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

2018年3月20日 更新者:Mälardalen University

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.

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

95

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Västmanland
      • Västerås、Västmanland、スウェーデン、72123
        • School of Health, Care and Social Welfare; Mälardalen University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

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.

介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in perceive stress measured with Perceived Stress Scale -14
時間枠: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.
Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Motivation for Change Questionnaire
時間枠:Before intervention.
Wait-list will complete this measure for their corresponding "pre"-measure
Before intervention.
Change in self-efficacy believes for coping measured with Coping Self-Efficacy Scale
時間枠: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.
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
時間枠: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
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
時間枠: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
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
時間枠: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
Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Anne Söderlund, PhD、Mälardalen University, Sweden

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年12月1日

一次修了 (実際)

2017年12月1日

研究の完了 (実際)

2017年12月1日

試験登録日

最初に提出

2016年12月7日

QC基準を満たした最初の提出物

2017年3月7日

最初の投稿 (実際)

2017年3月13日

学習記録の更新

投稿された最後の更新 (実際)

2018年3月22日

QC基準を満たした最後の更新が送信されました

2018年3月20日

最終確認日

2018年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

No plan to share data

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

健康行動の臨床試験

My Stress Controlの臨床試験

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