Clinical trial NCT06726772: Group Psychotherapy in Long COVID
Official title: Post-COVID-19 Symptom Burden: Effects of an Outpatient Group Psychotherapy in Long COVID Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of Fatigue Score measured with the Questionnaire "FSS" (Fatigue Severity Scale) from baseline to 8 weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change of Insomnia Score measured with the Questionnaire "ISI" (Insomnia Severity Index) from baseline to 8 weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 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
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change of Depression and Anxiety Score measured with the Questionnaire "HADS" (Hospital Anxiety and Depression Scale) from baseline to 8 weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change of Depression, Anxiety, and Somatic Symptom Scores measured with the Questionnaire "PHQ-SADS" (Patient Health Questionnaire) from baseline to 8 weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Change of Psychotraumatology Score measured with the Questionnaire "IES-R" (Impact of Event Scale-revised) from baseline to 8 weeks
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sankt Gallen
country: Switzerland
facility: Department of Psychosomatic Medicine and Consultation-Liaison Psychiatry, Cantonal Hospital St.Gallen, Switzerland
Study officials:
References: