Condition category
Mental and Behavioural Disorders
Date applied
30/04/2013
Date assigned
15/05/2013
Last edited
14/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study investigates whether an internet website can help students reduce symptoms of common mental health problems, such as low mood, anxiety, drug and alcohol use and eating disorders. Although other websites of this kind already exist, they usually focus on symptoms of one disorder and are not targeted at students. In university students, however, symptoms of different mental health problems often go hand in hand. Our aim is to determine whether students will use this website and whether their low mood, anxiety and self-esteem problems decrease. In addition, we are interested in how much students like the website and to get feedback from them on how to improve it.

Who can participate?
All university students aged 18 or older and studying at a university in the UK were eligible to take part in this study.

What does the study involve?
Students visit the study website and after giving consent complete a set of baseline questionnaires. They receive automated feedback on these questionnaires and are randomised into the intervention or control group. Student in the intervention get access to a series of intervention modules, whereas the control group get access to general information relevant to students. These modules can be completed in any order and speed.
After 6 weeks and 12 weeks, students are asked to complete a series of questionnaires again. The questionnaires assess symptoms of mental health problems (low mood, anxiety, drug and alcohol use and eating disorders), self esteem and personality.

What are the possible benefits and risks of participating?
To compensate students for their time and as an incentive to participate in the study, participants are offered a £15 shopping voucher for completing all three assessments. Participation in this study is not associated with any risk for physical harm. It is possible that
some students find it difficult or upsetting to answer questions on their mental health. However, students do not have to answer all questions unless they want to and they can withdraw from the study at any time by leaving the website. In addition, students contact details of the primary investigator as well as telephone numbers for national helplines are provided on the website.

Where is the study run from?
The study was run from the Section of Eating Disorders, Institute of Psychiatry, King’s College London.

When is the study starting and how long is it expected to run for?
The study started in September 2011 and ran for 6 months. Each participants’ involvement in the study lasted approximately 12 weeks, beginning with registering on the website and ending with completion of the final set of questionnaire. Students registered at different times during this period.

Who is funding the study?
The study has been funded by the National Institute for Health Research (NIHR).

Who is the main contact?
Dr. Peter Musiat (peter.musiat@kcl.ac.uk)
Prof Ulrike Schmidt, Ulrike.schmidt@kcl.ac.uk (Supervisor)

Trial website

http://www.plusonline.org.uk

Contact information

Type

Scientific

Primary contact

Dr Peter Musiat

ORCID ID

Contact details

PO-Box 077
Institute Of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Web-based trait-focused prevention of common mental disorders in university students

Acronym

PLUS

Study hypothesis

Main hypothesis:
Students at high risk for common mental disorders (depression, anxiety, substance misuse, eating disorders) receiving the intervention will show significantly reduced levels of depression, anxiety and increased self-esteem compared to students at low risk and students in the control group at post-intervention (12 weeks).

Subsidiary hypotheses:
Students will find the personalized feedback and intervention content helpful and acceptable.

Ethics approval

Approval provided by King’s College London Research Ethics Committee, Psychiatry, Nursing & Midwifery Research Ethics Subcommittee (REF PNM 10/11-101) on May 16 2011

Study design

Multi centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Depression, anxiety, substance use, eating disorders

Intervention

Students allocated to the intervention group were given access to 5 intervention modules on the PLUS website (Personality and Living of University Students). The modules are online self-help resources and focus on perfectionism, how to improve self-esteem, dealing with difficult emotions and anxiety and worry. Students could also download a text version of each module. Copies of the interventions modules can be obtained from the contact above.

Students in the control group were given access to 3 online modules with general information for students. These modules cover how to find accommodation as a student, money saving tips as well as general study tips, such as time management.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Participant self-reported depression and anxiety assessed with the Patient Health Questionnaire (9 items) and the Generalised Anxiety Disorder Scale (7 items).
Questionnaires were administered at baseline, 6 weeks after randomisation and 12 weeks after randomisation.

Secondary outcome measures

1. Participant self-reported questionnaires assessing:
1.1. Self-esteem (Rosenberg Self-Esteem Scale, 10 items)
1.2. Perfectionism (Frost Multidimensional Perfectionism Scale, 36 items)
1.3. Personality (NEO-Five Factor inventory, 60 items)
1.4. Substance Use Risk Profile, 23 items)
1.5. Eating behaviour (Eating Disorder Diagnostics Scale, 22 items)
1.6. Drinking behaviour (Alcohol Use Disorder Identification Test, 10 items)
1.7. Quality of life (WHO quality of life questionnaire, 26 items)
2. In addition, students could indicate how much they liked the website, how helpful they found the modules and the personalised feedback, how they found the design and usability of the website, as well as whether they had criticism or positive remarks.
3. Attrition and feasibility was assessed by electronically logging which modules students had started and completed.

Overall trial start date

01/09/2011

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. University student (male or female) aged 18 or older
2. Currently enrolled in a UK Higher Education Institution

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2011

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PO-Box 077
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
Section of Eating Disorders
PO-Box 059
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/iop/index.aspx

Funders

Funder type

Government

Funder name

NIHR Biomedical Research Centre for Mental Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South London and Maudsley NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Psychiatry, King’s College London (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24736388

Publication citations

Additional files

Editorial Notes