Covid-Intervention-Study (CIS)

October 24, 2022 updated by: Carina Dinhof, Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems

Manual-based Psychosocial Group Interventions for Coping With the Covid-19 Pandemic and Other Crises

The goal of this invention study is test and compare short-term manual-based psychosocial group interventions in die Austrian population suffering from stresses and strains due to the Covid-19 Pandemic and other crises.

The main question it aims to answer: Does short-term manual-based psychosocial group interventions improve the mental well-being of the participants?

Participants will attend weekly a manual-based group (8 weeks) and answer online-questionnaires and surveys (pseudonymized).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

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 Contact

Study Contact Backup

Study Locations

  • Austria
      • Krems an der Donau, Austria, 3500
        • Recruiting
        • University of Continuing Education Krems

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises

Exclusion Criteria:

  • suicidal tendency
  • insufficient knowledge of the German language
  • psychotic episode
  • no internet-access

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT (cognitiv behavioural-therapy)-based
weekly psychosocial group-intervention (8 weeks) based on a CBT-manual
Behavioral: manual-based group interventions
weekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis&logotherapy
Active Comparator: integrative therapy
weekly psychosocial group-intervention (8 weeks) based on a integrative therapy manual
Behavioral: manual-based group interventions
weekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis&logotherapy
Active Comparator: Existential Analysis and Logotherapy
weekly psychosocial group-intervention (8 weeks) based on a Existential Analysis and Logotherapy manual
Behavioral: manual-based group interventions
weekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis&logotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive Mental Health Scale (PMH)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
WHO-Five Well-Being Index (WHO-5)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Somatic Symptome Scale-8 (SSS-8)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Stress Coping Inventars (SCI)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Pereived Stress Scale (PSS)
Time Frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

Collaborators and Investigators

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

Sponsor

Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems

Investigators

  • Principal Investigator: Thomas Probst, Univ.Prof.Dr, University of Continuing Education Krems
  • Principal Investigator: Carina Dinhof, MSc., University of Continuing Education Krems
  • Principal Investigator: Rafael Rabenstein, MBA, MSc., University of Continuing Education Krems

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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21/2021-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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