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Trial record 26 of 674 for:    applied AND web-

Evaluation of a Web Application That Supports Behavior Change in Work Related Stress

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ClinicalTrials.gov Identifier: NCT03077568
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mälardalen University

Brief Summary:

A randomized controlled trial is needed to strengthen the evidence in the area of web-based self-management programs for stress-reduction.

Aim The aim for the study is to compare the effects of the web-application that supports behavior change in stress-management to a waiting list group in persons with perceived stress.

Method This study will have the design of a randomized controlled trial (RCT). The CONSORT guidelines will be used for reporting the study.

Sample: Different sectors in the region will be included. Three different high-schools in Västerås City, social services authority in Västerås municipality, a large private company in the region, three different clinics within the county council and the municipality of Köping have signed the attestation of participation.

Intervention: The intervention is the program for web-based stress self-management My Stress Control.

Procedure: After informed consent the participants will, during approximately 2-4 months by their own go through the web-based program for stress self-management. The waiting-list group will also get access to My Stress Control after post-measurements.

Data-analysis: Descriptive statistics will be used for demographic data. Missing data will be replaced as recommended for the different measurements included, commonly by using the mean for responded items within the sub scale. Inferential analyses will be conducted by using multivariate statistical analysis.

Drop-out analysis will be conducted by comparing pre-interventions measures for those who completed the program with those who did not.


Condition or disease Intervention/treatment Phase
Psychologic Stress Occupation-Related Stress Disorder Health Behavior Behavioral: My Stress Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Web Application That Supports Behavior Change in Work Related Stress - a Randomized Controlled Trial
Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: My Stress Control
This group gets access to the web-based program for stress-management. They will, by their own, go through the automated program. Measurements are conducted before, after as well as 3 months after the intervention.
Behavioral: My Stress Control

The web-based program is designed to educate the users in how stress can affect their health, provide tools to handle stress and also educate the users in a problem-solving method to prevent and manage stress-related problems in the future.

The program is tailored for each user. The stress-management techniques included are: assertiveness training, change negative thinking, pleasant activity scheduling, relaxation, time-management, stimulus control and sleep restriction to improve sleep and physical activity.

Central techniques to support behaivor change in My Stress Controll are encourage intention formulation, specific goal-setting, feedback on performance and reevaluation of goals.


No Intervention: Wait-list group
The wait-list grop will complete the same measures as the intervention group completes before and after the intervention with similar time spread. The wait-list group will then get access to the web-based program.



Primary Outcome Measures :
  1. Change in perceive stress measured with Perceived Stress Scale -14 [ Time Frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention ]
    Wait-list group will conduct the same measures for their corresponding "pre" and "post" measures for an estimated timeframe of 2 months.


Secondary Outcome Measures :
  1. Motivation for Change Questionnaire [ Time Frame: Before intervention. ]
    Wait-list will complete this measure for their corresponding "pre"-measure

  2. Change in self-efficacy believes for coping measured with Coping Self-Efficacy Scale [ Time Frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention ]
    Wait-list group will conduct the same measures for their corresponding "pre" and "post" measures for an estimated timeframe of 2 months.

  3. Change in perception of psychosocial factors at work measured with QPS Nordic-34+ for psychosocial factors at work [ Time Frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention ]
    As Coping Self-Efficacy Scale

  4. Change in work engagement measured with Utrecht work engagement Scale [ Time Frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention ]
    As Coping Self-Efficacy Scale

  5. Change in coping behaviors measured with Brief COPE Questionnaire [ Time Frame: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention ]
    As Coping Self-Efficacy Scale



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Score 17 or more on Perceived Stress Scale -14
  • Able to read and speak Swedish
  • Employed
  • Consent to take part in the study

Exclusion Criteria:

  • Scoring 11 or more on either of sub scales of Hospital Anxiety and Depression Scale
  • Currently on sick leave caused by stress, anxiety or depression

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): NCT03077568


Locations
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Sweden
School of Health, Care and Social Welfare; Mälardalen University
Västerås, Västmanland, Sweden, 72123
Sponsors and Collaborators
Mälardalen University
Investigators
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Principal Investigator: Anne Söderlund, PhD Mälardalen University, Sweden

Publications:
Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal and coping. New York, NY, US: Springer.
Madden, T. J., Ellen, P. S., & Ajzen, I. (1992). A Comparison of the Theory of Planned Behavior and the Theory of Reasoned Action. Personality and Social Psychology Bulletin, 18(1), 3-9.
Ponce, A. N., Lorber, W., Paul, J. J., Esterlis, I., Barzvi, A., Allen, G. J., & Pescatello, L. S. (2008). Comparisons of Varying Dosages of Relaxation in a Corporate Setting: Effects on Stress Reduction. International Journal of Stress Management, 15(4), 396-407.
Welbourne, J. L., Eggerth, D., Hartley, T. A., Andrew, M. E., & Sanches, F. (2007). Coping strategies in the workplace: Relationships with attributional style and job satisfaction. . Journal of Vocational Behavior, 70(2), 312-325. doi:10.1016/j.jvb.2006.10.006

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Responsible Party: Mälardalen University
ClinicalTrials.gov Identifier: NCT03077568     History of Changes
Other Study ID Numbers: 2015/0646
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

Keywords provided by Mälardalen University:
internet
web-based
behavior change
stress-management

Additional relevant MeSH terms:
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Occupational Stress
Stress, Psychological
Occupational Diseases
Behavioral Symptoms