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

Primary Purpose

Psychologic Stress, Occupation-Related Stress Disorder, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
My Stress Control
Sponsored by
Mälardalen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychologic Stress focused on measuring internet, web-based, behavior change, stress-management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Health, Care and Social Welfare; Mälardalen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

My Stress Control

Wait-list group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in perceive stress measured with Perceived Stress Scale -14
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

Motivation for Change Questionnaire
Wait-list will complete this measure for their corresponding "pre"-measure
Change in self-efficacy believes for coping measured with Coping Self-Efficacy Scale
Wait-list group will conduct the same measures for their corresponding "pre" and "post" measures for an estimated timeframe of 2 months.
Change in perception of psychosocial factors at work measured with QPS Nordic-34+ for psychosocial factors at work
As Coping Self-Efficacy Scale
Change in work engagement measured with Utrecht work engagement Scale
As Coping Self-Efficacy Scale
Change in coping behaviors measured with Brief COPE Questionnaire
As Coping Self-Efficacy Scale

Full Information

First Posted
December 7, 2016
Last Updated
March 20, 2018
Sponsor
Mälardalen University
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1. Study Identification

Unique Protocol Identification Number
NCT03077568
Brief Title
Evaluation of a Web Application That Supports Behavior Change in Work Related Stress
Official Title
Evaluation of a Web Application That Supports Behavior Change in Work Related Stress - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mälardalen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A randomized controlled trial is needed to strengthen the evidence in the area of web-based self-management programs for stress-reduction. The program to be evaluated is named My Stress Control, and 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. My Stress Control is a self-administered and fully automated web-application. Aim The aim for the study is to compare the effect 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. Power: Power has been calculated by using a study comparing acceptance and commitment therapy with a wait-list group with the primary outcome stress, measured with PSS-14 (Cohen, Kamark, & Mermelstein, 1983). More specifically the power was calculated by using the scores of a group who reported lower stress-levels than 25 on PSS-14 (Brinkborg, Michaneck, Hessel, & Berglund, 2011). The calculation has been adjusted for both between-group comparison as well as for within-group comparison. An estimated effect size of .40 with power equal to .80 and a significance level of 0.05, gives an estimated population size of 98 individuals in each group. With an estimated dropout rate of 20% the population needed in each group is 118 persons. Randomization: Since the included worksites are different to its kind, and to number of employees, randomization will be done by quotation with a 6-person block randomization. The block randomization will make the sample percentage similar to the included worksites. Intervention: The intervention is the program for web-based stress self-management My Stress Control. My Stress Control starts with screening for stress levels according to Perceived Stress Scale (PSS) (Cohen et al., 1983), with a cut of score of 17 (Brinkborg et al., 2011) for accessing the program. To avoid to include users with more extended problems with anxiety and depression, a screening is done with Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983). Users scoring 11 or higher on either of the two subscales are recommended to seek support from traditional healthcare. The security of the web-application is high and all information is encrypted. IP addresses who tries to log in without access are banned after a certain number of trials. The more secure https is used instead of the less secure http. All requests towards the server will be logged and all stored data have backup being done continuously. Considering the theoretical framework of the self-management program there are several useful health psychological theories. Regarding behavior change in stress context three theories arise as more important; The Transactional Theory of Stress and Coping (TTC) (Lazarus & Folkman, 1984), Social Cognitive Theory (SCT) (Bandura, 1989), The Transtheoretical Model (TTM) and the Theory of Stages of Change (SoC) (Evers et al., 2006), and the Theory of Reasoned Action and the Theory of Planned Behavior(Madden, Ellen, & Ajzen, 1992). The theories play a crucial role in tailoring and assessing stress. Studies show that web-based programs using these theories are more successful than other web-based programs for behavior change (Webb, Joseph, Yardley, & Michie, 2010). The program is sensitive to how the user formulates a guided functional behavior analysis that also tailors the program by recommending possible preferable stress-management techniques for each user. These stress-management techniques are specific behavior change techniques to support the user in situations where they experience stress or to prevent and handle consequences of stress. The user has the opportunity to take part of all stress-management techniques included. The stress-management techniques included are: assertiveness training (Imamura et al., 2014), cognitive restructuring (Welbourne, Eggerth, Hartley, Andrew, & Sanches, 2007), pleasant activity scheduling (Mazzucchelli, Kane, & Rees, 2010), relaxation (Ponce et al., 2008), time-management (Häfner & Stock, 2010), stimulus control and sleep restriction to improve sleep (Thiart, Lehr, Ebert, Berking, & Riper, 2015) and physical activity (Lindegård, Jonsdottir, Börjesson, Lindwall, & Gerber, 2015). All techniques have shown to be effective in stress-management both in traditional face-to-face therapy and delivered in applications or on the web. Few programs have combined several techniques, and most programs use only one technique. No program combining all techniques included in My Stress Control has been found. The most commonly used behavior modification techniques found in a meta-analysis of changing health behaviors via the Internet were to provide information about the consequences of the behavior, self-monitoring of behavior and identification of barriers and facilitators for behavior(Evers, Prochaska, Driskell, Cummins, & Velicer, 2003). In another study it is also stated that treatment that includes self-monitoring of the behavior and at least one of the following five behavioral change methods has been shown more effective than behavior modification treatment without these techniques; encourage intention formulation, specific goal-setting, feedback on performance and reevaluation of goals (Michie, Abraham, Whittington, McAteer, & Gupta, 2009). These techniques are central in the stress-management program. These behavior modification techniques are more general techniques for behavior change than the specific behavior change techniques for stress-management, and are used in several parts of My Stress Control. They are for example used to support the user to handle the specific techniques for stress management mentioned above. For example: Goal setting and self-monitoring is used as assignments in all the stress-management techniques in My Stress Control. Thus, by using the web-based, self-management program My Stress Control, the individuals are supposed to receive support to develop skills to better cope with their work related stress. 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. Reminders to send in the questionnaires will be sent out two weeks for the questionnaires answered before the intervention and two and four weeks after estimated time for the questionnaires answered during and after the intervention. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychologic Stress, Occupation-Related Stress Disorder, Health Behavior
Keywords
internet, web-based, behavior change, stress-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
My Stress Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Stress Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceive stress measured with Perceived Stress Scale -14
Description
Wait-list group will conduct the same measures for their corresponding "pre" and "post" measures for an estimated timeframe of 2 months.
Time Frame
Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Secondary Outcome Measure Information:
Title
Motivation for Change Questionnaire
Description
Wait-list will complete this measure for their corresponding "pre"-measure
Time Frame
Before intervention.
Title
Change in self-efficacy believes for coping measured with Coping Self-Efficacy Scale
Description
Wait-list group will conduct the same measures for their corresponding "pre" and "post" measures for an estimated timeframe of 2 months.
Time Frame
Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Title
Change in perception of psychosocial factors at work measured with QPS Nordic-34+ for psychosocial factors at work
Description
As 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
Title
Change in work engagement measured with Utrecht work engagement Scale
Description
As 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
Title
Change in coping behaviors measured with Brief COPE Questionnaire
Description
As 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Söderlund, PhD
Organizational Affiliation
Mälardalen University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health, Care and Social Welfare; Mälardalen University
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72123
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
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Evaluation of a Web Application That Supports Behavior Change in Work Related Stress

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