Group Psychotherapy in Long COVID

February 14, 2025 updated by: Katja Haemmerli Keller, Cantonal Hospital of St. Gallen

Post-COVID-19 Symptom Burden: Effects of an Outpatient Group Psychotherapy in Long COVID Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study took place at the Cantonal Hospital St.Gallen, a tertiary care hospital in Eastern Switzerland, and included data collection between November 2021 and January 2024. During this time span, the same licensed psychotherapist conducted the group psychotherapy six times in total with a maximum of nine patients each. Each of the six groups had one-hour group therapy sessions weekly within eight consecutive weeks. During the study period, the group psychotherapy was part of a more comprehensive treatment for long COVID as all patients primarily received active pacing therapy.

The investigators implemented cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT) elements into group psychotherapy and focused on fatigue, insomnia, depression, anxiety, somatic symptoms, psychotraumatology, and quality of life as psychosomatic outcome measures (pre- and post-interventional).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Department of Psychosomatic Medicine and Consultation-Liaison Psychiatry, Cantonal Hospital St.Gallen, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (Group Psychotherapy)
Behavioral: Group Psychotherapy
Group psychotherapy based on Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Fatigue Score measured with the Questionnaire "FSS" (Fatigue Severity Scale) from baseline to 8 weeks
Time Frame: From enrollment to the end of treatment at 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
Time Frame: From enrollment to the end of treatment at 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
Time Frame: From enrollment to the end of treatment at 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
Time Frame: From enrollment to the end of treatment at 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
Time Frame: From enrollment to the end of treatment at 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
Time Frame: From enrollment to the end of treatment at 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSOMA-2022-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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