We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03213327
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Mental Health Disorder Device: StayOk web application

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019
Arms and Interventions

Arm Intervention/treatment
Case management
Case management program Utilization of the StayOk web application
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

Outcome Measures

Primary Outcome Measures :
  1. Psychological distress [ Time Frame: 0 week (first assessment) ]
    The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983)

  2. 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)

  3. Perceived self-efficacy [ Time Frame: 0 weeks ]
    This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)

Secondary Outcome Measures :
  1. Effectiveness of health-promoting advices [ Time Frame: 12 weeks after the first assessment ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213327

Contact: Ursula Büsser, MSc +41 79 957 11 58 ursula.buesser@lcc-consulting.ch

Helsana Recruiting
Zürich, Switzerland
Contact: Ebru Tekol         
Sponsors and Collaborators
Zurich University of Applied Sciences
Sanatorium Kilchberg AG
Design your life
Principal Investigator: Agnes von Wyl, Prof Zurich University of Applied Sciences
More Information

Additional Information:
Responsible Party: Aureliano Crameri, Dr. phil., Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03213327     History of Changes
Other Study ID Numbers: BASEC-Nr. 2016-00879
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aureliano Crameri, Zurich University of Applied Sciences:
mental health
health promotion
case management
health insurance

Additional relevant MeSH terms:
Mental Disorders