Recruiting Participants for Randomized Controlled Trials of Music Therapy: A Practical Illustration

Background: Failure to recruit sufficient numbers of participants to randomized controlled trials is a common and serious problem. This problem may be additionally acute in music therapy research.

Objective: To use the experience of conducting a large randomized controlled trial of music therapy for young people with emotional and behavioral difficulties to illustrate the strategies that can be used to optimize recruitment; to report on the success or otherwise of those strategies; and to draw general conclusions about the most effective approaches.

Methods: Review of the methodological literature, and a narrative account and realist analysis of the recruitment process.

Results: The strategies adopted led to the achievement of the recruitment target of 250 subjects, but only with an extension to the recruitment period. In the pre-protocol stage of the research, these strategies included the engagement of non-music therapy clinical investigators, and extensive consultation with clinical stakeholders. In the protocol development and initial recruitment stages, they involved a search of systematic reviews of factors leading to under-recruitment and of interventions to promote recruitment, and the incorporation of their insights into the research protocol and practices. In the latter stages of recruitment, various stakeholders including clinicians, senior managers and participant representatives were consulted in an attempt to uncover the reasons for the low recruitment levels that the research was experiencing.

Conclusions: The primary mechanisms to promote recruitment are education, facilitation, audit and feedback, and time allowed. The primary contextual factors affecting the effectiveness of these mechanisms are professional culture and organizational support.

Music therapy for end-of-life care: an updated systematic review

Background: Music therapy during palliative and end-of-life care is well established and positive benefits for patients have been reported.
Aim: Assess the effectiveness of music therapy versus standard care alone or standard care in combination with other therapies for improving psychological, physiological and social outcomes among adult patients in any palliative care setting.
Data sources: In order to update an existing Cochrane systematic review, we searched MEDLINE, CINAHL, EMBASE, PsycINFO, CENTRAL, ClinicalTrials.gov register, and Current Controlled Trials register to identify randomised or quasi-randomised controlled trails published between 2009 and April 2015. Nine electronic music therapy journals were searched from 2009 until April 2015, along with reference lists and contact was made with key experts in music therapy. Only studies published in English were eligible for inclusion. Two reviewers independently screened titles, abstracts, assessed relevant studies for eligibility, extracted data and judged risk of bias for included studies. Disagreements were resolved through discussion with a third reviewer. Data were synthesised in Revman using the random effects model. Heterogeneity was assessed using l2.
Results: Three studies were included in the review. Findings suggest music therapy may be effective for helping to reduce pain in palliative care patients (standard mean deviation (SMD) = -0.42, 95% CI -0.68 to -0.17, P = 0.001).
Conclusions: Available evidence did not support the use of music therapy to improve overall quality-of-life in palliative care. While this review suggests music therapy may be effective for reducing pain, this is based on studies with a high risk of bias. Further high quality research is required.

Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol

Aims. This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Background. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Study design. Musicinmindisamulti-centredsingle-blindrandomizedcontrolledtrial involving 200 young people (aged 8–16 years) and their parents. Eligible participants willhaveaworkingdiagnosiswithintheambitofInternational ClassificationofDisease 10 Mental and Behavioural Disorders and will be recruited over 15 months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collectedfromyoungpeopleandtheirparentsusingstandardizedoutcomemeasuresfor communicative and interaction skills (primary endpoint), self-esteem, social functioning, depressionandfamilyfunctioning.Follow-updatawillbecollected1and13 weeks afterthefinalmusictherapysession.Acost-effectivenessanalysiswillalsobecarriedout. Discussion. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in theISRCTNRegister,ISRCTN96352204. Ethical approval was gained in October 2010.

Music therapy for palliative care: A realist review

Music therapy has experienced a rising demand as an adjunct therapy for symptom management among palliative care patients. We conducted a realist review of the literature to develop a greater understanding of how music therapy might benefit palliative care patients and the contextual mechanisms that promote or inhibit its successful implementation.
We searched electronic databases (CINAHL, Embase, Medline, and PsychINFO) for literature containing information on music therapy for palliative care. In keeping with the realist approach, we examined all relevant literature to develop theories that could explain how music therapy works.
A total of 51 articles were included in the review. Music therapy was found to have a therapeutic effect on the physical, psychological, emotional, and spiritual suffering of palliative care patients. We also identified program mechanisms that help explain music therapy's therapeutic effects, along with facilitating contexts for implementation.
Music therapy may be an effective nonpharmacological approach to managing distressing symptoms in palliative care patients. The findings also suggest that group music therapy may be a cost-efficient and effective way to support staff caring for palliative care patients. We encourage others to continue developing the evidence base in order to expand our understanding of how music therapy works, with the aim of informing and improving the provision of music therapy for palliative care patients.

Research Protocol: A Randomized Controlled Trial of Functional Family Therapy: An Early Intervention Foundation (EIF) Partnership between Croydon Council and Queen's University Belfast

The paper presents a protocol for ‘A Randomized Controlled Trial of Functional Family Therapy (FFT): An Early Intervention Foundation (EIF) Partnership between Croydon Council and Queen's University Belfast’. The protocol describes a trial that uses FFT as an alternative intervention to current use of the youth justice system and local authority care with the aim of reducing crime/recidivism in young people referred to Croydon Council. The trial will take place over a period of 36 months and will involve up to 154 families. Croydon Council will employ a team of five Functional Family Therapists who will work with families to promote effective outcomes. The Centre for Effective Education at Queen’s University Belfast will act as independent evaluators of outcomes for families and young people. The work is supported from the United Kingdom Economic & Social Research Council/Early Intervention Foundation Grant Number ES/M006921/1.

The Association of Skin-Intrinsic Fluorescence With Type 1 Diabetes Complications in the DCCT/EDIC Study

OBJECTIVESTo determine whether skin-intrinsic fluorescence (SIF) is associated with long-term complications of type 1 diabetes (T1D) and, if so, whether it is independent of chronic glycemic exposure and previous intensive therapy.RESEARCH DESIGN AND METHODSWe studied 1,185 (92%) of 1,289 active Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) participants from 2010 to 2011. SIF was determined using a fluorescence spectrometer and related cross-sectionally to recently determined measures of retinopathy (stereo fundus photography), cardiac autonomic neuropathy (CAN; R-R interval), confirmed clinical neuropathy, nephropathy (albumin excretion rate [AER]), and coronary artery calcification (CAC).RESULTSOverall, moderately strong associations were seen with all complications, before adjustment for mean HbA1c over time, which rendered these associations nonsignificant with the exception of sustained AER >30 mg/24 h and CAC, which were largely unaffected by adjustment. However, when examined within the former DCCT treatment group, associations were generally weaker in the intensive group and nonsignificant after adjustment, while in the conventional group, associations remained significant for CAN, sustained AER >30 mg/24 h, and CAC even after mean HbA1c adjustment.CONCLUSIONSSIF is associated with T1D complications in DCCT\EDIC. Much of this association appears to be related to historical glycemic exposure, particularly in the previously intensively treated participants, in whom adjustment for HbA1c eliminates statistical significance.

Moving with Beats and Loops: The Structure of Auditory Events and Sensorimotor Timing

Traditionally, audio-motor timing processes have been understood as motor output from an internal clock, the speed of which is set by heard sound pulses. In contrast, this paper proposes a more ecologically-grounded approach, arguing that audio-motor processes are better characterized as performed actions on the perceived structure of auditory events. This position is explored in the context of auditory sensorimotor synchronization and continuation timing. Empirical research shows that the structure of sounds as auditory events can lead to marked differences in movement timing performance. The nature of these effects is discussed in the context of perceived action-relevance of auditory event structure. It is proposed that different forms of sound invite or support different patterns of sensorimotor timing. Hence, the temporal information in looped auditory signals is more than just the interval durations between onsets: all metronomes are not created equal. The potential implications for auditory guides in motor performance enhancement are also described.