Condition category
Not Applicable
Date applied
11/08/2014
Date assigned
22/09/2014
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Starting university is a major life change. It can involve moving away from home, taking the first steps in training for a new career or studying a completely new subject. Major life changes such as this can have a negative effect on well-being. This study (SL@M - Student life at Manchester) will test how well a brief planning intervention, or treatment based on making positive statements about yourself (self-affirmation) designed to reduce feelings of threat and anxiety, does in improving well-being and health. This study will also find out if using the same intervention (as a booster) at a later date will further improve well-being.

Who can participate?
Students who are starting a course at the University of Manchester in 2014.

What does the study involve?
Before starting university, participants are asked to complete a questionnaire about their lifestyle (i.e., details on how much fruit and vegetables they eat, how much alcohol they drink , how much they exercise, whether they smoke or take recreational drugs) and well-being (e.g., details about sleep, depression, anxiety). After completing the questionnaire participants are randomised to one of two groups. Those in group 1 receive the intervention. Those in group 2 act as controls. The intervention involves the student completing a self-affirmation task on an if-then basis to deal with threat and anxiety when it is encountered (e.g., If I am feeling threatened or anxious then I will think about the things that I value). Halfway through their university course, participants are randomised again either the intervention or control group. Lifestyle and well-being questionnaires are completed by all students every 6 months while at university and then every year for the next 20 years.

What are the possible benefits and risks of participating?
Participants who complete the self-affirmation implementation intention may experience an improvement in their well-being. There are no risks to taking part.

Where is the study run from?
University of Manchester (UK)

When is study starting and how long is it expected to run for?
The study will be started in September 2014 prior to the first semester of university. Recruitment will stop when university semester starts in October 2015. Follow-up questionnaires will be given for up to 20 years after the start of the study.

Who is funding the study?
University of Manchester (UK)

Who is the main contact?
Dr Tracy Epton
0161 2751972
epton.tracy@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Armitage

ORCID ID

Contact details

Manchester Centre for Health Psychology
Coupland Street
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2556
chris.armitage@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial to evaluate a self-affirmation implementation intention to target health and well-being in new university students

Acronym

SL@M

Study hypothesis

The main hypotheses are:
1. Halfway through their university course, group I (completed the self-affirmation implementation intention before starting university and halfway through their course) and group II (completed the self-affirmation before starting university only) will have greater health and well-being than the other two groups.
2. After finishing their course, group I will have greater health and well-being than the other three groups.
3. After finishing their course, group II and group III (completed self-affirmation implementation halfway through their course only) will have greater health and well-being than group IV (the control group did not complete self-affirmation implementation intention at either stage).

Ethics approval

University of Manchester Committee on the ethics of research on human beings; 24/06/2014; reference ethics/14204

Study design

Randomised controlled trial with the between-persons factor of condition with four levels

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

A psychological health intervention on a population of university students

Intervention

Participants will be randomised to two groups: self-affirmation implementation intention condition and a comparison group (control group who do not complete this task). Halfway through their course, participants will again be randomised to the above two groups. The four study arms are:
1. Self-affirmation implementation intention at the start and halfway through the university course
2. Self-affirmation implementation intention at the start of the university course and control group halfway through the university course
3. Control group at the start of the university course and self-affirmation implementation intention halfway through the university course
4. Control group at the start and halfway through the university course (control)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Perception of threatening life events
2. Depression
3. Anxiety
4. Well-being
Measured by questionnaire at baseline, 1, 6, 12, 18, 24, & 36 months after starting university and annually thereafter.

Secondary outcome measures

1. Fruit and vegetable consumption
2. Physical activity
3. Smoking status
4. Alcohol consumption
5. Recreational drug use
6. Sleep quality
7. Self-integrity
Measured by questionnaire at baseline, 1, 6, 12, 18, 24, & 36 months after starting university and annually thereafter.

Overall trial start date

15/09/2014

Overall trial end date

15/09/2034

Reason abandoned

Eligibility

Participant inclusion criteria

Student at the University of Manchester starting in 2014

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3750

Participant exclusion criteria

Not a student at the University of Manchester starting in 2014

Recruitment start date

15/09/2014

Recruitment end date

01/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Centre for Health Psychology
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Nalin Thakker
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Manchester (UK) - Manchester Centre for Health Psychology

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

Publication citations

Additional files

Editorial Notes