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StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks (StayOK)

Primary Purpose

Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
StayOk web application
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Disorder focused on measuring mental health, assessment, health promotion, case management, health insurance

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • at 16 years of age
  • mild to moderate psychological distress

Exclusion Criteria:

  • serious cognitive impairment due to dementia or cerebrovascular insult
  • Insufficient knowledge of one of the following languages: German, French, Italian or English

Sites / Locations

  • Helsana

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Case management

Arm Description

Case management program Utilization of the StayOk web application

Outcomes

Primary Outcome Measures

Psychological distress
The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983)
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)
Perceived self-efficacy
This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)

Secondary Outcome Measures

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.

Full Information

First Posted
June 15, 2017
Last Updated
June 21, 2020
Sponsor
Zurich University of Applied Sciences
Collaborators
Health and Medical Services, Helsana, Neomentum, Sanatorium Kilchberg AG, Design your life
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1. Study Identification

Unique Protocol Identification Number
NCT03213327
Brief Title
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Acronym
StayOK
Official Title
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences
Collaborators
Health and Medical Services, Helsana, Neomentum, Sanatorium Kilchberg AG, Design your life

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder
Keywords
mental health, assessment, health promotion, case management, health insurance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case management
Arm Type
Other
Arm Description
Case management program Utilization of the StayOk web application
Intervention Type
Device
Intervention Name(s)
StayOk web application
Intervention Description
Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
Primary Outcome Measure Information:
Title
Psychological distress
Description
The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983)
Time Frame
0 week (first assessment)
Title
Work-related sense of coherence
Description
The work-related sense of coherence is assessed by the Work Sense of Coherence (W-SoC 9; Jenny et al., 2016)
Time Frame
0 weeks
Title
Perceived self-efficacy
Description
This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)
Time Frame
0 weeks
Secondary Outcome Measure Information:
Title
Effectiveness of health-promoting advices
Description
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.
Time Frame
12 weeks after the first assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at 16 years of age mild to moderate psychological distress Exclusion Criteria: serious cognitive impairment due to dementia or cerebrovascular insult Insufficient knowledge of one of the following languages: German, French, Italian or English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes von Wyl, Prof
Organizational Affiliation
Zurich University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsana
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6622612
Citation
Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
Results Reference
background
PubMed Identifier
28590629
Citation
Jenny 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/
Results Reference
background
PubMed Identifier
27225231
Citation
Damasio 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.
Results Reference
background
Links:
URL
https://www.zhaw.ch/en/psychology/research/clinical-psychology-and-health-psychology/prevention-and-health-promotion/stay-ok/
Description
Stay OK

Learn more about this trial

StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks

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