ScreeningNCT06621537
Mental Health Burden and Help-seeking Behavior in the Austrian General Population
An observational study of Screening, run by Sigmund Freud PrivatUniversitat at 1 site in Austria.
Trial summary
This study investigates the symptom burden and help-seeking behavior in the Austrian general population. Current research shows that mental health in Austria has significantly worsened since the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening
- How many people
- 2,025 participants
- Where
- 1 siteAustria
- Study dates
- 10 Oct 2024to 28 Oct 2024
- Phase
- Observational
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: representative sample of the Austrian general population according to age, gender, age x gender, region and education level
Who may be able to join
- at least 14 years old
- Internet access
- sufficient German skills
- residence in Austria
Who cannot join
- younger than 14 years old
- no access to the Internet
- lack of German language skills
- residence outside Austria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Burden and Help-seeking Behavior in the Austrian General Population: from Problem to Psychotherapy in Different Population Groups from a Psychotherapy Science Perspective
This study investigates the symptom burden and help-seeking behavior in the Austrian general population. Current research shows that mental health in Austria has significantly worsened since the COVID-19 pandemic. Lockdowns, social isolation, and uncertainty about the future have led to increased psychological stress, which has remained elevated even after restrictions were lifted. Vulnerable groups such as young people and individuals with a migration background were particularly affected, often experiencing additional stressors like language barriers, cultural differences, and financial strain. Migrant families frequently face more barriers to accessing mental health services, such as linguistic obstacles, lack of knowledge about the healthcare system, insufficient financial resources, stigmatization of mental illness, and cultural differences in understanding mental health. Research shows that migrants are less likely to seek professional help, instead relying on informal networks or alternative healing methods, leaving many untreated.
Therefore, this study aims to further explore these barriers and the differences in help-seeking behavior between individuals with and without migration backgrounds. A representative sample of the Austrian general population will complete validated questionnaires to assess symptom burden, help-seeking behavior, and self-stigmatization. The study findings will help identify obstacles to accessing psychotherapeutic care and provide insight into improving mental health services, particularly for vulnerable groups.
Read the detailed description
The research project focuses on the mental health and help-seeking behaviors of the Austrian general population, with a particular interest in vulnerable groups like individuals with migration backgrounds.
The study employs a comprehensive approach by using an online survey targeting a representative sample of the Austrian general population. Key areas of focus include the symptom burden related to psychological disorders and help-seeking behaviors. The survey incorporates a range of standardised validated measurement tools, including: CORE-OM (to assess psychological well-being, symptoms, functionality, and risks), GHSQ (to evaluate help-seeking behavior), SSOSH (to measure self-stigmatization), PHQ-9 (to assess depressive symptoms), GAD-7 (to measure generalized anxiety disorder), ISI-7 (for insomnia severity), PSS-4 (for stress), CAGE (for alcohol misuse), SOEP (for loneliness), and open questions on stressors and resources.
This study will provide insights into the mental health challenges faced by the general population and identify specific barriers to accessing psychotherapeutic care among people with migration backgrounds. These findings will inform future interventions and support mechanisms for these groups. The recruitment process will involve a professional survey agency (Marketagent GmbH), which will ensure a representative sample, including participants aged 14 and above. Participants must have adequate German language skills and reside in Austria. The results will contribute to improving mental health services and addressing disparities in care access.
- Conditions
- Screening
- Keywords
- general population, Austria, help-seeking behavior, symptom burden
- Medical subject headings
- Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Representative Sample of the Austrian General Population | Sample of the Austriang General Population aged >=14 years representative for age, gender, age x gender, region, education |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Help Seeking Behavior
The General Help-Seeking Questionnaire (GHSQ) is a valdiated standardized tool to assess current intentions to seek help from different sources for different problems. The total score ranges from 10 to 70, with higher scores indicating a greater intention to seek help.
Measured: Once in October 2024
Clincial Outcomes in Routine Evaluation
The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a common self-report measure of global distress with 34 items all answered on the same five level Likert-type scale asking about the respondents state over the last week. It was originally designed and developed in response to a research funding call from the UK Mental Health Foundation which required that the content must cover domains of well-being (4 items), problems (12 items), functioning (12 items) and risk (6 items). The total score ranges from 0 to 136 (sum of items), with higher scores indicating greater symptom/distress burden. Domain scores range from 0 to 16 (well-being), 0 to 48 (problems and functioning) and 0 to 24 (risk). In addition, means can be calculated by dividing the sum of the items by the number of items in the total score or in the respective domains.
Measured: Once in October 2024
Secondary outcomes (8)
Alcohol Abuse
Symptoms of alcohol abuse will be assessed with a brief screening tool, the so-called CAGE questionnaire.
The acronym stands for 4 yes/no items constituting the screening test:
- Have you ever felt that you ought to Cut down on your drinking?
- Have people Annoyed you by criticizing your drinking?
- Have you ever felt bad or Guilty about your drinking?
- Have you ever had a drink first thing in the morn ing to steady your nerves or to get rid of a hangover (Eye-opener)?
The total score ranges from 0 to 4, with higher scores indicating a greater degree of problem drinking behaviour.
Measured: Once in October 2024
Insomnia Symptoms
Symptoms of sleeping disorders will be assessed with the brief version of the insomnia severity index (ISI-7). The total score ranges from 0 to 28, with higher scores indicating higher levels of sleep problems.
Measured: Once in October 2024
Depressive Symptoms
Symptoms of depression will be assessed with the 9 item version of the Patient Health Questionnaire (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater symptom burden.
Measured: Once in October 2024
Symptoms of Anxiety
Symptoms of anxiety will be assessed with the 7 item version of the general anxiety disorder scale (GAD-7). The total score ranges from 0 to 21, with higher scores indicating greater symptom burden.
Measured: Once in October 2024
Self-stigma
The construct of self-stigma as an important factor in people\'s decisions not to seek (psycho)therapeutic treatment is assessed using the 10-item Self-Stigma of Seeking Help (SSOSH) scale. The total score ranges from 10 to 50, with higher scores indicating higher levels of self-stigma.
Measured: Once in October 2024
Free text questions on resources and burdens
Two free text questions will elaborate on perceived burdens and resources following a previous study in the Austrian general population.
- What is currently bothering you the most?
- What helps you most to cope with your problems at the moment?
Measured: Once in October 2024
Perceived Stress Level
The perceived stress level will be assessed with the short version of the perceived stress scale comprising 4 items (PSS-4). The total score ranges from 0 to 16, with higher scores indicating greater symptom burden.
Measured: Once in October 2024
Loneliness
Perceived social isolation is assessed using the three-item loneliness scale (SOEP). The total score ranges from 0 to 12, with higher scores indicating greater social isolation.
Measured: Once in October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ScreeningStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigmund Freud PrivatUniversitat
- Sponsor type
- University, hospital or other
- Collaborators
- Danube University Krems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621537
- Sponsor's protocol ID
- PTW2024_0926
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilson, C. J., Deane, F. P., Ciarrochi, J., and Rickwood, D. (2005). Measuring Help-Seeking Intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
Vogel, D. L., Wade, N. G., and Haake, S. (2006). Measuring the self-stigma associated with seeking psychological help. Journal of Counseling Psychology, 53(3), 325-337. https://doi.org/10.1037/0022-0167.53.3.325
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Schaffler Y, Gachter A, Dale R, Jesser A, Probst T, Pieh C. Concerns and Support after One Year of COVID-19 in Austria: A Qualitative Study Using Content Analysis with 1505 Participants. Int J Environ Res Public Health. 2021 Aug 3;18(15):8218. doi: 10.3390/ijerph18158218.
PubMed 34360512Reinwarth AC, Ernst M, Krakau L, Brahler E, Beutel ME. Screening for loneliness in representative population samples: Validation of a single-item measure. PLoS One. 2023 Mar 16;18(3):e0279701. doi: 10.1371/journal.pone.0279701. eCollection 2023.
PubMed 36928277Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.
PubMed 33813233Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.
PubMed 11772852Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
PubMed 17716538Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Burden and Help-seeking Behavior in the Austrian General Population: from Problem to Psychotherapy in Different Population Groups from a Psychotherapy Science Perspective
- ClinicalTrials.gov ID
- NCT06621537
- Acronym / sponsor ID
- PTW2024_0926
- Conditions
- Screening
- Keywords
- general population, Austria, help-seeking behavior, symptom burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,025 participants (actual)
- Lead sponsor
- Sigmund Freud PrivatUniversitatUniversity, hospital or other
- Collaborators
- Danube University Krems
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 1 Oct 2024 (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.
This study investigates the symptom burden and help-seeking behavior in the Austrian general population. Current research shows that mental health in Austria has significantly worsened since the COVID-19 pandemic. Lockdowns, social isolation, and uncertainty about the future have led to increased psychological stress, which has remained elevated even after restrictions were lifted. Vulnerable groups such as young people and individuals with a migration background were particularly affected, often experiencing additional stressors like language barriers, cultural differences, and financial strain. Migrant families frequently face more barriers to accessing mental health services, such as linguistic obstacles, lack of knowledge about the healthcare system, insufficient financial resources, stigmatization of mental illness, and cultural differences in understanding mental health. Research shows that migrants are less likely to seek professional help, instead relying on informal networks or alternative healing methods, leaving many untreated.
Therefore, this study aims to further explore these barriers and the differences in help-seeking behavior between individuals with and without migration backgrounds. A representative sample of the Austrian general population will complete validated questionnaires to assess symptom burden, help-seeking behavior, and self-stigmatization. The study findings will help identify obstacles to accessing psychotherapeutic care and provide insight into improving mental health services, particularly for vulnerable groups.
Detailed description
The research project focuses on the mental health and help-seeking behaviors of the Austrian general population, with a particular interest in vulnerable groups like individuals with migration backgrounds.
The study employs a comprehensive approach by using an online survey targeting a representative sample of the Austrian general population. Key areas of focus include the symptom burden related to psychological disorders and help-seeking behaviors. The survey incorporates a range of standardised validated measurement tools, including: CORE-OM (to assess psychological well-being, symptoms, functionality, and risks), GHSQ (to evaluate help-seeking behavior), SSOSH (to measure self-stigmatization), PHQ-9 (to assess depressive symptoms), GAD-7 (to measure generalized anxiety disorder), ISI-7 (for insomnia severity), PSS-4 (for stress), CAGE (for alcohol misuse), SOEP (for loneliness), and open questions on stressors and resources.
This study will provide insights into the mental health challenges faced by the general population and identify specific barriers to accessing psychotherapeutic care among people with migration backgrounds. These findings will inform future interventions and support mechanisms for these groups. The recruitment process will involve a professional survey agency (Marketagent GmbH), which will ensure a representative sample, including participants aged 14 and above. Participants must have adequate German language skills and reside in Austria. The results will contribute to improving mental health services and addressing disparities in care access.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Representative Sample of the Austrian General Population | – | –Sample of the Austriang General Population aged >=14 years representative for age, gender, age x gender, region, education |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- representative sample of the Austrian general population according to age, gender, age x gender, region and education level
Key inclusion criteria (4 listed)
- at least 14 years old
- Internet access
- sufficient German skills
- residence in Austria
Key exclusion criteria (4 listed)
- younger than 14 years old
- no access to the Internet
- lack of German language skills
- residence outside Austria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General Help Seeking Behavior
Time frame: Once in October 2024
The General Help-Seeking Questionnaire (GHSQ) is a valdiated standardized tool to assess current intentions to seek help from different sources for different problems. The total score ranges from 10 to 70, with higher scores indicating a greater intention to seek help.
Clincial Outcomes in Routine Evaluation
Time frame: Once in October 2024
The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a common self-report measure of global distress with 34 items all answered on the same five level Likert-type scale asking about the respondents state over the last week. It was originally designed and developed in response to a research funding call from the UK Mental Health Foundation which required that the content must cover domains of well-being (4 items), problems (12 items), functioning (12 items) and risk (6 items). The total score ranges from 0 to 136 (sum of items), with higher scores indicating greater symptom/distress burden. Domain scores range from 0 to 16 (well-being), 0 to 48 (problems and functioning) and 0 to 24 (risk). In addition, means can be calculated by dividing the sum of the items by the number of items in the total score or in the respective domains.
8 secondary outcomes
Alcohol Abuse
Time frame: Once in October 2024
Insomnia Symptoms
Time frame: Once in October 2024
Depressive Symptoms
Time frame: Once in October 2024
Symptoms of Anxiety
Time frame: Once in October 2024
Self-stigma
Time frame: Once in October 2024
Free text questions on resources and burdens
Time frame: Once in October 2024
Perceived Stress Level
Time frame: Once in October 2024
Loneliness
Time frame: Once in October 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- BackgroundWilson, C. J., Deane, F. P., Ciarrochi, J., and Rickwood, D. (2005). Measuring Help-Seeking Intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
- BackgroundVogel, D. L., Wade, N. G., and Haake, S. (2006). Measuring the self-stigma associated with seeking psychological help. Journal of Counseling Psychology, 53(3), 325-337. https://doi.org/10.1037/0022-0167.53.3.325
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 34360512Schaffler Y, Gachter A, Dale R, Jesser A, Probst T, Pieh C. Concerns and Support after One Year of COVID-19 in Austria: A Qualitative Study Using Content Analysis with 1505 Participants. Int J Environ Res Public Health. 2021 Aug 3;18(15):8218. doi: 10.3390/ijerph18158218.
- Background: PubMed 36928277Reinwarth AC, Ernst M, Krakau L, Brahler E, Beutel ME. Screening for loneliness in representative population samples: Validation of a single-item measure. PLoS One. 2023 Mar 16;18(3):e0279701. doi: 10.1371/journal.pone.0279701. eCollection 2023.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 33813233Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.
- Background: PubMed 11772852Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.
- Background: PubMed 17716538Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening, run by Sigmund Freud PrivatUniversitat 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 4 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: finished, as of the sponsor's last update on 8 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Help Seeking Behavior (time frame: Once in October 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621537, which also lists 10 linked publications.
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 8 Nov 2024.