥ 18 years of age)
• Long COVID diagnosis made as part of the long COVID consultation at the Cantonal Hospital of St.Gallen
• Screening for psychological stress and suitability for group therapy through an initial consultation with a psychotherapeutic specialist from the Department of Psychosomatic Medicine and Consultation-Liaison Psychiatry at the Cantonal Hospital of St.Gallen

You may not qualify if:

• Insufficient language skills for completing the questionnaires in German
• Refusal to sign the general consent form
• Severe mental disorders requiring an individualized setting, i.e. suicidal tendencies at the time of screening, acute psychosis and personality disorder

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Department of Psychosomatic Medicine and Consultation-Liaison Psychiatry, Cantonal Hospital St.Gallen, Switzerland

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Psychologist

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: November 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)