Mental Health DisorderStayOKNCT03213327
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
A study testing StayOk web application in people with Mental Health Disorder, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
The validity and the sensitivity of different measures implemented in the web application StayOk are investigated. The measures are used primarily for the assessment and the early identification of psychosocial risks. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- StayOk web application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jul 2017to 31 Jul 2019
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at 16 years of age
- mild to moderate psychological distress
Who cannot join
- serious cognitive impairment due to dementia or cerebrovascular insult
- Insufficient knowledge of one of the following languages: German, French, Italian or English
Trial locations and contacts
1 site in 1 country.
About this study
The validity and the sensitivity of different measures implemented in the web application StayOk are investigated. The measures are used primarily for the assessment and the early identification of psychosocial risks. Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.
- Conditions
- Mental Health Disorder
- Being tested
- StayOk web application
- Keywords
- mental health, assessment, health promotion, case management, health insurance
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StayOk web applicationDevice
Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
| Study group | Role | What they receive |
|---|---|---|
| Case management | Other | Case management program Utilization of the StayOk web application Receives: Device: StayOk web application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis \& Melisaratos, 1983)
Measured: 0 week (first assessment)
Work-related sense of coherence
The work-related sense of coherence is assessed by the Work Sense of Coherence (W-SoC 9; Jenny et al., 2016)
Measured: 0 weeks
Perceived self-efficacy
This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)
Measured: 0 weeks
Secondary outcomes (1)
Effectiveness of health-promoting advices
The effectiveness of the advices generated by the software is assessed by means of a self-developed questionnaire: Participants are inquired as to (1) whether they put in practice the advices and (2) how they evaluate the benefit of the applied advices and the consequent satisfaction.
Measured: 12 weeks after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start10 Jul 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients are examined at two time points: baseline and 12 weeks after the Intervention. The Intervention consists of health-promoting advices provided by the software algorithm. The effect of this intervention is evaluated 12 weeks after.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Services, Helsana, Neomentum, Sanatorium Kilchberg AG, Design your life
- Responsible party
- Principal investigator, Aureliano Crameri, Zurich University of Applied Sciences
- Investigators
- Agnes von Wyl, Prof, Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213327
- Sponsor's protocol ID
- BASEC-Nr. 2016-00879
- Acronym
- StayOK
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2017
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
PubMed 6622612Jenny GJ, Bauer GF, Vinje HF, Vogt K, Torp S. The Application of Salutogenesis to Work. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK435821/
PubMed 28590629Damasio BF, Valentini F, Nunes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brahler E, Finck C, Zenger M. Is the General Self-Efficacy Scale a Reliable Measure to be used in Cross-Cultural Studies? Results from Brazil, Germany and Colombia. Span J Psychol. 2016 May 26;19:E29. doi: 10.1017/sjp.2016.30.
PubMed 27225231
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
- ClinicalTrials.gov ID
- NCT03213327
- Acronym / sponsor ID
- StayOK / BASEC-Nr. 2016-00879
- Conditions
- Mental Health Disorder
- Keywords
- mental health, assessment, health promotion, case management, health insurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Health and Medical Services, Helsana, Neomentum, Sanatorium Kilchberg AG, Design your life
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Jul 2017 (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 validity and the sensitivity of different measures implemented in the web application StayOk are investigated. The measures are used primarily for the assessment and the early identification of psychosocial risks. Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are examined at two time points: baseline and 12 weeks after the Intervention. The Intervention consists of health-promoting advices provided by the software algorithm. The effect of this intervention is evaluated 12 weeks after.
| Arm | Type | Receives |
|---|---|---|
| Case management | Other | Device: StayOk web applicationCase management program Utilization of the StayOk web application |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- at 16 years of age
- mild to moderate psychological distress
Key exclusion criteria (2 listed)
- serious cognitive impairment due to dementia or cerebrovascular insult
- Insufficient knowledge of one of the following languages: German, French, Italian or English
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 |
|---|---|---|
| StayOk web applicationPatients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices | Device | Case management |
Primary outcome
Psychological distress
Time frame: 0 week (first assessment)
The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis \& Melisaratos, 1983)
Work-related sense of coherence
Time frame: 0 weeks
The work-related sense of coherence is assessed by the Work Sense of Coherence (W-SoC 9; Jenny et al., 2016)
Perceived self-efficacy
Time frame: 0 weeks
This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)
1 secondary outcome
Effectiveness of health-promoting advices
Time frame: 12 weeks after the first assessment
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 23 Jun 2020.
- Background: PubMed 6622612Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
- Background: PubMed 28590629Jenny GJ, Bauer GF, Vinje HF, Vogt K, Torp S. The Application of Salutogenesis to Work. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK435821/
- Background: PubMed 27225231Damasio BF, Valentini F, Nunes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brahler E, Finck C, Zenger M. Is the General Self-Efficacy Scale a Reliable Measure to be used in Cross-Cultural Studies? Results from Brazil, Germany and Colombia. Span J Psychol. 2016 May 26;19:E29. doi: 10.1017/sjp.2016.30.
- Stay OKLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mental Health Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Agnes von Wyl, Prof principal investigator
Zurich University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StayOk web application in people with Mental Health Disorder, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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 2 inclusion and 2 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 23 Jun 2020. 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 Switzerland. 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?
Psychological distress (time frame: 0 week (first assessment)). The study lists 3 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 NCT03213327, which also lists 3 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 23 Jun 2020.