Condition category
Mental and Behavioural Disorders
Date applied
04/12/2016
Date assigned
05/12/2016
Last edited
05/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
University students make up a category of people who are particularly vulnerable to stress. They are prone to having stress-related issues such as anxiety, depression, eating problems, consumption of psychoactive substances, and sleep disorders. These rates are higher in terms of mental health problems than declared in the general population. Online application studies in this field are being developed to treat several problems, such as panic disorder, depression, anxiety, insomnia, post traumatic stress, social phobia and behavioural problems. Stress management is one of the applications that has been suggested to help diverse population groups. The aim of this study is to test the efficiency of an online stress management program on university students.

Who can participate?
French university students aged between 18 and 30 who have access to the internet.

What does the study involve?
Participants are randomly allocated into one of the two groups. Those in the first group receive the online stress management program. Participants are invited to visit the website once a week and to spend at least 20 minutes on it for four weeks. They could visit the page for longer or more frequently if they wished. Those in the second groups continue as normal for the duration of the study. Participants in both groups complete a number of questionnaires to measure their stress levels and mental health at the start of the study and one week after the end of the program and after three months.

What are the possible benefits and risks of participating?
Participants may benefit from improvement in levels of self-esteem and perceived stress. There are no notable risks involved with participating.

Where is the study run from?
Université Paris Nanterre (France)

When is study starting and how long is it expected to run for?
November 2015 to June 2016

Who is funding the study?
Scientific Interest Group "Jeu et société" (France)

Who is the main contact?
Dalia Saleh
dalia_saleh84@yahoo.com

Trial website

https://sites.google.com/site/stressetudiantsuniversitairs/home

Contact information

Type

Scientific

Primary contact

Miss Dalia Saleh

ORCID ID

http://orcid.org/0000-0002-8459-5835

Contact details

2 avenue pozzo di borgo
studio 204
Saint-cloud France
92210
France
+33 658439809
dalia_saleh84@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Online stress management: An experimental study carried out on university students

Acronym

Study hypothesis

This aim of this study is to investigate the efficiency of an online stress management program.

Ethics approval

1. Ethics Committee of the Psychological Science and Learning Science department at the University of Paris Ouest Nanterre La Défense, UFR SPE (Department of Psychology and Education), 18/11/2014
2. CNIL (National commission of computing and freedom), 18/11/2014, ref: 1811031 v 0

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

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

Condition

Stress

Intervention

Participants are randomised to one of two groups using SPSS random sample software.

Intervention group: Participants receive the "I’m managing my stress" program. This involves four sessions spread over one month, each 20 minutes long, including psycho-education, practical exercises and one to two weekly activities that the participant is asked to complete (prescription of tasks, as is customary in cognitive-behavioural techniques). The goal is for the students to learn easy techniques to help them face stressing situations in a better way.

Control group: Participants continue as usual and are given the opportunity to receive the intervention program after the study ends.

Participants in both groups complete a battery of questionnaires at baseline (pre-intervention), one week post-intervention and again after three months.

Intervention type

Phase

Drug names

Primary outcome measures

1. Stress is assessed by the Perceived Stress Scale (PSS-10) at baseline, 1 week post-intervention and 3 months post-intervention
2. Self-esteem is measured using the Rosenberg Self-Esteem Scale (RSES) at baseline, 1 week post-intervention and 3 months post-intervention
3. Psychological distress is measured using the 28-item General Health Questionnaire (GHQ-28) at baseline, 1 week post-intervention and 3 months post-intervention

Secondary outcome measures

Satisfaction in studies is assessed using the 5-item version of (ESDE) at baseline, 1 week post-intervention and 3 months post-intervention.

Overall trial start date

01/11/2015

Overall trial end date

06/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. French university students
2. Mastery of the French language
3. Aged between 18 and 30
4. Having an e-mail address and access to the Internet

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

Aged under 18 or over 30

Recruitment start date

01/11/2015

Recruitment end date

10/01/2016

Locations

Countries of recruitment

France

Trial participating centre

Université Paris Nanterre
200 Avenue de la République
Nanterre
92001
France

Sponsor information

Organisation

Université Paris Nanterre

Sponsor details

200 Avenue de la République
Nanterre
92000
France
+ 33 1 40 97 72 00
webmaster@u-paris10.fr

Sponsor type

University/education

Website

http://www.u-paris10.fr/

Funders

Funder type

Research organisation

Funder name

Scientific Interest Group "Jeu et société"

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in either PLOS One or BMC in Psychiatry.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/07/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes