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

2018년 3월 20일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

95

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Västmanland
      • Västerås, Västmanland, 스웨덴, 72123
        • School of Health, Care and Social Welfare; Mälardalen University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in perceive stress measured with Perceived Stress Scale -14
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Motivation for Change Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Anne Söderlund, PhD, Mälardalen University, Sweden

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 12월 1일

기본 완료 (실제)

2017년 12월 1일

연구 완료 (실제)

2017년 12월 1일

연구 등록 날짜

최초 제출

2016년 12월 7일

QC 기준을 충족하는 최초 제출

2017년 3월 7일

처음 게시됨 (실제)

2017년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 20일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2015/0646

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

No plan to share data

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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