Evaluation of a Web Application That Supports Behavior Change in Work Related Stress
Condition: Psychologic Stress; Occupation-Related Stress Disorder; Health Behavior
MeSH terms: Occupational Stress; Stress, Psychological
Study type: Interventional

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.
    

Intervention name(s): My Stress Control
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: internet; web-based; behavior change; stress-management