Indicated web-based prevention of mental disorders in undergraduate university students

• Register: ISRCTN
• Last refreshed on: 29 July 2019
• Main ID: ISRCTN15570935
• Date of registration: 18/02/2016
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Indicated web-based prevention of mental disorders in undergraduate university students
• Scientific title: Indicated web-based prevention of mental disorders in undergraduate university students: randomised controlled trial of a web-based cognitive behavioural intervention and a web-based active control intervention for the reduction of depression and anxiety
• Date of first enrolment: 01/09/2016
• Target sample size: 5550
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15570935
• Study type: Interventional
• Study design: Multi-centre two arm prospective parallel group randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Austria, United Kingdom

Contacts

• Name: Peter Musiat

Key inclusion & exclusion criteria

Inclusion criteria:
Current participant inclusion criteria as of 09/07/2019:
1. Students at any UK or Austrian University
2. Age at least 18 years

Previous participant inclusion criteria:
1. First-year students at any UK or Austrian University
2. Age at least 18 years

Exclusion criteria:
1. Any current common diagnosed mental disorder or history of a common mental health disorder in the past 12 months
2. Have received psychotherapeutic treatment for any common mental disorder in the past 12 months
3. Current acutely suicidality (as assessed with question 9 of the PHQ9, score > 1)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Depression, anxiety, substance use disorders and eating disorders.
Mental and Behavioural Disorders

Intervention(s)

Participants are randomly allocated to one of two groups:
1. Intervention group: PLUS (Personality and Living of University Students) is a web-based intervention for the prevention of depression, anxiety, substance use disorders and eating disorders in university students. It is based on the intervention investigated in a previous RCT (Musiat et al., 2014). It follows a cognitive-behavioural approach and consists of seven modules. The modules target personality risk factors for common mental health problems in students i.e. low self-esteem, high perfectionism and anxiety; and how to deal with difficult emotions. They were designed to help students with identifying cycles of unhelpful behaviour and breaking such cycles. Students in the prevention group can optionally download the content of the modules as PDF for offline use. During the intervention stage, students of both groups will receive an email reminder to invite them to visit the site regularly (maximum number of emails over study duration: 10). The modules are designed to be completed by students independently and without personal support.
2. Active control: The active control condition is a web-based intervention, which consists of several modules addressing issues commonly experienced by undergraduate students. They provide information on finding accommodation when studying away from home, tips for saving money and managing finances at university, and tips on time management and how to work effectively with academic texts. These modules have been developed in collaboration with undergraduate students.

All participants can access their web-based intervention for a period of 12 weeks post randomisation.

Primary Outcome(s)

1. Severity of depression, as assessed by the Patient Health Questionnaire (PHQ-9)
2. Severity of anxiety, as assessed by the Generalised Anxiety Disorder Assessment (GAD-7)

Assessment points: baseline, 3 months, 6 months and 12 months post randomisation

Secondary Outcome(s)

1. Alcohol consumption, assessed by the AUDIT (Alcohol Use Disorders Identification Test)
2. Drug use, assessed by the DUDIT (Drug Use Disorders Identification Test)
3. Severity of eating disorders, assessed by the EDDE (Eating Disorders Diagnostics Scale)
4. Quality of life, assessed by the WHOQOL-bref (WHO Quality of Life)
5. Self-esteem, assessed using the RSE (Rosenberg Self-Esteem scale)
6. Costs of care, assessed by the CSRI (Client Service Receipt Inventory)

Assessment points: baseline, 3 months, 6 months and 12 months post randomisation

Secondary ID(s)

N/A

Source(s) of Monetary Support

European Commission

Ethics review

Status:
Approval date:
Contact:

1. King's College London Psychiatry, Nursing and Midwifery Research Ethics Sub-Committee, ref: PNM/14/15-130 2. Researcher Ethics Committee of the Medical University Vienna, ref: 2208/2015

Results

• Results available: Yes
• Date Completed: 31/08/2018