Student Life @ Manchester: Evaluating a brief well-being planning intervention

ISRCTN	ISRCTN76730602
DOI	https://doi.org/10.1186/ISRCTN76730602
Secondary identifying numbers	N/A

Submission date: 11/08/2014
Registration date: 22/09/2014
Last edited: 07/05/2015

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Chris Armitage
Scientific

Manchester Centre for Health Psychology
Coupland Street
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 275 2556
Email	chris.armitage@manchester.ac.uk

Study information

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
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial to evaluate a self-affirmation implementation intention to target health and well-being in new university students
Study acronym	SL@M
Study objectives	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(s)	University of Manchester Committee on the ethics of research on human beings; 24/06/2014; reference ethics/14204
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/09/2014
Completion date	15/09/2034

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	3750
Key inclusion criteria	Student at the University of Manchester starting in 2014
Key exclusion criteria	Not a student at the University of Manchester starting in 2014
Date of first enrolment	15/09/2014
Date of final enrolment	01/10/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Manchester Centre for Health Psychology

Manchester
M13 9PL
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

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

"ROR"	https://ror.org/027m9bs27

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan