Condition category
Mental and Behavioural Disorders
Date applied
07/02/2017
Date assigned
16/02/2017
Last edited
13/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Starting university can be a challenging experience, leading to a loss of identity and feelings of social disconnection. This period can be critical in terms of emerging mental health issues and/or the worsening of existing problems with mental wellbeing. Evidence from support services suggests that recently there have been an increased number of referrals for mental health issues, particularly anxiety and depression, and especially within new students. Many existing services are over-subscribed, with lengthy waiting lists. Research has demonstrated that music programs such as songwriting or singing may help to reduce mental distress and improve social engagement. Songwriting is a universally accessible process and popular art form, which is being used with a wide range of people. Therapeutic songwriting operates through a mechanism of change, which allows participants to reflect upon and engage with their experiences. Whilst the act of group participation in this type of activity is also known to promote social bonding. The aim of this study is to find out whether taking part in a short, weekly, songwriting program can help lower distress and improve wellbeing in first year university students.

Who can participate?
First year students registered at Canterbury Christ Church University, who self-identify as stressed.

What does the study involve?
Participants are randomly allocated to one of two groups. One group attends a one and a half hour interactive songwriting workshop, led by an experienced music workshop leader, once a week for five weeks. The other group are placed on a waiting list and do not take part in any additional activities during the study period. At the start of the study and again five weeks later, participants in both group complete questionnaires to assess their anxiety and depression levels, general wellbeing and loneliness.

What are the possible benefits and risks of participating?
Participants may benefit from improved mental wellbeing and enjoying taking part in a shared musical and social experience. The possible risks of taking part include any upset caused by discomfort in response to the songwriting work. Psychologists and workshop leaders will monitor participants' apparent state and behaviour throughout, and take any action where necessary to avoid any negative impact.

Where is the study run from?
Canterbury Christ Church University (UK)

When is the study starting and how long is it expected to run for?
February 2017 to September 2017

Who is the main contact?
Dr Kate Gee

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Gee

ORCID ID

http://orcid.org/0000-0002-9797-4594

Contact details

Canterbury Christ Church University
LF14
School of Psychology
Politics and Sociology
North Holmes Road
Canterbury
CT1 1QU
United Kingdom
+44 1227 767700 ext 3916
kate.gee@canterbury.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N00525 Heif 11-15

Study information

Scientific title

Blue Notes: A pilot randomised controlled trial using songwriting as an intervention to alleviate student mental health and wellbeing

Acronym

Blue Notes

Study hypothesis

Participation in a short, weekly, songwriting intervention may help lower student distress and improve student wellbeing.

Ethics approval

Canterbury Christ Church University, 26/10/2016, ref: 16/SAS/319C

Study design

Randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Stress

Intervention

Participants will be randomised individually with stratified allocation to the intervention and control groups.

Intervention group: Participants undertake group musical intervention, as facilitated by an experienced songwriter and community practitioner, under the guidance of a music psychologist. The treatment will take a songwriting focus and will run for 5 weeks, once a week, within a university location. The final session will be an opportunity to record their songs within a university recording studio.

Control group: Participants are placed on a waiting list for the duration of the intervention.

Follow up will occur one month after the end of the project. The waitlist control will then be offered the intervention at the end of the project.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Anxiety and depression, as measured using The Hospital Anxiety and Depression Scale (HADS) at baseline and 5 weeks.

Secondary outcome measures

1. Subjective wellbeing measured using the Satisfaction with life scale (SWLS) at baseline and 5 weeks.
2. Loneliness is measured using the UCLA Loneliness Scale at baseline and 5 weeks

Overall trial start date

01/10/2014

Overall trial end date

10/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. First year students studying at Canterbury Christ Church University
2,. Aged 18 years and over
3. Self-identify as stressed or having been diagnosed or have self diagnosed with mild forms of depression and/or anxiety as measured by the baseline scale scores

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Under 18 years of age
2. Not attending Canterbury Christ Church University
3. Severe mental health problems

Recruitment start date

01/01/2017

Recruitment end date

13/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Canterbury Christ Church University
LF14 (Laud) School of Psychology Politics and Sociology North Holmes Road
Canterbury
CT11QU
United Kingdom

Sponsor information

Organisation

Canterbury Christ Church University

Sponsor details

North Holmes Road
Canterbury
CT1 1QU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Higher Education Funding Council for England

Alternative name(s)

HEFCE

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication is planned within a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the study are unknown, data will be made available at a later date.

Intention to publish date

31/05/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes