Condition category
Mental and Behavioural Disorders
Date applied
30/08/2012
Date assigned
11/09/2012
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Stress is very common and related to death and many different health conditions such as increased risk for coronary heart diseases, depression, and anxiety. Prolonged stress often causes symptoms such as fatigue, migraine, worries, lower back pain, pain in arms and shoulders that can have a negative effect on individuals and society (e.g. increased work absenteeism).
Stress management methods are known to reduce levels of stress and, as a result improve psychological and physical health. Personal counselling has a limited capacity to provide stress management, but easily accessible stress management methods may be more effective for larger numbers of people.
The aim of this project is to test the effects of a web-based stress management system ('NewMe Stresse Mindre').

Who can participate?
Anyone over 18 years old, who was invited via social media, and was able to provide a valid e-mail address.

What does the study involve?
The participants were randomly allocated to two groups. One group received the web-based system and the other group received no treatment. The web-based system consisted of 13 sessions in total and lasts for about a month. In addition, participants had to fill in web-based questionnaires at 1, 2, and 6 months after starting the study. The participants in the “no treatment” group were given access to the web-based system after the final data was collected.

What are the possible benefits and risks of participating?
Participants may have experienced decreases in their stress levels and learned techniques and exercises that they can apply as preventive efforts or during stressful life events any time later. There were no associated or expected risks of participating.

Where is the study run from?
University of Oslo in collaboration with Changetech AS.

When is study starting and how long is it expected to run for?
The study started in mid 2011 and data collection was ended in late 2011

Who is funding the study?
Research Council of Norway

Who is the main contact?
Mr Filip Drozd
fd@changetech.no

Trial website

Contact information

Type

Scientific

Primary contact

Mr Filip Drozd

ORCID ID

Contact details

Sletta 16
Askim
1807
Norway
+4797516188
filipdrozd@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A fully automated and web-based intervention for stress management: a randomized controlled trial

Acronym

Study hypothesis

1. The web-based stress management intervention is more effective in reducing levels of stress than the waitlist control group.
2. The effect of the stress management intervention is mediated through mindfulness and decisional procrastination.
3. The effects on levels of stress are not moderated by age, gender or educational levels.

Ethics approval

Norwegian Social Science Data Services, 13 May 2011, ref: 26816

Study design

A two-armed randomized controlled trial where the experimental group receives the web-based stress management program and the control group receives no treatment (i.e. a waitlist).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Participants from the normal population with a perceived need for stress management

Intervention

NewMe Stresse Mindre ('NewMe Less Stress') is a fully automated and web-based intervention. It consists of 13 sessions and lasts for about one month. There are three sessions per week. So every Monday, Wednesday, and Friday, users receive an email with a link to that particular sessions content. Each session is structured in two sections. The first section is psychoeducational and addresses a specific topic related to stress (e.g. procrastination or worries). The second section has different psychological techniques and exercises for dealing with stress. These techniques and exercises are related to the specific topic presented in the psychoeducational section. Furthermore, home assignments are given to do in-between sessions. NewMe Stresse Mindre takes on an ecclectic approach to stress management and applies information, techniques and exercises previously documented to be effective for stress reduction. This includes information, techniques and exercises from positive psychology, metacognitive therapy, and mindfulness-based cognitive-behavioural therapy. The control group (i.e. waitlist) did not receive any other treatment. They were, however, told that they would be given access to NewMe Stresse Mindre once the final data were collected approx. 6 months after study inclusion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

All patients were surveyed at baseline, 1, 2, and 6 months post-intervention enrollment:
Depression Anxiety Stress-Stress sub-scale (DASS-S; Lovibond & Lovibond, 1995)

Secondary outcome measures

1. Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003)
2. Melbourne Decision Making Questionnaire-Procrastination sub-scale (MDMQ-P; Mann, Burnett, Radford, & Ford, 1997).

Overall trial start date

01/05/2011

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All participants had to provide a valid e-mail address and be >= 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

It was estimated that we needed approx. 235 participants in total

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2011

Recruitment end date

01/05/2016

Locations

Countries of recruitment

Norway

Trial participating centre

Sletta 16
Askim
1807
Norway

Sponsor information

Organisation

Research Council of Norway (Norway)

Sponsor details

P. O. Box 2700
St. Hanshaugen
Oslo
0131
Norway

Sponsor type

Research council

Website

http://www.forskningsradet.no/

Funders

Funder type

Research council

Funder name

Research Council of Norway ref: 187979 (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23607962

Publication citations

  1. Results

    Drozd F, Raeder S, Kraft P, Bjørkli CA, Multilevel growth curve analyses of treatment effects of a Web-based intervention for stress reduction: randomized controlled trial., J. Med. Internet Res., 2013, 15, 4, e84, doi: 10.2196/jmir.2570.

Additional files

Editorial Notes