ISRCTN ISRCTN13709272
DOI https://doi.org/10.1186/ISRCTN13709272
Secondary identifying numbers N/A
Submission date
04/12/2016
Registration date
05/12/2016
Last edited
04/01/2024
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

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 years 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 group 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

Study website

Contact information

Miss Dalia Saleh
Scientific

2 avenue pozzo di borgo
studio 204
Saint-cloud France
92210
France

ORCiD logoORCID ID 0000-0002-8459-5835
Phone +33 658439809
Email dalia_saleh84@yahoo.com

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleOnline stress management: An experimental study carried out on university students
Study hypothesisThis aim of this study is to investigate the efficiency of an online stress management program.
Ethics approval(s)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
ConditionStress
InterventionParticipants 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 typeBehavioural
Primary outcome measure1. 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 measuresSatisfaction in studies is assessed using the 5-item version of (ESDE) at baseline, 1 week post-intervention and 3 months post-intervention.
Overall study start date01/11/2015
Overall study end date06/06/2016

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
Upper age limit30 Years
SexBoth
Target number of participants128
Participant inclusion criteria1. French university students
2. Mastery of the French language
3. Aged between 18 and 30 years
4. Having an e-mail address and access to the Internet
Participant exclusion criteriaAged under 18 or over 30 years
Recruitment start date01/11/2015
Recruitment end date10/01/2016

Locations

Countries of recruitment

  • France

Study participating centre

Université Paris Nanterre
200 Avenue de la République
Nanterre
92001
France

Sponsor information

Université Paris Nanterre
University/education

200 Avenue de la République
Nanterre
92000
France

Phone + 33 1 40 97 72 00
Email webmaster@u-paris10.fr
Website http://www.u-paris10.fr/
ROR logo "ROR" https://ror.org/013bkhk48

Funders

Funder type

Research organisation

Scientific Interest Group "Jeu et société"

No information available

Results and Publications

Intention to publish date31/07/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in either PLOS One or BMC in Psychiatry.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 05/09/2018 Yes No
Protocol (other) 05/09/2018 04/01/2024 No No

Editorial Notes

04/01/2024: Protocol link added.
06/09/2018: Publication reference added.

Springer Nature