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Trial registered on ANZCTR


Registration number
ACTRN12622000819729
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
10/06/2022
Date last updated
10/06/2022
Date data sharing statement initially provided
10/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tuned In University Students: An emotion regulation program using music listening.
Scientific title
Tuned In University Students: Examining the impact of a music listening group intervention on intrinsic emotion regulation and emotional distress.
Secondary ID [1] 307116 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion dysregulation 326278 0
Condition category
Condition code
Mental Health 323586 323586 0 0
Anxiety
Mental Health 323587 323587 0 0
Depression
Mental Health 323691 323691 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Music listening has been found to evoke a range of emotions and is the number one leisure activity among adolescents (Papinczak, Dingle, Stoyanov, Hides & Zelenko, 2015). The Tuned In program was developed in 2012 by Dr Genevieve Dingle as an experiential music-based program designed to increase emotion awareness and regulation for young people. The program uses participant-selected music to evoke emotions in sessions, and to facilitate psychoeducation about emotions and emotion regulation skills (Dingle, Hodges & Kunde, 2016). It involves listening to personalised music, evaluating the lyrics of songs, identifying the physical and emotional experience of music, and identifying the types of music that can be useful to listen to when experiencing emotions such as sadness, anger and happiness. More recently the program has been adapted to be provided via videoconferencing due to restrictions on face-to-face gatherings (Vidas, Nelson & Dingle, in press).

The current version of the Tuned In program for university students is comprised of four x 75 minute sessions delivered via Zoom by two facilitators (Masters of Psychology/Clinical Psychology interns) to 6-8 participants (first-year university students).

• Session one – Feelings are your friends. The first session provides psychoeducation about the different types of emotions people experience, the components of emotion and the functions of emotion, as well as how music fits in with these emotions.
• Session two – Fearing the worst. The second session focuses on academic anxiety, anticipatory anxiety, panic, and the body sensations associated with these feelings. The second session focuses on these experiences and shows how music listening could help to increase positive mood and reduce agitation.
• Session three - Stress less. The third session focuses on music to motivate and focus, to avoid procrastination, perfectionism, and rumination. Uplifting music is the focus for the latter two issues.
• Session four – Finding the fun. The final session focuses on the importance of fun for wellbeing, and ties together previous sessions and how music can help for celebration. This session reviews the program overall and discusses how to continue using strategies to get the benefits for mood and wellbeing.
Home practice: Participants are encouraged after sessions 2 and 3 to practice using music and developing playlists to regulate their stress and anxiety, particularly when engaging in academic tasks. Their music listening is expected to occur alongside their usual activities. Participants are not required to record anything between sessions.
Attendance: Participants' attendance of each group Zoom session is recorded by the facilitators. When participants are unable to attend a group session, their facilitators can arrange one catch up session per participant during the program.
Intervention code [1] 323570 0
Prevention
Intervention code [2] 323635 0
Behaviour
Comparator / control treatment
First year university students who have chosen to participate in the control group (i.e., complete surveys at beginning and end of the semester). The control group will be extracted from the dataset of the parent study: Sharper Minds (https://sharperminds.psy.uq.edu.au/about). In the Sharper Minds program, participants can chose between participating in one of six group programs (including Tuned In), a progress tracker app, or to be part of the control group. We will extract a matched control sample which will match the Tuned In intervention sample by age and gender.
Control group
Active

Outcomes
Primary outcome [1] 331346 0
Emotion Regulation of Others and Self (EROS) - Intrinsic affect improving subscale
Timepoint [1] 331346 0
Baseline (Week 2 - 6 of semester), and post-intervention (Week 8 - 12 of semester)
Primary outcome [2] 331347 0
Emotion Regulation of Others and Self (EROS) - Intrinsic affect worsening subscale
Timepoint [2] 331347 0
Baseline (Week 2 - 6 of semester), and post-intervention (Week 8 - 12 of semester)
Primary outcome [3] 331348 0
Psycheck - emotional distress screening tool
Timepoint [3] 331348 0
Baseline (Week 2 - 6 of semester), and post-intervention (Week 8 - 12 of semester)
Secondary outcome [1] 409595 0
Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [1] 409595 0
Baseline (Week 2 - 6 of semester), and post-intervention (Week 8 - 12 of semester)
Secondary outcome [2] 409596 0
Use of music for emotion regulation: Participants will rate how effective they find music listening to regulate their emotions on a scale from 1 = not at all successful to 9 = extremely successful, alongside other emotion regulation strategies drawn from Thayer, Newman, and McClain (1994).
Timepoint [2] 409596 0
Baseline (Week 2 - 6 of semester), and post-intervention (Week 8 - 12 of semester)
Secondary outcome [3] 409893 0
Qualitative data from two survey questions, in the post survey, asking participants what they liked about the program, and what they thought could be improved. Participants respond to these questions in writing.
Timepoint [3] 409893 0
Post-intervention (Week 8 - 12 of semester)

Eligibility
Key inclusion criteria
Students enrolled in a first year courses at University of Queensland
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Currently engaged in treatment for a serious mental health issue (such as clinical depression, bipolar disorder, eating disorder, psychosis)
• An inability to attend all four of the program sessions
• English proficiency that is insufficient for the student to engage in the group discussions and complete the assessments (with optional support from the researchers).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis indicated that a sample size of 54 would be required to detect a significant difference between groups with a medium effect size (f = .25) and 0.95 power, using the analyses planned (i.e., 2 x 2 mixed analysis of variance). Therefore, we aimed for a minimum of 30 participants in each group to account for some attrition, but we expect to have a total of around 60 participants in each group, allowing us to detect a small-medium effect size of (f = .17) with 0.95 power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/07/2021
Date of last participant enrolment
Anticipated
2/09/2022
Actual
Date of last data collection
Anticipated
28/10/2022
Actual
Sample size
Target
120
Accrual to date
112
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37528 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 311424 0
Commercial sector/Industry
Name [1] 311424 0
Allianz Insurance
Country [1] 311424 0
Australia
Funding source category [2] 311487 0
University
Name [2] 311487 0
University of Queensland DVCA
Country [2] 311487 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Attn: A/Prof Genevieve Dingle
School of Psychology
McElwain Building (24A)
The University of Queensland
St Lucia campus, QLD, 4072
Country
Australia
Secondary sponsor category [1] 312886 0
None
Name [1] 312886 0
Address [1] 312886 0
Country [1] 312886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310901 0
University of Queensland Human Research Ethics
Ethics committee address [1] 310901 0
Ethics committee country [1] 310901 0
Australia
Date submitted for ethics approval [1] 310901 0
Approval date [1] 310901 0
15/03/2021
Ethics approval number [1] 310901 0
2019/HE002846
Ethics committee name [2] 310949 0
University of Queensland - Human Research Ethics
Ethics committee address [2] 310949 0
Ethics committee country [2] 310949 0
Australia
Date submitted for ethics approval [2] 310949 0
Approval date [2] 310949 0
12/05/2021
Ethics approval number [2] 310949 0
2021/HE000275

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119282 0
A/Prof Genevieve Dingle
Address 119282 0
School of Psychology
McElwain Building (24A)
University of Queensland
St Lucia QLD 4072
Country 119282 0
Australia
Phone 119282 0
+61 7 336 57295
Fax 119282 0
Email 119282 0
g.dingle@psy.uq.edu.au
Contact person for public queries
Name 119283 0
Genevieve Dingle
Address 119283 0
School of Psychology
McElwain Building (24A)
University of Queensland
St Lucia QLD 4072
Country 119283 0
Australia
Phone 119283 0
+61 7 336 57295
Fax 119283 0
Email 119283 0
g.dingle@psy.uq.edu.au
Contact person for scientific queries
Name 119284 0
Genevieve Dingle
Address 119284 0
School of Psychology
McElwain Building (24A)
University of Queensland
St Lucia QLD 4072
Country 119284 0
Australia
Phone 119284 0
+61 7 336 57295
Fax 119284 0
Email 119284 0
g.dingle@psy.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The final cleaned data set with all de-identified individual participant data collected during the trial or a subset that is relevant to the data request.
When will data be available (start and end dates)?
Data available after publication of main results until 5 years post-publication
Available to whom?
Other researchers by request
Available for what types of analyses?
Reviews with meta analyses
How or where can data be obtained?
Data on the UQ Research Data Management system will be made available by emailing the principal investigator: dingle@psy.uq.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.