A fully automated and web-based intervention for stress management

ISRCTN ISRCTN25619675
DOI https://doi.org/10.1186/ISRCTN25619675
Secondary identifying numbers N/A
Submission date
30/08/2012
Registration date
11/09/2012
Last edited
08/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Filip Drozd
Scientific

Sletta 16
Askim
1807
Norway

Phone +4797516188
Email filipdrozd@gmail.com

Study information

Study designA 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA fully automated and web-based intervention for stress management: a randomized controlled trial
Study objectives1. 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(s)Norwegian Social Science Data Services, 13 May 2011, ref: 26816
Health condition(s) or problem(s) studiedParticipants from the normal population with a perceived need for stress management
InterventionNewMe 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 typeOther
Primary outcome measureAll 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 measures1. Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003)
2. Melbourne Decision Making Questionnaire-Procrastination sub-scale (MDMQ-P; Mann, Burnett, Radford, & Ford, 1997).
Overall study start date01/05/2011
Completion date01/05/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsIt was estimated that we needed approx. 235 participants in total
Key inclusion criteriaAll participants had to provide a valid e-mail address and be >= 18 years
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/05/2011
Date of final enrolment01/05/2016

Locations

Countries of recruitment

  • Norway

Study participating centre

Sletta 16
Askim
1807
Norway

Sponsor information

Research Council of Norway (Norway)
Research council

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

Website http://www.forskningsradet.no/
ROR logo "ROR" https://ror.org/00epmv149

Funders

Funder type

Research council

Research Council of Norway ref: 187979 (Norway)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/04/2013 Yes No