NCT03077568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

December 7, 2016

Last Update Submit

March 20, 2018

Conditions

Keywords

internetweb-basedbehavior changestress-management

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Before intervention.

  • Change in self-efficacy believes for coping measured with 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 perception of psychosocial factors at work measured with QPS Nordic-34+ for psychosocial factors at work

    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

    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

    Before intervention, at intervention completion an average of 12 weeks, and for a 3 and 6 month follow up after completed intervention

Study Arms (2)

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.

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.

Interventions

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.

My Stress Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Score 17 or more on Perceived Stress Scale -14
  • Able to read and speak Swedish
  • Employed
  • Consent to take part in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health, Care and Social Welfare; Mälardalen University

Västerås, Västmanland County, 72123, Sweden

Location

Related Publications (18)

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    PMID: 24844530BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    PMID: 20539837BACKGROUND
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    BACKGROUND
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    PMID: 25590336BACKGROUND
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    PMID: 20164043BACKGROUND
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    BACKGROUND
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  • Eklund C, Soderlund A, Elfstrom ML. Evaluation of a Web-Based Stress Management Program for Persons Experiencing Work-Related Stress in Sweden (My Stress Control): Randomized Controlled Trial. JMIR Ment Health. 2021 Dec 9;8(12):e17314. doi: 10.2196/17314.

MeSH Terms

Conditions

Stress, PsychologicalHealth Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Anne Söderlund, PhD

    Mälardalen University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

March 13, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations