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Completed

NCT Number: NCT06726772

Group Psychotherapy in Long COVID

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Psychotherapy

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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