NCT05597501

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 24, 2022

Last Update Submit

October 24, 2022

Conditions

Psychosocial Intervention

Keywords

manual-based group interventionshort-term interventioncovid-19crisis

Outcome Measures

Primary Outcomes (1)

  • Positive Mental Health Scale (PMH)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

Secondary Outcomes (6)

  • WHO-Five Well-Being Index (WHO-5)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

  • Patient Health Questionnaire-9 (PHQ-9)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

  • Generalized Anxiety Disorder Scale-7 (GAD-7)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

  • Somatic Symptome Scale-8 (SSS-8)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

  • Stress Coping Inventars (SCI)

    Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up

  • +1 more secondary outcomes

Study Arms (3)

CBT (cognitiv behavioural-therapy)-based

ACTIVE COMPARATOR

weekly psychosocial group-intervention (8 weeks) based on a CBT-manual

Behavioral: manual-based group interventions

integrative therapy

ACTIVE COMPARATOR

weekly psychosocial group-intervention (8 weeks) based on a integrative therapy manual

Behavioral: manual-based group interventions

Existential Analysis and Logotherapy

ACTIVE COMPARATOR

weekly psychosocial group-intervention (8 weeks) based on a Existential Analysis and Logotherapy manual

Behavioral: manual-based group interventions

Interventions

manual-based group interventionsBEHAVIORAL

weekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis\&logotherapy

CBT (cognitiv behavioural-therapy)-basedExistential Analysis and Logotherapyintegrative therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Continuing Education Krems

Krems, 3500, Austria

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Dinhof, MSc.

CONTACT

+43 2732 893cis@donau-uni.ac.at

Thomas Probst, Univ.Prof.Dr.

CONTACT

cis@donau-uni.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 28, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

November 1, 2024

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)