Psychologic StressNCT03077568
Evaluation of a Web Application That Supports Behavior Change in Work Related Stress
A study of Psychologic Stress and Occupation-Related Stress Disorder, run by Mälardalen University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychologic Stress, Occupation-Related Stress Disorder, Health Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score 17 or more on Perceived Stress Scale -14
- Able to read and speak Swedish
- Employed
- Consent to take part in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
School of Health, Care and Social Welfare; Mälardalen University
Västerås, Västmanland County, 72123
About this study
Official title: Evaluation of a Web Application That Supports Behavior Change in Work Related Stress - a Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- My Stress Control
- Keywords
- internet, web-based, behavior change, stress-management
- Medical subject headings
- Stress, Psychological, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Stress ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| My Stress Control | Experimental | 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. Receives: Behavioral: My Stress Control |
| Wait-list group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Secondary outcomes (5)
Motivation for Change Questionnaire
Wait-list will complete this measure for their corresponding "pre"-measure
Measured: Before intervention.
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.
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Change in perception of psychosocial factors at work measured with QPS Nordic-34+ for psychosocial factors at work
As Coping Self-Efficacy Scale
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Change in work engagement measured with Utrecht work engagement Scale
As Coping Self-Efficacy Scale
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Change in coping behaviors measured with Brief COPE Questionnaire
As Coping Self-Efficacy Scale
Measured: Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startDec 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Psychologic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Söderlund, PhD, Principal investigator, Mälardalen University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077568
- Sponsor's protocol ID
- 2015/0646
- Status last verified
- Mar 2018
- First submitted
- 7 Dec 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Publications
Bandura A. Human agency in social cognitive theory. Am Psychol. 1989 Sep;44(9):1175-84. doi: 10.1037/0003-066x.44.9.1175.
PubMed 2782727Brinkborg H, Michanek J, Hesser H, Berglund G. Acceptance and commitment therapy for the treatment of stress among social workers: a randomized controlled trial. Behav Res Ther. 2011 Jun;49(6-7):389-98. doi: 10.1016/j.brat.2011.03.009. Epub 2011 Apr 5.
PubMed 21513917Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Evers KE, Prochaska JM, Prochaska JO, Driskell MM, Cummins CO, Velicer WF. Strengths and weaknesses of health behavior change programs on the internet. J Health Psychol. 2003 Jan;8(1):63-70. doi: 10.1177/1359105303008001435.
PubMed 22113901Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population- and transtheoretical model-based stress-management intervention. Health Psychol. 2006 Jul;25(4):521-9. doi: 10.1037/0278-6133.25.4.521.
PubMed 16846327Hafner A, Stock A. Time management training and perceived control of time at work. J Psychol. 2010 Sep-Oct;144(5):429-47. doi: 10.1080/00223980.2010.496647.
PubMed 20806849Imamura K, Kawakami N, Furukawa TA, Matsuyama Y, Shimazu A, Umanodan R, Kawakami S, Kasai K. Effects of an Internet-based cognitive behavioral therapy (iCBT) program in Manga format on improving subthreshold depressive symptoms among healthy workers: a randomized controlled trial. PLoS One. 2014 May 20;9(5):e97167. doi: 10.1371/journal.pone.0097167. eCollection 2014.
PubMed 24844530Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal and coping. New York, NY, US: Springer.
Lindegard A, Jonsdottir IH, Borjesson M, Lindwall M, Gerber M. Changes in mental health in compliers and non-compliers with physical activity recommendations in patients with stress-related exhaustion. BMC Psychiatry. 2015 Nov 4;15:272. doi: 10.1186/s12888-015-0642-3.
PubMed 26530329Madden, 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.
Mazzucchelli TG, Kane RT, Rees CS. Behavioral activation interventions for well-being: A meta-analysis. J Posit Psychol. 2010 Mar;5(2):105-121. doi: 10.1080/17439760903569154. Epub 2010 May 7.
PubMed 20539837Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009 Nov;28(6):690-701. doi: 10.1037/a0016136.
PubMed 19916637Ponce, 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.
Thiart H, Lehr D, Ebert DD, Berking M, Riper H. Log in and breathe out: internet-based recovery training for sleepless employees with work-related strain - results of a randomized controlled trial. Scand J Work Environ Health. 2015 Mar;41(2):164-74. doi: 10.5271/sjweh.3478. Epub 2015 Jan 15.
PubMed 25590336Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res. 2010 Feb 17;12(1):e4. doi: 10.2196/jmir.1376.
PubMed 20164043
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web Application That Supports Behavior Change in Work Related Stress - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03077568
- Acronym / sponsor ID
- 2015/0646
- Keywords
- internet, web-based, behavior change, stress-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Stress Control | Experimental | Behavioral: My Stress ControlThis 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. |
| Wait-list group | No 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Score 17 or more on Perceived Stress Scale -14
- Able to read and speak Swedish
- Employed
- Consent to take part in the study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Stress ControlThe 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. | Behavioural | My Stress Control |
Primary outcome
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.
5 secondary outcomes
Motivation for Change Questionnaire
Time frame: Before intervention.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Background: PubMed 2782727Bandura A. Human agency in social cognitive theory. Am Psychol. 1989 Sep;44(9):1175-84. doi: 10.1037/0003-066x.44.9.1175.
- Background: PubMed 21513917Brinkborg H, Michanek J, Hesser H, Berglund G. Acceptance and commitment therapy for the treatment of stress among social workers: a randomized controlled trial. Behav Res Ther. 2011 Jun;49(6-7):389-98. doi: 10.1016/j.brat.2011.03.009. Epub 2011 Apr 5.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22113901Evers KE, Prochaska JM, Prochaska JO, Driskell MM, Cummins CO, Velicer WF. Strengths and weaknesses of health behavior change programs on the internet. J Health Psychol. 2003 Jan;8(1):63-70. doi: 10.1177/1359105303008001435.
- Background: PubMed 16846327Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population- and transtheoretical model-based stress-management intervention. Health Psychol. 2006 Jul;25(4):521-9. doi: 10.1037/0278-6133.25.4.521.
- Background: PubMed 20806849Hafner A, Stock A. Time management training and perceived control of time at work. J Psychol. 2010 Sep-Oct;144(5):429-47. doi: 10.1080/00223980.2010.496647.
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- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Söderlund, PhD principal investigator
Mälardalen University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Psychologic Stress and Occupation-Related Stress Disorder, run by Mälardalen University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077568, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.