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Trial registered on ANZCTR


Registration number
ACTRN12623000009617
Ethics application status
Approved
Date submitted
24/10/2022
Date registered
9/01/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Empowering Sustainable Therapeutic Engagement with Music (ESTEEM): A Pilot Study of a Self-administered Music Therapy Program for Cardiac Rehabilitation Participants in Thailand
Scientific title
Empowering Sustainable Therapeutic Engagement with Music (ESTEEM): A Pilot Study of a Self-administered Music Therapy Program for Cardiac Rehabilitation Participants in Thailand
Secondary ID [1] 307905 0
None
Universal Trial Number (UTN)
Trial acronym
ESTEEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in cardiac rehabilitation participants 327544 0
Anxiety in cardiac rehabilitation participants 327545 0
Stress in cardiac rehabilitation participants 327546 0
Condition category
Condition code
Cardiovascular 324641 324641 0 0
Coronary heart disease
Cardiovascular 324645 324645 0 0
Other cardiovascular diseases
Mental Health 325638 325638 0 0
Anxiety
Mental Health 325639 325639 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to recruit 24 participants from Phase 2-3 cardiac rehabilitation program.

Consenting participants will participate in the Empowering Sustainable Therapeutic Engagement with Music (ESTEEM) program for 8 weeks at the hospital's cardiac rehabilitation unit. In this 8-week program, the participants will attend 4 fortnightly music therapy sessions alternating with 4 fortnightly phone check-ins. ESTEEM is a music therapy program that has been designed to enable people with CVDs in cardiac rehabilitation to develop capacity in self-administering music interventions to address their psychological wellbeing in the long term. Music interventions in this program consist of multiple music experiences with an emphasis on receptive and recreative experiences.

Music therapy sessions will be conducted for 2 hours once every 2 weeks (for 8 weeks; 4 sessions in total). Each session will consist of approximately 6 participants and a Registered Music Therapist (RMT) who will be facilitating the session.

Session structure:
1. Warm-up,
2. Learning about music interventions for self-administration,
3. Break: refreshments and social interaction,
4. Collaboratively tailoring the music interventions for each individual participant (i.e., the RMT will implement music therapy process and consider each participant's individual qualities such as music preference, preferred way to engage with music, musical background and relationship with music, preferred coping style, cultural background, etc.),
5. Experiencing the tailored music interventions,
6. Group discussion, reflection, and adjustment of the music interventions,
7. Wrap-up,
8. Post-session social interaction.

The participants will be encouraged to self-administer music independently in their daily lives whenever they need.

The intervention manual/diary will be provided to the participants to review their music interventions and to record their uses of music. All the materials have been developed specifically for this trial.

The alternating fortnightly phone check-ins are intended to check on how the participants are doing with using music on their own and to provide support if they need. This phone conversation with the RMT is expected to last approximately 15 minutes.
Intervention code [1] 324365 0
Treatment: Other
Comparator / control treatment
All participants will receive phase 2-3 cardiac rehabilitation program (depending on which phase they are in) as their standard care. The cardiac rehabilitation program at the research site focuses solely on the physical aspect and does not involve psychological care.

The control group will receive standard care only. After the intervention group finishes their program, the control group participants will be offered an opportunity to participate in the ESTEEM program.
Control group
Active

Outcomes
Primary outcome [1] 332457 0
Feasibility: Data on the number of participants, adverse event, feedback, and/or challenge encountered will be recorded by the researcher during the sessions and collected from the participant's self-reported diary.

Possible adverse events may include:
1. Psychological distress during the music therapy process.
2, COVID-19 and other contagious diseases at the research site (i.e., hospital).
3. Physical accidents (e.g., fall, bump) when using music in daily life.

In case of any adverse event, the participants are encouraged to contact the research staff immediately. The diary also allows the participants to self-report any distress or adverse event.
Timepoint [1] 332457 0
Throughout the course of the 8-week study and at the 3-month follow-up.
Primary outcome [2] 332458 0
Depression: The Thai language version of the Depression, Anxiety and Stress Scale 21 (DASS-21) (Lovibond & Lovibond, 1995; Oei et al., 2013).
Timepoint [2] 332458 0
Data collection will be conducted at (T0) baseline, (T1) week 4, and (T2 primary time point) week 8 after starting the program. The intervention group participants will attend a follow-up assessment at 3 months after the program.
Primary outcome [3] 332459 0
Anxiety: The Thai language version of the Depression, Anxiety and Stress Scale 21 (DASS-21) (Lovibond & Lovibond, 1995; Oei et al., 2013).
Timepoint [3] 332459 0
Data collection will be conducted at (T0) baseline, (T1) week 4, and (T2 primary time point) week 8 after starting the program. The intervention group participants will attend a follow-up assessment at 3 months after the program.
Secondary outcome [1] 413587 0
Stress (Primary Outcome): The Thai language version of the Depression, Anxiety and Stress Scale 21 (DASS-21) (Lovibond & Lovibond, 1995; Oei et al., 2013).
Timepoint [1] 413587 0
Data collection will be conducted at (T0) baseline, (T1) week 4, and (T2 primary time point) week 8 after starting the program. The intervention group participants will attend a follow-up assessment at 3 months after the program.
Secondary outcome [2] 413588 0
Participants' experience (Primary Outcome): Post-study semi-structured interviews will be conducted with all participants who complete the ESTEEM program. The questions will explore participants’ experience throughout the course of the study including the experiences of participating in the sessions, self-administering the music interventions, participating in the research process, and whether the participants were satisfied or had any suggestion for improvement. The participants' diaries will be collected for additional data on their experience.
Timepoint [2] 413588 0
Interviews will be conducted after the completion of the 8-week ESTEEM program. For those in the intervention group, another interview will be conducted at the 3-month follow-up to see if they continue to engage with music in a long term and reflect any further experience of self-administering music interventions during this timeframe. Diaries will be collected at week 8 and, for those in the intervention group, also at 3-month follow-up.

Eligibility
Key inclusion criteria
The participants will be recruited from the research site (i.e., a hospital cardiac rehabilitation unit in Bangkok, Thailand). The inclusion criteria are 1) adult participants in Phase 2-3 of the cardiac rehabilitation program of the research site hospital, 2) clinically stable and showing evidence of expected physical recovery, 3) physically independent, 4) intact cognitive functioning, 5) functional visual/hearing with or without aids, 6) fluent in Thai, 7) able to conveniently travel to the hospital for sessions and data collection, 8) express interest in using music to promote psychological wellbeing and willing to participate throughout the course of the study, and 9) consent to participate in the study and able to make consent independently.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The participants will be excluded if 1) have other health conditions that could be obstacles to participation (such as cognitive, sensory, or communication impairment, and uncontrolled health conditions), 2) have a history of psychiatric or neurological disorder that impedes their capacity to participate in the intervention, 3) have uncontrolled life-threatening condition, 4) participate in a concurrent research study and/or another lifestyle changing program other than cardiac rehabilitation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
24 participants will be block randomized to either the intervention arm or a wait-list control arm.

To ensure allocation concealment, the randomization list will be created by a member of the research team who is not involved in recruiting and screening participants. The list will be kept concealed until the commencement of the program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pilot/Feasibility Study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the feasibility aim of the study, descriptive statistics will be used to determine the success of recruitment, retention, compliance/adherence, and safety. The appropriateness of the measurement tool will be determined based on the results from the quantitative analysis. The intervention acceptability and challenge will be determined based on the participants’ experience and incident records.

For the quantitative aim of the study, the score of Thai DASS-21 and its subscales will be calculated. Normality test will be performed on the collected data. Then, appropriate inferential statistics will be selected to measure within-group and between-group differences at each time point of the study. Secondary pre-post analysis will also be performed by pooling data from all participants who completed the ESTEEM program including those in the control group who later receive the program.

For the qualitative aim of the study, thematic analysis will be implemented to identify, analyze, and report patterns (i.e., themes) within data derived from the post-study interview transcriptions and diaries of the ESTEEM participants (Braun & Clarke, 2006).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2023
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 24993 0
Thailand
State/province [1] 24993 0
Bangkok

Funding & Sponsors
Funding source category [1] 312177 0
University
Name [1] 312177 0
The Faculty of Fine Arts and Music, The University of Melbourne (Faculty Graduate Researcher Fund)
Country [1] 312177 0
Australia
Funding source category [2] 312179 0
University
Name [2] 312179 0
The University of Melbourne (Melbourne Research Scholarship)
Country [2] 312179 0
Australia
Funding source category [3] 312180 0
Charities/Societies/Foundations
Name [3] 312180 0
Palang Jai Manarom Foundation
Country [3] 312180 0
Thailand
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 313704 0
None
Name [1] 313704 0
Address [1] 313704 0
Country [1] 313704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311562 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 311562 0
Human Ethics Team
Office of Research Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010
Ethics committee country [1] 311562 0
Australia
Date submitted for ethics approval [1] 311562 0
02/05/2022
Approval date [1] 311562 0
30/08/2022
Ethics approval number [1] 311562 0
2024-24219-48513-7

Summary
Brief summary
The Empowering Sustainable Therapeutic Engagement with Music (ESTEEM) program focuses on enabling people with cardiovascular diseases (CVDs) in cardiac rehabilitation to develop capacity in self-administering music interventions to address their psychological wellbeing.

There are three aims of this pilot study: 1) to determine the feasibility of the ESTEEM program for people with CVDs undergoing cardiac rehabilitation, 2) to collect pilot data necessary for determining the sample size for a larger trial in the future (i.e., depression, anxiety, and stress), and 3) to gather information about the participants’ experience.

To fulfill these aims, a mixed-method experimental design utilizing randomized controlled trial and semi-structured interview will be implemented. Participants will be randomized to either the intervention group or a waitlist control group. Information will be collected regarding the feasibility of the ESTEEM program and research process, the participants' psychological wellbeing (i.e., depression, anxiety, and stress), and the participants' experience participating in the program and the research process. This mixed-method design enables more comprehensive understanding of the intervention by embedding qualitative data into a randomized controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121550 0
Dr Jeanette Tamplin
Address 121550 0
The University of Melbourne (Southbank Campus)
234 St Kilda Road, Southbank
Victoria 3006
Country 121550 0
Australia
Phone 121550 0
+61 3 9035 6787
Fax 121550 0
Email 121550 0
jeanette.tamplin@unimelb.edu.au
Contact person for public queries
Name 121551 0
Mr Napak Pakdeesatitwara
Address 121551 0
The University of Melbourne (Southbank Campus)
234 St Kilda Road, Southbank
Victoria 3006
Country 121551 0
Australia
Phone 121551 0
+61 4 5057 0774
Fax 121551 0
Email 121551 0
npakdeesatit@student.unimelb.edu.au
Contact person for scientific queries
Name 121552 0
Mr Napak Pakdeesatitwara
Address 121552 0
The University of Melbourne (Southbank Campus)
234 St Kilda Road, Southbank
Victoria 3006
Country 121552 0
Australia
Phone 121552 0
+61 4 5057 0774
Fax 121552 0
Email 121552 0
npakdeesatit@student.unimelb.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?
All de-identified data collected during the study.
When will data be available (start and end dates)?
Immediately following publication. The summary record of research data will be permanently retained as University archives. Datasets created from clinical trials will be temporarily retained for 15 years after completion of research activity, then destroyed.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Via email to Dr Jeanette Tamplin: jeanette.tamplin@unimelb.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17085Ethical approval  jeanette.tamplin@unimelb.edu.au 384623-(Uploaded-10-01-2024-19-48-54)-Study-related document.pdf
20727Ethical approval    384623-(Uploaded-17-10-2023-17-04-58)-Study-related document.pdf



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.