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Trial registered on ANZCTR


Registration number
ACTRN12608000472370
Ethics application status
Approved
Date submitted
12/09/2008
Date registered
23/09/2008
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
'Songs for Life': Group music therapy for serious and enduring mental illness (SEMI) - a randomised control trial
Scientific title
Evaluation of a group music therapy program on quality of life in people living with severe and enduring mental illness (SEMI) in the community
Secondary ID [1] 283837 0
nil known
Universal Trial Number (UTN)
Trial acronym
'Songs for Life'
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe and enduring mental illness 3665 0
Schizophrenia and other psychotic disorders 3666 0
Bipolar disorder and major depression 3676 0
Condition category
Condition code
Mental Health 3833 3833 0 0
Schizophrenia
Mental Health 3834 3834 0 0
Psychosis and personality disorders
Mental Health 3835 3835 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group music therapy intervention comprising the following (4) treatment components: singing preferred and familiar songs; percussive improvisation; writing an original song; recording an original song. The intervention will be a 13-week group music therapy progam, delivered by a registared music therapist (RMT). The program comprises one Introductory Session, and 12 group music therapy sessions, with session length of one hour. The original song will be recorded in a professional recording studio and a CD will be given to participants at the end of the program. Music therapy is a recognised psychosocial intervention that involves a wide range of musical applications, including improvisation, instrument playing, singing/vocalising, composition, song/lyric writing, music and movement, listening, performance and music imagery. Music therapy interventions are selected according to the unique needs of particular individuals or groups, and offer participants the opportunity to interact musically and socially in the context of a therapeutic relationship. The effectiveness of music therapy, especially active music-making, for people with SEMI has been demonstrated (Gold, Heldal, Dahle & Wigram, 2005).
Intervention code [1] 3381 0
Treatment: Other
Intervention code [2] 3382 0
Behaviour
Intervention code [3] 3383 0
Other interventions
Comparator / control treatment
The control condition will be a waitlist control in which all participants will receive group music therapy, either immediately after randomisation, or following a 3-month waiting period.
Control group
Active

Outcomes
Primary outcome [1] 4731 0
Statistically significant changes in Quality of Life, as measured by the Quality of Life Enjoyment and Satisfaction Questionniare (Q-LES-Q-18; Ritsner, Kurs, Gibel, Ratner & Endicott, 2005). The Q-LES-Q-18 is an 18-item self-report inventory that assesses quality of life in four domains: social relationships, physical health, subjective feelings, and leisure-time activities. The instrument represents a parsimonious subset of items that maintains the validity and psychometric properties of the longer 60-item version. The Q-LES-Q-18 is suitable for the evaluation of quality of life outcomes in clinical trials involving participants with schizophrenia, shizoaffective, and mood disorders.
Timepoint [1] 4731 0
Participants randomised to the music condition will be assessed at three points: pre-treatment (immediately following randomisation), Week 13 (post-treatment) and follow-up (3 months after post-treatment assessment).
Participants randomised to the wailtlist condition will be assessed at four timepoints: Beginning of waitlist (3 months before intervention), pre-treatment, Week 13 (post-treatment), and follow-up (3 months after post-treatment assessment).
Secondary outcome [1] 7987 0
Statistically significant changes in perceived social support, as measured by the ENRICHD Social Support Instrument (ESSI; Barefoot et al., 2003). The ESSI is a 7-item self-report inventory that has demonstrated utility in assessing the role of social support in health outcomes (Vaglio et al, 2004).
Timepoint [1] 7987 0
Participants randomised to the music condition will be assessed at three points: pre-treatment (immediately following randomisation), Week 13 (post-treatment) and follow-up (3 months after post-treatment assessment).
Participants randomised to the wailtlist condition will be assessed at four timepoints: Beginning of waitlist (3 months before intervention), pre-treatment, Week 13 (post-treatment), and follow-up (3 months after post-treatment assessment).
Secondary outcome [2] 7988 0
Statistically significant changes in self-esteem, as measured by the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965). The RSES is a widely used 10-item self-report inventory for evaluating individual self-esteem.
Timepoint [2] 7988 0
Participants randomised to the music condition will be assessed at three points: pre-treatment (immediately following randomisation), Week 13 (post-treatment) and follow-up (3 months after post-treatment assessment).
Participants randomised to the wailtlist condition will be assessed at four timepoints: Beginning of waitlist (3 months before intervention), pre-treatment, Week 13 (post-treatment), and follow-up (3 months after post-treatment assessment).
Secondary outcome [3] 7989 0
Statistically significant changes in spirituality, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp; Peterman et al., 2002). The FACIT-Sp is a popular 12-item self-report measure of the religious/spiritual (R/S) components of quality of life (QoL) in patients with cancer (Carmody et al., 2008). Qualitative analysis of song lyrics in the pilot study for this project revealed strong religious and meaning-related themes. Thus, the inclusion of a quantitative outcome measure of spirituality.
Timepoint [3] 7989 0
Participants randomised to the music condition will be assessed at three points: pre-treatment (immediately following randomisation), Week 13 (post-treatment) and follow-up (3 months after post-treatment assessment).
Participants randomised to the wailtlist condition will be assessed at four timepoints: Beginning of waitlist (3 months before intervention), pre-treatment, Week 13 (post-treatment), and follow-up (3 months after post-treatment assessment).
Secondary outcome [4] 7990 0
Psychiatric symptoms, as measured by the Brief Symtpom Inventory (BSI; Derogatis, 1993). The BSI is 53-item brief self-report inventory that reflects psychopathology and psychological distress in nine symptom dimensions and three global indices. This instrument is appropriate for a broad range of diagnoses and is useful in evaluating treatment outcome. We are expecting that psychiatric symptoms will remain unchanged pre- and post-intervention.
Timepoint [4] 7990 0
Participants randomised to the music condition will be assessed at three points: pre-treatment (immediately following randomisation), Week 13 (post-treatment) and follow-up (3 months after post-treatment assessment).
Participants randomised to the wailtlist condition will be assessed at four timepoints: Beginning of waitlist (3 months before intervention), pre-treatment, Week 13 (post-treatment), and follow-up (3 months after post-treatment assessment).
Secondary outcome [5] 8003 0
Clinically significant and self-reported meaningful change in quality of life, perceived social support, self-esteem, and spirituality (sense of meaning and purpose) as measured by focus group interview.
Timepoint [5] 8003 0
Post-intervention assessment (Week 13)

Eligibility
Key inclusion criteria
The inclusion criteria are not diagnosis-specific, such that people living with a broad range of mental illnesses can participate. Musical experience or ability is not necessary.

Specific inclusion criteria: 1) a diagnosed severe and enduring mental illness (e.g., schizophrenia, bipolar disorder, major depression) that has been present for a least two years; 2) living independently in the community; 3) currently linked with a mental health professionial, case manager, or primary care physician; 3) ability to participate in a group for 1.5 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Behavioural issues that may be disruptive to a group process. Inability to speak english or give informed consent.

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)
Recruitment will occur via in-servicing and advertisement at mental health centres and through case managers. Potential participants will be assessed for suitability via screening interview and/or discussion with case manager. After participants give consent, baseline assessment will be undertaken by the research assistant (RA). Participants will then be individually randomised to either the treatment (music therapy) or control (waitlist) condition using central randomisation by email or computer. Participants, therapists, and the RA will all be aware of the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Late in the trial small numbers of recruited participants could not be randomized to groups. Thus the design was amended to facilitate a non-randomized arm. These participants were assigned to Group Music Therapy, followed by standard care. Their data was collected at the same time points as the randomized participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Test power was calculated for the primary out- come. We expected a sample size of 120 to be real- istic to achieve and expected about 20% loss to follow-up, leading to an available sample size of 96. In line with previous systematic reviews, we expected a medium effect size (d = 0.50), but con- sidered that this effect size could be somewhat reduced due to clustering. In a two-sided paired t-test, the target sample size would still have 80% power if the effect size was as low as 0.29 (and near 100% for d = 0.50; calculated with R function power.t.test).
An independent statistician carried out all statistical analyses, using R version 3.0.1. All statistical tests were two-tailed with a 5% significance level. Baseline characteristics were compared between groups using Welch t-tests for continuous variables and Fisher’s exact tests for categorical variables. Effects of GMT were evaluated based on paired t-tests comparing the change scores between conditions (i.e. the change during GMT vs. the change during SC; excluding the second SC period in those randomized to SC-GMT-SC). In addition, effect sizes (Cohen’s d) were calculated. Because the aim of the effect size calculations was to facilitate clinical interpretation, we divided mean differences as well as their confidence limits by baseline standard deviations.
Effects were analyzed on an intention-to-treat basis in the main analysis. This means that all available data were analyzed, and no participants were excluded if they failed to attend sessions. Listwise deletion of missing values was used in the main analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2009
Actual
20/04/2009
Date of last participant enrolment
Anticipated
Actual
29/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1885 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 1886 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 1887 0
The Melbourne Clinic - Richmond
Recruitment hospital [4] 1888 0
Albert Road Clinic - Melbourne
Recruitment postcode(s) [1] 1143 0
3022
Recruitment postcode(s) [2] 1144 0
3123

Funding & Sponsors
Funding source category [1] 3847 0
Government body
Name [1] 3847 0
Australian Research Council Discovery Projects
Country [1] 3847 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, 3010, Victoria
Country
Australia
Secondary sponsor category [1] 3459 0
Hospital
Name [1] 3459 0
St Vincent's Mental Health
Address [1] 3459 0
46 Nicholson St, Fitzroy, 3065
Country [1] 3459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5898 0
Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 5898 0
Ethics committee country [1] 5898 0
Australia
Date submitted for ethics approval [1] 5898 0
Approval date [1] 5898 0
26/02/2008
Ethics approval number [1] 5898 0
0722802
Ethics committee name [2] 5905 0
St Vincent's Health and Research Ethics Committee-A
Ethics committee address [2] 5905 0
Ethics committee country [2] 5905 0
Australia
Date submitted for ethics approval [2] 5905 0
19/09/2008
Approval date [2] 5905 0
Ethics approval number [2] 5905 0

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

Contacts
Principal investigator
Name 28917 0
Prof Professor Denise Grocke
Address 28917 0
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne 3010
Country 28917 0
Australia
Phone 28917 0
+61-3-8344-5259
Fax 28917 0
Email 28917 0
[email protected]
Contact person for public queries
Name 12074 0
Professor Denise Grocke
Address 12074 0
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne 3010
Country 12074 0
Australia
Phone 12074 0
+ 61 3 8344 5259
Fax 12074 0
Email 12074 0
[email protected]
Contact person for scientific queries
Name 3002 0
Prof Denise Grocke
Address 3002 0
Melbourne Conservatorium of Music
151 Barry Street
University of Melbourne 3010
Country 3002 0
Australia
Phone 3002 0
+61 3 83445259
Fax 3002 0
Email 3002 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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