Psychosocial InterventionCISNCT05597501
Covid-Intervention-Study
A study testing manual-based group interventions in people with Psychosocial Intervention, run by Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Intervention
- What is being tested?
- manual-based group interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises
Who cannot join
- suicidal tendency
- insufficient knowledge of the German language
- psychotic episode
- no internet-access
Trial locations and contacts
1 site in 1 country.
Thomas Probst, Univ.Prof.Dr. contact
Austria1 site, 1 recruiting
- Recruiting
University of Continuing Education Krems
Krems, 3500
About this study
Official title: 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).
- Conditions
- Psychosocial Intervention
- Being tested
- manual-based group interventions
- Keywords
- manual-based group intervention, short-term intervention, covid-19, crisis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual-based group interventionsBehavioural
weekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis\&logotherapy
| Study group | Role | What they receive |
|---|---|---|
| CBT (cognitiv behavioural-therapy)-based | Active comparator | weekly psychosocial group-intervention (8 weeks) based on a CBT-manual Receives: Behavioral: manual-based group interventions |
| integrative therapy | Active comparator | weekly psychosocial group-intervention (8 weeks) based on a integrative therapy manual Receives: 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 Receives: Behavioral: manual-based group interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Mental Health Scale (PMH)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Secondary outcomes (6)
WHO-Five Well-Being Index (WHO-5)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Patient Health Questionnaire-9 (PHQ-9)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Generalized Anxiety Disorder Scale-7 (GAD-7)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Somatic Symptome Scale-8 (SSS-8)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Stress Coping Inventars (SCI)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Pereived Stress Scale (PSS)
Measured: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Dinhof, Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems
- Investigators
- Thomas Probst, Univ.Prof.Dr, Principal investigator, University of Continuing Education KremsCarina Dinhof, MSc., Principal investigator, University of Continuing Education KremsRafael Rabenstein, MBA, MSc., Principal investigator, University of Continuing Education Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597501
- Sponsor's protocol ID
- 21/2021-2024
- Acronym
- CIS
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual-based Psychosocial Group Interventions for Coping With the Covid-19 Pandemic and Other Crises
- ClinicalTrials.gov ID
- NCT05597501
- Acronym / sponsor ID
- CIS / 21/2021-2024
- Conditions
- Psychosocial Intervention
- Keywords
- manual-based group intervention, short-term intervention, covid-19, crisis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education KremsUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT (cognitiv behavioural-therapy)-based | Active comparator | Behavioral: manual-based group interventionsweekly psychosocial group-intervention (8 weeks) based on a CBT-manual |
| integrative therapy | Active comparator | Behavioral: manual-based group interventionsweekly psychosocial group-intervention (8 weeks) based on a integrative therapy manual |
| Existential Analysis and Logotherapy | Active comparator | Behavioral: manual-based group interventionsweekly psychosocial group-intervention (8 weeks) based on a Existential Analysis and Logotherapy manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises
Key exclusion criteria (4 listed)
- suicidal tendency
- insufficient knowledge of the German language
- psychotic episode
- no internet-access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual-based group interventionsweekly group interventions (90min) following manuals of either CBT, integrative therapy or existential analysis\&logotherapy | Behavioural | CBT (cognitiv behavioural-therapy)-based, Existential Analysis and Logotherapy, integrative therapy |
Primary outcome
Positive Mental Health Scale (PMH)
Time frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up
6 secondary outcomes
WHO-Five Well-Being Index (WHO-5)
Time frame: 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
Generalized Anxiety Disorder Scale-7 (GAD-7)
Time frame: 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
Stress Coping Inventars (SCI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Probst, Univ.Prof.Dr. contact
Thomas Probst, Univ.Prof.Dr principal investigator
University of Continuing Education Krems
Carina Dinhof, MSc. principal investigator
University of Continuing Education Krems
Rafael Rabenstein, MBA, MSc. principal investigator
University of Continuing Education Krems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual-based group interventions in people with Psychosocial Intervention, run by Department for Psychosomatic Medicine and Psychotherapy, University for Continuing Education Krems at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carina Dinhof, MSc. (+43 2732 893 ext. 5493, cis@donau-uni.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Mental Health Scale (PMH) (time frame: Screening - Start Intervention - after 8 weeks intervention - 4 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.