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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03213327
Other study ID # BASEC-Nr. 2016-00879
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2017
Est. completion date July 31, 2019

Study information

Verified date June 2020
Source Zurich University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Completed
Enrollment 174
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
StayOk web application
Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices

Locations

Country Name City State
Switzerland Helsana Zürich

Sponsors (6)

Lead Sponsor Collaborator
Zurich University of Applied Sciences Design your life, Health and Medical Services, Helsana, Neomentum, Sanatorium Kilchberg AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Damásio BF, Valentini F, Núñes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brähler 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. — View Citation

Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605. — View 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, Lindström 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/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychological distress The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983) 0 week (first assessment)
Primary 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) 0 weeks
Primary Perceived self-efficacy This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016) 0 weeks
Secondary 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. 12 weeks after the first assessment
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