Strategies to enhance treatment fidelity and music-based intervention reporting in dementia research

Abstract

Creative solutions are needed to address the well-being of the growing number of individuals living with dementia. Music-based interventions (MBIs) are promising and can be cost-effective; however, empirical evidence for MBIs is limited and published findings have not been widely translated into practice. Here, we describe how we implemented strategies to enhance rigor in a randomized clinical trial of an MBI for persons with dementia. We examined the impact of a singing-based MBI on feelings, emotions, and social engagement, relative to a non-music treatment (verbal discussion), delivered in small group format (25 minutes, 3 times/week for 2 weeks). We implemented National Institutes of Health Behavior Change Consortium strategies regarding: (i) design, (ii) interventionist training, (iii) treatment delivery, (iv) treatment receipt, and (v) treatment skills enactment. We applied the MBI Reporting Criteria including: (i) theoretical framework, (ii) musical content, (iii) dosage, (iv) interventionist, (v) treatment fidelity, (vi) setting, and (vii) delivery unit. We analyzed data with a separate linear mixed model for each dependent variable. 32 older adults with dementia (65–97 years) participated. The MBI yielded significant positive effects on all measured outcomes (all p’s < .05). Application of established guidelines enhanced methodological rigor and MBI reproducibility. To support translation of research into practice, clinicians should understand how to implement an MBI reported in research. Our study illustrates practical steps to address the need for improved MBI research in persons with dementia and can provide a model for others to enhance evidence-based practice with this population.

The current paper reports practical ways to enhance research rigor in music-based interventions with persons with dementia.

Implications.

Practice: Music-based interventions (MBIs) for persons with dementia may offer a cost-effective way to improve the psychosocial well-being of persons with dementia.

Policy: To enhance effective translation and appropriate application of MBIs for persons with dementia, researchers must provide a sufficient description of intervention components so that clinicians understand how to implement an MBI reported in research.

Research: Future research should examine MBIs in persons with dementia using science-driven principles to enhance rigor and reproducibility.

Introduction

The number of people living with Alzheimer’s disease and related dementias (ADRD) is growing proportionally to our aging population. As these persons experience declines in memory, communication, and thinking, they become increasingly dependent on others and require creative solutions to support their psychosocial needs [1]. However, many potentially helpful behavioral interventions are not implemented [2].

Many persons with ADRD retain the ability to respond to and engage in music experiences [3]. Numerous options exist for passive and active music-based interventions (MBIs), which have long been applied by music therapists and other practitioners in this population [4, 5]. MBIs may offer person-centered, cost-effective opportunities to manage symptoms, and support social-emotional well-being [3, 6–8]. However, empirical support for the use and appropriate application of MBIs in this population is very limited [3, 7, 9].

The National Institutes of Health (NIH) Sound Health initiative aims to expand research on MBIs for neurological disorders [7], among other goals [10]. “Even with decades of practical application, we do not fully understand how music and music therapy achieve … beneficial effects, or how to optimize them for the individual patient. We now have the opportunity to connect our rapidly increasing insights from neuroscience with the clinical experience of applying music therapy in practice” ([10], p. 2470). Nonetheless, it is important to note trends concerning the translation of research into clinical practice [2, 11]. While the field has shifted towards an evidence-based practice paradigm (i.e. integration of clinical wisdom, patient needs, and research), many MBI practitioners do not conduct, engage in, or view research as relevant to inform practice [11].

To identify mechanisms that underlie MBIs, enhance treatment fidelity, and improve communication with practitioners, researchers must provide sufficient description of intervention components [2, 12, 13]. “Music” within an MBI is complex. Depending on the goal, patient, and practice approach, it can involve a wide variety of styles (e.g. country, rock), selections (e.g. music from the patient’s formative years; recordings prescribed to all patients), format (e.g. live, recorded, interactive, passive), materials, and actions (e.g. singing, playing, moving, listening, creating) [5, 12]. Improved articulation of the MBI will help reveal key principles of the intervention and facilitate translation of reported research into practice [7, 12].

The NIH Behavior Change Consortium (NIH-BCC) has recommended quality assurance strategies related to: (i) design, (ii) interventionist training, (iii) treatment delivery, (iv) treatment receipt, and (v) enactment of treatment skills. These strategies are intended to promote methodological rigor, treatment fidelity, and research translation [13]. The MBI Reporting Criteria, designed to guide transparent and complete reporting, complement the NIH-BCC strategies and include: (i) theoretical framework, (ii) musical content, (iii) dosage, (iv) interventionist, (v) treatment fidelity, (vi) setting, and (vii) unit of delivery [12]. Combining these guidelines will enhance methodological rigor and articulation of the MBI to improve translation. Here, we describe how we applied these guidelines in a multi-site study with persons with ADRD [8, 14] as an example for other MBI researchers (refer to Table 1). We begin with a brief study overview (complete description in [8, 14]).

Table 1.

Treatment fidelity strategies and their implementation in this music-based intervention trial

Fidelity goal	How we applied the goal
Design Ensure consistent dosage Plan for setbacks	✓ Use the MBI Reporting Criteria ✓ Protocol: 6 sessions 3×/week 25-minute each for 2 weeks ✓ Facilities do not offer study activities ✓ Manual provided to study personnel during training ✓ Dosage monitored through pre/post-session notes ✓ Reminder signage for facility staff and participants ✓ Quality assurance audits with a protocol checklist ✓ Multiple interventionists trained ✓ Open communication between facility, interventionists, and study team
Interventionist Training Standardize training Ensure skill acquisition Minimize skill drift Accommodate differences	✓ Qualifications: MT-BC credentials, >1 year experience with population ✓ Piloted and validated all training procedures with independent expert ✓ Consistent training modules for all study personnel ✓ Knowledge assessed through quizzes ✓ Skills assessed through mock sessions ✓ Weekly supervision check-in with PI, available as needed ✓ Pre/post-session notes required skill reflection ✓ Protocol checklist for quality assurance audits ✓ Completed identical training but at own pace and with feedback ✓ Weekly debriefing with PI ✓ Individualized supervision and monitoring
Treatment Delivery Control for provider differences Reduce differences within treatment Ensure adherence to treatment protocol Minimize contamination between conditions	✓ Interventionists selected for specific characteristics ✓ Interventionists delivered both treatments ✓ Independent quality assurance evaluator ✓ Used intervention and research protocols ✓ Pre/post-session notes prompted self-quality assurance monitoring ✓ Independent quality assurance evaluator ✓ Use the MBI Reporting Criteria ✓ Pre/post-session checklist of key protocol elements ✓ Interventionists could readily report protocol deviations ✓ Sites (not individuals) randomly assigned to treatment order ✓ Visual aids were treatment specific ✓ Training materials highlight differences between treatments ✓ Interventionists trained on theoretical framework ✓ Study personnel trained to address questions in lay language
Treatment Receipt Ensure participant comprehension Ensure participants can use cognitive skills Ensure participants can perform behavioral skills	✓ Interventionists used behavioral observation, age-appropriate visual aids ✓ Standardized documentation of participant involvement ✓ Interventionists summarized participant responses in structured session note ✓ Interventionists used behavioral observation, age-appropriate visual aids ✓ Interventionists summarized participant responses in structured session note

Informed by reporting guidelines for music-based interventions [12] and NIH Behavior Change Consortium strategies [13].

Methods

MBI trial overview

The Institutional Review Board at the University of Iowa approved this randomized crossover study with 32 participants with ADRD [65–97 years, 80% women, 100% white; per Clinical Dementia Rating [15] mild (i) n = 4, moderate (ii) n = 15, severe (iii) n = 13] at three care facilities (a priori power analysis, α = 0.05, two-tailed; δ = 0.80; detailed description and limitations of this sample discussed in [8, 14]). We examined the effects of a live MBI on feelings (i.e. self-reported subjective states [16]; Dementia Mood Picture Test, designed for and validated with persons with moderate to severe dementia [17]), emotions (i.e. observable patterns that indicate specific states; Observed Emotion Rating Scale [18]), and social engagement (Menorah Park Engagement Scale [19]; complete description of outcome measurement in [8, 14]). We compared two treatments: small group singing adapted for maximal participation (as is typical in music therapy [4, 5, 20, 21]); and a non-music verbal discussion activity that included structured social interaction. Both treatments had the same dosage and used the same implementation principles except for the presence of music (details in [8, 14]).

We hypothesized that the MBI would offer multiple means to engage and interact and predicted that it would result in more social engagement than the non-music verbal discussion condition. We hypothesized that the familiar and preferred music within the MBI would be more emotionally evocative than conversing about familiar and preferred topics and predicted that the MBI would result in more improved feelings and positive emotions than the non-music comparison. In support of our hypotheses, the MBI yielded significant positive effects on all measured outcomes (separate linear mixed model for each dependent variable; feelings: music > verbal, t = 2.09, P = .0381, β = 6.18; emotions (pleasure): music > verbal, t = 5.49, P < .0001, β = 13.94; social engagement: music > verbal, t = 4.82, P < .0001, β = 16.73; complete analysis and results in [8, 14]).

In addition to complex factors related to characteristics of the participants and their care environment, the MBI involved three interventionists, six data takers, live music, and music implementation. In the next sections, we report on the NIH-BCC strategies used to enhance methodological rigor [13] and describe how the MBI Reporting Criteria can be utilized within the NIH-BCC framework to guide transparent and complete reporting of an MBI [12].

Strategies related to the study design

The NIH-BCC recommends that behavioral researchers take steps to ensure consistent dosage and to plan for setbacks [13]. Similarly, MBI session quantity, duration, and frequency must be clearly reported [12]. In our study (refer to Table 1), the dosage within each condition involved 25-minute sessions in a small group format (3–5 participants per group) three times per week for 2 weeks. Once a facility enrolled, we prepared a schedule that aligned with facility and study personnel availability and accounted for holidays to ensure minimal to no disruption to dosage. The facilities did not offer either activity to their residents with dementia to avoid “double dosing” our participants and contaminate results. On session days, we provided individualized reminder signage for care staff to support session attendance. This MBI was designed to be led by a credentialed music therapist (i.e. MT-BC [20, 21]), and we utilized live data takers during sessions. To plan for setbacks such as personnel turnover and illness, we trained multiple interventionists and data takers on all study roles. Open communication with facility and study personnel regarding the importance of maintaining a schedule and a decision-tree for last-minute schedule changes also facilitated consistent dosage. Furthermore, we piloted all study procedures, trainings, and materials to ensure design feasibility [14].

Strategies related to the interventionist

The NIH-BCC recommends planning and implementing consistent training that can accommodate differences between interventionists. Once training is complete, it is important to assess skill acquisition and minimize skill drift [13]. In addition, we collected information regarding training and qualifications [8, 14], as music expertise, clinical skills, and therapeutic strategies vary greatly across professions and should be reported to facilitate translation [2, 7, 12]. Our study included three board-certified music therapists with at least one year of post-internship experience with persons with dementia (n.b., in the USA, board-certified music therapists receive 1200+ hours supervised clinical training [20, 21]). To account for differences in expertise and approach and promote protocol adherence, all interventionists completed systematic protocol training (validated by independent experts and piloted [14]). Training consisted of self-study with written quizzes to ensure knowledge acquisition, independent MBI preparation, and a practice session with supervision feedback. To minimize drift, interventionists completed weekly check-ins with Author 1, a pre-session checklist of implementation reminders, and a structured post-session field note. Rather than rigid rules (impractical with live MBIs), interventionists followed implementation guidelines to facilitate similar delivery. These strategies and materials that are developed and used successfully in research could be readily used to facilitate implementation in real-world practice [2].

Strategies regarding treatment delivery

The MBI in our study was informed by Author 1’s clinical experience and existing research, and it was validated by independent experts as something reflective of real-world practice [14]. To evaluate the effectiveness of an MBI, it is crucial to ensure that it is delivered as intended [12] and develop strategies to facilitate protocol adherence and minimize contamination between conditions [13]. As indicated in Table 1, interventionists were not informed of study aims or hypotheses. They were instructed to engage participants to their full potential and support their safe and successful participation in the group, regardless of study condition. Interventionists strived to maintain a consistent environment and group arrangement across all sessions at a facility (e.g. same room, time, manner of interaction, visual aids, lighting) to isolate effects of the music.

All study personnel received a protocol manual. Although such guidelines may seem restrictive to MBI practitioners who emphasize creativity and momentary clinical decision-making, it helps ensure treatment fidelity and informs decision-making during treatment [13]. Such steps are important with MBIs, as even those that use recorded music and passive listening are complex [12]. A protocol facilitates systematic examination and articulation of possible mechanisms that underlie MBI effectiveness (as in [8, 14]), which helps practitioners understand key ingredients to apply in practice [2, 12, 13].

Training materials highlighted differences between conditions and emphasized that the comparison condition should be devoid of music, music references, and musical cues. Interventionists completed a pre-session checklist to remind them of session content and key protocol elements and a post-session note to describe how they implemented these components. Bellg and colleagues [13] recommend assessing participants’ perceptions of interventionist qualities; however, given the participants’ degree of cognitive decline, we were unable to do so reliably. Instead, an independent quality assurance monitor attended one MBI session and one comparison session per interventionist and confirmed protocol adherence (100% treatment fidelity). In addition, the post-session note prompted self-reflective quality assurance monitoring.

Strategies for delivering MBIs

Several MBI Reporting Criteria relate to treatment delivery: (i) theoretical foundation (including rationales for music selection and delivery mode), (ii) details to enable replication, (iii) procedures for individualization (including what music and how it was delivered), (iv) who selected the music, (v) intervention strategies and materials, and (vi) setting (including ambient sound and privacy) [12]. Our study was grounded in the Clinical Practice Model for Persons with Dementia, a theoretical model that is based on research and clinical wisdom and holistically considers strengths and needs of the individual. It informs the design and implementation of behavioral interventions (including MBIs) within a schema regarding why particular strategies are important and how to implement them within a schema of six interrelated areas [22] (i.e. implementation principles). Briefly, these strategies are: Cognition (compensate for declines in declarative memory and processing speed), Attention (promote interest and motivation while minimizing distraction), Familiarity (enhance recognizability of stimuli), Audibility (given the likelihood of some hearing loss, facilitate auditory perception, e.g. careful arrangement of pitch range; multiple means of representation; refer to [22, 23] for extensive guidance), Structure (offer redundant structure and predictability), and Autonomy (offer choice and opportunity for self-efficacy, matched to capabilities) [2, 7, 24]. In conjunction with our protocol, this model enables replication and individualization. The singing-based intervention involved live, participant-preferred songs accompanied by acoustic guitar, comprising 85% interactive singing and 15% discussion and commentary. Participants had diverse music preferences, including popular standards, country, and sing-along songs (e.g. You are My Sunshine), and only two had a history of formal music training. To isolate the effects of music, the comparison condition centered around themed discussions (including topics personally relevant to participants) and trivia without any musical elements. Each condition was presented in groups of three to five for 25 minutes in the afternoon in a consistent location at the participants’ care facilities, three times per week for two consecutive weeks. Extensive details regarding the conditions are reported in other publications [8, 14, 22].

Strategies to support treatment receipt and enactment of treatment skills

These NIH-BCC recommendations shift the focus from the interventionist to the person with dementia. To confirm treatment receipt, the participant must demonstrate that they are experiencing the delivered intervention so that it has a chance to elicit the desired effect [13]. Following the Clinical Practice Model, interventionists ensured that participants could engage as much as they were able to and desired by implementing strategies to compensate for memory deficits and processing speed, enhance motivation, minimize distractions, and facilitate stimuli recognizability and auditory perception. They offered redundant structure and predictability, as well as choice and opportunity for self-efficacy, according to their capabilities [22]. Interventionists used behavioral observation to monitor safety (e.g. wandering, agitation) and assess participants’ behaviors for treatment receipt (e.g. toe tapping to music; mouthing song lyrics; alerting and arousal responses). They documented participants’ responses to the MBI and the comparison condition, noting potential external influences (e.g. care staff chatting in the vicinity). As an extension of treatment receipt, treatment enactment regards “…the extent to which a patient actually implements a specific behavioral skill, cognitive strategy, or motivational state at the appropriate time and setting in his or her daily life” ([13], p. 449). Enactment is perhaps a futile goal for persons with significant declarative memory impairment. Rather, the relationship between MBI strategies and behavioral responses within-sessions (i.e. treatment receipt) may be conceptualized as mechanisms by which longer-term treatment effectiveness may occur (e.g. reduced behavioral symptoms, improved mood, as in [8, 9, 14, 24]).

Discussion

We took steps to address the need for improved MBI research with persons with ADRD [3, 7, 9] by following recommendations from the NIH-BCC [13] and MBI Reporting Criteria [12]. This study involved complex characteristics of the MBI and target population (i.e. ADRD), a compelling reason to follow such guidelines. Combining these guidelines strengthened methodological rigor, enhanced the reliability and validity of our findings, and facilitated our ability to consider possible mechanisms that underlie the MBI.

To support translation of research into practice—which can vary greatly from one care setting to another—clinicians must understand how to implement an MBI reported in research, key principles, and why they are important [2, 7, 12]. A holistic approach that emphasizes treatment fidelity and articulation of principles and also incorporates testable hypotheses that are generated from observations in the field (i.e. reverse translation) may lead to research that clinicians find more useful and facilitate practical translation of research into practice [2, 24, 25]. Specific recommendations for clinicians are to record details of MBIs that are used in the field following the MBI Reporting Criteria and to seek partnership with researchers to systematically examine interventions informed by clinical wisdom while adhering to NIH-BCC strategies. The relatively new NIH Stage Model of behavioral intervention development emphasizes the importance of identifying and examining mechanisms at every stage so that an intervention can be flexibly implemented to maximum potency and treatment fidelity across various settings by different practitioners [2, 18]. “In this model basic researchers, intervention developers, and community-oriented intervention and implementation researchers all have a significant role to play in every stage of developing potent and implementable interventions” ([18], para. 4). Through bidirectional flow of knowledge and exchange of ideas, we can empower clinicians to be more involved in research, advance evidence-based practice, and address the great public health need of families living with dementia.

Conflict of interest statement. Alaine E. Reschke-Hernández and Daniel Tranel declare that they have no conflicts of interest.

Funding

This study was funded by Dr. Richard and Ms. Ellen Caplan (to ARH); the University of Iowa Office of Outreach and Engagement (to ARH); the University of Iowa Music Therapy Area (to ARH); the University of Iowa GOLDRush crowdfunding campaign (to ARH); the National Institute of Mental Health (P50 MH094258 to DT); and the Kiwanis Neuroscience Research Foundation (to DT). Based on the dissertation completed by Reschke-Hernández [14].

Human Rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Welfare of Animals

This article does not contain any studies with animals performed by any of the authors.

Study Registration

This study was pre-registered at ClinicalTrials.gov Identifier NCT03643003.

Analytic Plan Pre-registration

The analysis plan was not formally pre-registered.

Data Availability

De-identified data from this study are not available in a public archive. De-identified data from this study will be made available (as allowable according to institutional IRB standards) by emailing the corresponding author.

Analytic Code Availability

Analytic code used to conduct the analyses presented in this study are not available in a public archive. They may be available by emailing the corresponding author.

Materials Availability

Materials used to conduct the study are not publicly available. They may be available by emailing the corresponding author.