Jakob et al.

BMC Psychiatry (2024) 24:230 BMC Psychiatry

https://doi.org/10.1186/s12888-024-05697-0

STUDY PROTOCOL Open Access

Study protocol: randomized controlled

trial of an individualized music intervention
for people with dementia in the home care
setting
Elisabeth Jakob1*, Juliane Meininger1, Mareike Hillebrand1, Lisette Weise1 and Gabriele Wilz1

Abstract
Background Studies suggest that individualized music listening is an effective, non-pharmacological intervention
for improving the quality of life of people with dementia in the institutional care setting. Noting that most people
with dementia live at home, we conduct a randomized controlled trial to assess the feasibility and effectiveness
of an app-based individualized music listening intervention for people with dementia in the home care setting. The
intervention is delivered by family caregivers.
Methods We will recruit N = 130 dyads consisting of one person with dementia living at home and their family
caregiver. After a baseline assessment, dyads are randomly assigned by gender to either the intervention or control
group. People with dementia in the intervention group listen to individualized music playlists for 20 min every other
day for six weeks via the self-developed Individualized Music and Dementia app. The control group receives standard
care. All dyads complete paper-and-pencil questionnaires six weeks before the start of the intervention (T0), directly
before the intervention (T1), directly after the intervention (T2), and six weeks later (T3). During the intervention
period, all caregivers also complete daily ecological momentary assessments via the app. During three home visits,
a trained project member will observe the dyads and collect hair samples. After the intervention, semi-structured
interviews will be conducted to collect information about participants’ experiences with the app and intervention.
The primary outcome is the attainment of individual goals established during the baseline assessment. Secondary
outcomes are the well-being, physiological stress and quality of life of people with dementia and their caregivers;
people with dementia’s behavioural and psychological symptoms of dementia, resistance during care, and reac-
tions to the music; caregivers’ burden of care, positive aspects of care, and caregiving self-efficacy; and the quality
of the caregiver-care recipient interaction.
Discussion Our study will assess the extent to which an app-based individualized music listening intervention is fea-
sible and effective for enhancing the well-being and quality of life of people with dementia living at home and their
family caregivers.
Trial registration German Clinical Trials Register DRKS00025502 and ISRCTN registry ISRCTN68084105, https://​doi.​
org/​10.​1186/​ISRCT​N6808​4105

*Correspondence:
Elisabeth Jakob
[email protected]
Full list of author information is available at the end of the article

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 2 of 10

Keywords Non-pharmacological intervention, Receptive music therapy, Alzheimer’s disease, Behavioural and
psychological symptoms of dementia, Neuropsychiatric symptoms, Quality of life, Family caregivers

Background homes). Thus, the feasibility and effectiveness of IML

Around 55 million people worldwide are currently living interventions in the home care setting is uncertain. Dif-
with dementia, and this number is expected to dramati- ferences in, for instance, the characteristics of the care
cally increase in the future as populations grow older [1]. recipients (e.g., dementia severity) or the physical living
People with dementia increasingly need assistance and space of private and institutional settings (e.g., com-
support as their disease progresses. Most people with fort, available distractions) may affect the feasibility
dementia live at home, and care is most often provided by and effectiveness of IML interventions. Nevertheless,
a family member or other informal caregiver [2, 3]. There a handful of quasi-experimental studies provide first
is thus an urgent need for interventions – especially non- evidence that IML delivered in the home care setting
pharmacological interventions [4, 5] – that improve the effectively reduce distress [19, 20], agitation [21] and
quality of life of people with dementia and their caregiv- pain levels [22] among people with dementia. There is
ers that can also feasibly be implemented in the home also some evidence that home-based IML interventions
care setting. A particularly important target for inter- benefit caregivers by increasing caregiver self-efficacy
vention is decreasing the behavioural and psychological [19] or providing caregivers with an opportunity to take
symptoms of dementia (BPSD) such as agitation, anxiety a break [20].
or depressive symptoms, which significantly reduce the Building on existing evidence of the effectiveness of
well-being and quality of life of people with dementia [6] IML in the institutional and, to a much lesser extent,
and their caregivers [7, 8], as well as negatively impact the home care setting, we conduct the first RCT to test
the quality of interactions between the caregiver and care the feasibility and effectiveness of a self-developed,
recipient [9, 10]. app-based IML intervention for people with dementia
Individualized music listening (IML) – that is, listen- living at home. The intervention is delivered by fam-
ing to personally-meaningful music based on one’s own ily caregivers in the people with dementia’s own home
preferences and experiences – has been shown to be an environment. Most existing studies have relied on pro-
effective non-pharmacological intervention for enhanc- fessional caregivers and/or music therapists to imple-
ing the quality of life of people with dementia in the insti- ment the IML intervention. Designing interventions
tutional care setting [11]. The use of IML interventions that can be delivered by family caregivers is key to mak-
is supported by neuroscientific evidence, which shows ing it possible to implement IML interventions on a
that the brain regions associated with long-term musical wider scale. First evidence suggests that family caregiv-
memory are relatively unaffected by dementia [12]. Thus, ers can indeed successfully deliver IML interventions in
people with dementia remember personally-meaningful the home care setting [23], although the intervention
music very well. Although the precise mechanisms are must be adapted to the caregivers’ technological skills
still unclear, recent reviews of studies conducted in the and experience [19, 20].
institutional care setting have concluded that IML inter- We expect that our app-based IML intervention can
ventions have considerable potential for improving the provide a cost-effective, highly acceptable intervention
well-being, social behaviour and BPSD (particularly agi- to improve the quality of life and well-being of people
tation) of people with dementia [13–16]. A very recent with dementia and their caregivers. Previous research
randomized controlled trial (RCT) showed that IML has indicated high heterogeneity in how people with
reduced agitation, aggression, and disorientation [17], dementia react to IML [24]. We therefore focus on
and helped people with dementia accomplish their own, individual goal attainment as our primary outcome.
individual goals (e.g., regarding the people with demen- We additionally examine the effects of the intervention
tia’s social participation and/or mood) [18]. However, on caregivers and people with dementia’s well-being,
reviews have also emphasized that the effects of IML BPSD, the caregiving experience, and the quality of car-
interventions are highly heterogeneous across studies, egiver-care recipient interactions.
and more methodologically rigorous studies and large- We also add to the literature by investigating the
scale RCTs are urgently needed [13–16]. impact of IML on the physiological stress of caregiv-
A further caveat in research on IML is that the vast ers and people with dementia. Although it is plausible
majority of research on IML interventions has taken that IML benefits people with dementia at least partly
place in the institutional care setting (e.g., nursing by reducing physiological stress, so far few empirical

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 3 of 10

studies have examined how IML impacts indicators cooperation partners (e.g., medical practices; the Ger-
of physiological stress (e.g., heart rate, blood pres- man Alzheimer Society of Thuringia), we will recruit
sure). Moreover, most existing studies have focused participants via posters and flyers; online, print and
exclusively on immediate and short-term effects [24]. radio media; and project presentations at planned events
Existing evidence has been somewhat mixed, with and support groups for caregivers. Interested caregivers
preliminary findings suggesting potential autonomic can contact the project team by telephone during office
down-regulation following IML in the short-term (for a hours, personally at project presentations, via the contact
review, see Sittler et al., [25]). In our study, we examine form on the project website at www.​musik-​demenz.​de,
the short- and longer-term impact of IML on heart rate or by e-mail. Potential participants will receive detailed
variability and, for the first time, cortisol levels in hair. information about the study. After checking that the
Analysing cortisol in the hair of people with dementia inclusion criteria have been met, the research team will
is feasible and also has a number of advantages in prag- mail potential participants written information about the
matic RCTs [26], and offers a promising methodologi- study and data protection, a consent form and a stamped
cal approach for investigating the longer-term effects of return envelope. The text will be formulated for caregiv-
IML on physiological stress [26]. ers and in simple language for people with dementia.
Dyads who have given informed consent form will be
Methods included in the study.
Design
We conduct an RCT with an intervention and a con- Sample size
trol group. All participants complete paper-and-pencil Based on prior research on the effects of IML on people
questionnaires at four assessment points: baseline (T0; with dementia in the institutional care setting [18, 24,
six weeks before the intervention), pre-test (T1; imme- 27], we expect that IML will have small to medium effect
diately before the intervention), post-test (T2; immedi- sizes (f = 0.2) on our outcome variables. Given our two-
ately after the intervention) and follow-up (T3; six weeks group design, an α of 0.05, and a power (1 − β) of 0.95, a
after the intervention). During the six-week intervention sample of N = 98 dyads will be needed in order to reliably
period, all caregivers additionally complete daily assess- detect effects. Drop out in studies with a similar target
ments (i.e., ecological momentary assessments) and three group has ranged from 18% [18] to 36% [28]. To account
home visits take place. During the home visits, a project for drop out, we therefore aim to recruit N = 130 dyads.
member conducts behavioural observations and collects
hair samples. Provided consent, video recordings will be Procedure
made. At the last home visit, a project member conducts Baseline assessment
semi-structured interviews. Figure 1 provides an over- All caregivers will receive a paper-and-pencil question-
view of the design. naire per mail with a stamped return envelope. The ques-
tionnaire will assess sociodemographic and other control
Participants variables (e.g., sleep quality, physical complaints), as well
The RCT is based on dyads consisting of one person with as the caregiver’s well-being and perceptions of the car-
dementia living at home and their family caregiver. To egiving experience. Caregivers will also provide infor-
participate in the study, the person with dementia must mation about their perceptions of the well-being and
have medically-diagnosed dementia, be living at home, BPSD of the person with dementia, and the quality of the
and have a health care proxy. Exclusion criteria for peo- caregiver-care recipient interactions. A research assis-
ple with dementia are severe hearing impairment or tant will contact the caregiver by telephone to debrief
planning to move to the institutional care setting within the completed questionnaire and ask caregivers about
the next three months. No restriction is made regard- depressive symptoms of the person with dementia. Car-
ing the age of the participating people with dementia. egivers will also be asked to formulate at least one goal
Exclusion criteria for caregivers are major physical health for the person with dementia to accomplish during the
impairments or progressive illness, psychiatric diagno- six-week intervention period. Caregivers will describe
sis, obvious cognitive impairment, difficulty understand- observable criteria by which accomplishment of the goal
ing German, or participation in another study involving can be determined.
caregivers.
Randomization
Recruitment Following the baseline assessment, a research assistant
Dyads will be mainly recruited in Thuringia and adja- uninvolved in the assessments or implementation of
cent regions in Germany. With the assistance of regional the study will use a computer-generated randomization

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 4 of 10

Fig. 1 Overview of the design of the study

list from www.​random.​org to randomly assign partici- schedule a first home visit. It will not be possible to blind
pants by gender to either the intervention (IG) or control participants to their treatment allocation due to the
group (CG). A research assistant will contact the dyads nature of the intervention.
by telephone to inform them about their allocation and

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 5 of 10

The individualized music and dementia app Home visits

All dyads will receive a tablet (Samsung Galaxy Tab During the six-week intervention period, two project
A8) pre-installed with the self-developed Individual- members will conduct a total of three home visits per
ized Music and Dementia (IMuD) app. We designed the dyad. The home visits will take place in the first, third or
IMuD-App to be exceptionally user-friendly (e.g., large fourth (depending on the dyad’s availability) and sixth
font, explanations in simple language, intuitive naviga- week of the intervention period. The dyads will receive
tion). The IML intervention is delivered via the app. All informational brochures on dementia during each home
caregivers will additionally use the app to complete and visit.
submit daily assessments as described below. Throughout During the first home visit, caregivers in the CG will
the intervention, caregivers can also use the app to con- receive the same tablet as caregivers in the IG. The pro-
tact the research team using a contact form. ject member will provide the caregiver with a detailed
technical briefing of the app and an introduction to the
daily assessments. Together with the project member,
Intervention caregivers in the IG will additionally watch instructional
After randomisation, the tablet will be sent to partici- videos via the app regarding how to conduct the music
pants of the IG via mail. Caregivers in the IG will com- listening sessions.
plete an assessment of music that is personally-relevant The project member will then use the Mini-Mental-
to the person with dementia. The assessment includes State-Examination (MMSE) [29] to assess the severity
open question (e.g. “Which songs were heard at family of dementia of the care recipient. If the MMSE score
celebrations?”), multiple-choice questions (e.g. regard- exceeds 10, the project member will use the Subjective
ing the preferred genre) and, based on a search of pop- Quality of Life Inventory [30] to assess the person with
ular music from different decades, a list of examples of dementia’s ability to make statements about their own
popular artists and song titles. To the extent possible, the well-being.
assessment will be completed together with the person During each home visit, a trained project member will
with dementia. The caregiver will submit the completed use a revised version of the Dementia Coding System
assessment via the app. Based on the completed assess- (DeCS) [17] to record the reactions and behaviours of the
ment, the project team will create three individualized person with dementia. The coding system was adapted
music playlists for each person with dementia in the IG. for the current project and includes 26 items covering the
People with dementia in the IG will then listen to their people with dementia’s emotional, physical, and commu-
individualized playlists for 20 min every other day (3–4 nicative behaviour (e.g., facial expressions, gestures, body
times a week) for six weeks, through headphones if pos- movement). A trained research assistant will use the
sible. Dyads can choose when the sessions take place and DeCs to assess the behaviour of the person with demen-
skip a session if necessary. The caregiver and/or person tia in 15 time-units of four minutes each (60 min in
with dementia can freely choose one of the three music total). For participants in the IG, the project member will
playlists which are stored on and played through the app. record the behaviour of the person with dementia 20 min
The caregiver will be supported to find out what accom- before, 20 min during, and 20 min after the listening ses-
paniment the person with dementia needs when listen- sion. For participants in the CG, the project member will
ing to the music. Videos and written recommendations record the behaviour of the person with dementia during
in the app provide guidance on how the caregiver can a 60-min open conversation.
optimize the listening situation, interact with the person Provided consent, the behavioural observations will be
with dementia during the listening sessions, and respond filmed. One camera will record the face of the caregiver,
to any challenging situations (e.g., lower the volume or a second camera will record the face of the person with
change the song if the person with dementia becomes dementia, and a third camera will record a 360° view of
agitated). the room. As described below, the videos will be analysed
Participants in the CG will receive no IML interven- for indications of (acute) physiological stress, reactions to
tion and organize their everyday life as usual. Members the music and dyadic interactions at a later time point.
of the CG will receive 200 Euro at the end of successful Provided consent, the research team will addition-
participation in the study. The renumeration is provided ally collect hair samples from the person with dementia
to the dyad as a unit. Dyads of the IG will receive no and the caregiver during the first and third home visits.
renumeration. As described below, the hair samples will be analysed for
The project team will contact participants in both the indications of chronic physiological stress.
IG and the CG regularly in order to encourage continued During the third home visit, a project member will con-
participation and address any arising problems. duct a semi-structured interview to capture participants’

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 6 of 10

experiences with the tablet, app, daily assessments, home interview were attained will be quantified using a 5-point
visits and project team. Caregivers in the IG will also scale (-2 = “severe deterioration”; + 2 = “complete goal
be asked to describe their perceptions of the feasibility, attainment”; [32]).
acceptance, applicability, and effects of the IML interven-
tion. To the extent possible, the participants with demen-
tia will be asked to describe their own experiences. Well‑being of person with dementia: self and caregiver
The research team will collect the tablets and further perceptions
technology at the end of the third home visit. Based on the circumplex model of emotion [33], car-
egivers will use visual analogue scales ranging from 0 to
App‑based daily assessments 100 [34] to assess the person with dementia’s emotional
During the six-week intervention period, all caregivers well-being and arousal daily via the app and as part of the
will use the app to complete daily ecological momen- paper-and-pencil questionnaires assessments at T0, T1,
tary assessments of their own well-being and arousal, the T2, and T3.
well-being and arousal of the people with dementia and To the extent possible, participants with dementia will
the caregiver-care recipient interaction. At a time of the provide self-reports of their well-being and quality of
caregivers’ choosing, the app will prompt the caregiver life. During each of the three home visits, participants
to complete the questionnaire with an audible beep. Car- with dementia will use the Dementia Mood Picture Test
egivers can skip an assessment if they do not have time [35] to self-assess their emotional well-being by select-
on a day. ing which of six faces (bad mood, angry, sad, worried,
good mood, happy) best represents their emotional state.
Questionnaire assessments Participants with dementia will also use the Heidelberg
In addition to the app-based daily assessments and the Instrument for the Quality of Life of Dementia Patients
home visits, paper-and-pencil questionnaires will be [36] to indicate their overall life satisfaction (1 = “not at
sent to the participants by mail directly before the inter- all satisfied” to 4 = “very satisfied”).
vention (T1), directly after the intervention (T2), and
six weeks later (T3). All questionnaire assessments are
identical. Behavioural and psychological symptoms of dementia
Caregivers will assess the person with dementia’s BPSD
Adverse events as part of the paper-and-pencil questionnaires assess-
Caregivers will be supported to find out what accompa- ments at T0, T1, T2, and T3. Caregivers will use the
niment the person with dementia needs when listening German-version of the Behavioural Pathology in Alzhei-
to music. Caregivers should remain present during the mer’s Disease Rating Scale [25]. Caregivers use a dichoto-
first IML sessions to be able to intervene if necessary. To mous response scale (0 = “not present”, 1 = “present”) to
empower the caregivers, project members will personally indicate the extent to which the people with dementia
provide a detailed introduction to the technology and the displays each of 23 BPSD covering four factors (Para-
IML intervention. If the person with dementia repeatedly noid and Aggressiveness, Hallucinations and Agitation,
reacts negatively to the music, it is possible to change the Affective Disturbances, Anxieties and Phobia). Caregiv-
song permanently, lower the volume, pause or stop the ers will additionally use the Cornell Scale for Depression
music. Participants can stop a listening session or drop in Dementia [37] to assess the people with dementia’s
out of the study at any time. depressive symptoms. Specifically, caregivers are asked
to indicate the extent to which the person with demen-
Outcome measures tia has each of 19 symptoms of depression using four
An overview of the assessments and outcome variables is answer categories (0 = “absent”, 1 = “mild/intermittent”,
provided in additional file 1. 2 = “severe”, 3 = “assessment not possible”). Caregivers
will also use a visual analogue scale ranging from 0 to
Primary outcome: individual goal attainment 100 to assess the people with dementia’s resistance during
Standardized outcome measures may underestimate the care [38].
effects of IML. We therefore focus on participants’ indi- During the home visits, a trained project member
vidual goal attainment after six weeks of IML or treat- will also use the revised version of DeCS [17] to assess
ment as usual as the primary outcome. We will use the the person with dementia’s BPSD as part of the behav-
Goal Attainment Scaling (GAS) approach to assess indi- ioural observations. A subset of 14 of the 26 behaviours
vidual goal attainment [31]. The extent to which the assessed by the revised DeCS are BPSD (e.g., resistance/
individual goals formulated during the T0 telephone refusal behaviours).

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 7 of 10

Caregiver’s well‑being After each home visit, a project member will answer
Caregivers will assess their emotional well-being and a single item on the dyad’s global relationship qual-
arousal daily via the app (daily assessments as well as ity (-2 = “very bad” to + 2 = “very good”). The project
directly before and after IML) and as part of the pencil- member will also complete a self-constructed relation-
and-paper assessments at T0, T1, T2, and T3. Caregivers ship quality questionnaire (16 items; e.g., “They get
use visual analogue scales ranging from 0 to 100 [34]. along well with each other”; -2 = “completely disagree”
to + 2 = “completely agree”, or “assessment not possible”).
The caregiving experience Trained raters will additionally use videos of the home
Caregivers will assess the caregiving experience as part of visits to assess the quality of the dyadic interaction. Three
the paper-and-pencil questionnaires at T0, T1, T2, and camera recordings are made: frontal view of the person
T3. To assess caregiving burden, caregivers will complete with dementia, frontal view of the caregiver and record-
the German short version of the Home Care Scale (10 ing of the overall setting.
items, 0 = “exactly correct” to 3 = “not correct”; [39]). To
assess positive aspects of caregiving, caregivers complete Acute and chronic physiological stress
a German version of the Positive Aspects of Care Ques- We will use videos of the home visits and FaceReader
tionnaire (6 items; 0 = “strongly disagree” to 4 = “strongly software (Noldus) to assess the heart rate variability of
agree”; [40]). The German version of the questionnaire is the person with dementia and the caregiver as an indi-
currently being validated. To assess caregivers’ caregiv- cator of acute physiological stress before, during, and
ing self-efficacy, caregivers will complete the Satisfaction shortly after IML (immediate and short-term effects) [26,
with One’s Own Performance as a Caregiver subscale of 44]. FaceReader uses photoplethysmography to detect
the abbreviated Sense of Competence Questionnaire (5 heart rate in video recordings of faces [45]. We will use
items, 0 = “does not apply” to 5 = “applies”; [41]). the cortisol/dehydroepiandrosterone concentrations in the
hair samples collected in the first and third home visits
Immediate reactions to individualized music listening as an indicator of chronic physiological stress before and
Directly before and after IML, participants with demen- after six weeks of IML (i.e., longer-term effects) [26, 46].
tia in the IG group will use the Smiley Assessment Scale
(SAS) to assess their current mood via the app. Partici- Intervention experiences, fidelity and acceptance
pants with dementia select which of three faces (happy, We use semi-structured interviews to capture partici-
neutral, unhappy) best depict their mood (adapted from pants’ qualitative experiences with the study and inter-
Rosenberg and Mittelman & Epstein [42, 43]). vention. In addition, the app records the frequency,
Directly before and after IML, caregivers in the IG duration, pause or end of music listening as well as
group will use visual analogue scales ranging from 0 to whether songs are skipped. We will use this quantitative
100 [34] to assess the person with dementia’s emotional information to assess the quality of the playlists as well
well-being and arousal via the app. Directly after the lis- as intervention fidelity (i.e., the extent to which the inter-
tening session, caregivers will additionally use the app vention was implemented as intended). All caregivers will
to indicate whether the person with dementia displayed use the System Usability Scale to rate the user-friendli-
each of 19 behaviours (e.g., “singing”, “listening atten- ness of the app and tablet (10 items; 1 = “do not agree at
tively”; yes/no) during the listening session. In addition, all” to 5 = “fully agree”; [47]) during the third home visit.
caregivers can describe their observations of the person Caregivers in the IG will additionally complete a self-
with dementia during the listening session using an open developed paper-and-pencil questionnaire to assess their
answer format. overall experience with the app, tablet, and intervention
During the three home visits, a trained research assis- (14 items, e.g., “Would you want the person with demen-
tant will use a revised version of the DeCS [17] to assess tia to continue with the listening sessions?”, 1 = “definitely
the behaviour of the person with dementia during the lis- not” to 4 = “definitely yes”).
tening session.
Statistical analysis
Dyadic interaction quality We will use SPSS (IBM Corp., Armonk, NY) and R (R
Caregivers will assess the dyadic interaction quality daily Development Core Team, Vienna, Austria) to conduct
via the app and as part of the paper-and-pencil ques- all analyses. We will check whether there are mean-
tionnaire at T0, T1, T2, and T3. Caregivers will use a ingful differences between the baseline characteristics
self-constructed questionnaire (8 items, e.g., “We experi- of the IG and CG. In accordance with the CONSORT
ence moments of joy together”; 0 = “strongly disagree” to statement both “intention-to-treat” and “per-protocol”
4 = “strongly agree”). (i.e., using the sample of participants who adequately

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 8 of 10

adhered to the intervention protocol by completing Ethical approval

at least five out of the 21 sessions) analyses will be Ethical approval was obtained from the Ethics Commit-
conducted for comparison. We will also conduct sen- tee of the Faculty of Social and Behavioural Sciences of
sitivity analyses to investigate whether missing data, the Friedrich Schiller University Jena (committee’s ref-
baseline differences, or the total number of listening erence number: FSV 22/013). The IML intervention is a
sessions has any impact on the outcomes. non-invasive.
For analysing the effect of the intervention on the
primary outcome (i.e., individual goal attainment), car- Discussion
egivers’ GAS-ratings will be averaged for each partici- This RCT evaluates the effectiveness of an app-based
pant across all specified goals. Then, we will use t-tests IML intervention for the home care setting. Due to large
to compare the average goal attainment between mem- and growing population of people with dementia – most
bers of the IG and CG. In the case of baseline differ- of whom are living at home and cared for by family mem-
ences in the IG and CG, we will conduct regression bers – finding ways to improve the quality of life of peo-
analyses to assess the impact of the intervention on ple with dementia and their caregivers represents one
individual goal attainment while statistically control- of society’s most pressing public health challenges. IML
ling for the relevant variables. In addition, we will cal- has been shown to be a highly accepted, affordable and
culate and compare the proportion of participants who effective non-pharmacological intervention for people
completely or partially attained their goals, maintained with dementia in the institutionalized setting. Build-
the initial state, or reported mild/ severe deterioration ing on these positive findings, we examine whether the
of their goals in each group. current app-based IML intervention can be successfully
Secondary outcomes (including data from the daily implemented in the home care setting and improve the
assessments) will be analysed using multilevel models well-being and quality of life of people with dementia and
with two levels, with assessment points (level 1) nested their caregivers. The app is designed to provide an easy,
in participants (level 2). Average treatment effects affordable and effective way to construct personally-rel-
will be analysed by including group membership as a evant music playlists and implement IML interventions
level-2 predictor (0 = CG, 1 = IG). Person-level mod- at home. Integrated tutorials empower family caregivers
erator variables will be included only if necessary, in to successfully implement the intervention and manage
accordance with the results of the sensitivity analy- arising challenges.
ses. For outcomes that will be assessed for people with A major strength of the study is that we use a variety
dementia as well as for their caregivers (e.g., physi- of assessment methods and consider the perspectives of
ological stress), three-level multilevel models will be people with dementia, their caregivers, as well as exter-
used to account for within and between dyadic effects. nal observers and physiological measures of stress. We
Assessment points (level 1) will be nested in partici- employ traditional paper-and-pencil questionnaires, app-
pants (level 2), and participants will be nested within based questionnaire measures, in-person behavioural
dyads (level 3). Full maximum likelihood estimation observations, video analysis, semi-structured interviews
will be used to account for any missing data. and hair analysis. We consider how IML is related to daily
To analyse the data from the behavioural observa- fluctuations as well as longer-term changes. The daily
tions, we will compute frequency scores for time units assessments via app help us to avoid retrospective bias
1–5 (i.e., 20 min of behavioural observation bevor and increase the ecological validity of our study. Finally,
IML; pre-intervention period in the IG), 6–10 (i.e., we consider how IML affects not only scores on standard-
20 min of IML in the IG) and 11–15 (i.e., 20 min of ized measures but also individual goal attainment. Our
behavioural observation after IML; post-intervention measures are specifically designed for the target group
period in the IG). These frequency scores will then of people with dementia who have diverse abilities and
be compared within and between both groups (IG vs. symptoms, and who may have difficulty communicating.
CG). The behavioural observations and measures of acute and
Finally, to assess feasibility and acceptance, we will chronic stress allow us to assess people with dementia’s
use a qualitative content analysis to analyse the con- well-being without verbal or written communication, and
tent of the semi-structured interviews. Video record- the DeCS coding system [17] was adapted to our non-
ings are analysed qualitatively. We will also examine pharmacological intervention and the observed group
the descriptive statistics of the quantitative measures of of people with dementia. Further strengths of the study
playlist quality, intervention fidelity, user-friendliness include the sufficiently powered sample of dyads and
of the app and tablet, and overall experience with the the inclusion of people at all stages and with all types of
intervention. dementia. However, the study also has limitations: the

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Jakob et al. BMC Psychiatry (2024) 24:230 Page 9 of 10

design does not allow blinding, and the extent to which Availability of data and materials
The datasets used and/or analysed during the current study are available from
family caregivers implement the intervention as intended the corresponding author on reasonable request.
remains to be seen.
The relevance of feasible and effective interventions Declarations
that improve the quality of life of people with dementia
living at home and their caregivers is evident. Our study Ethics approval and consent to participate
Ethical approval was obtained from the Ethics Committee of the Faculty of
will demonstrate the extent to which an app-based IML Social and Behavioural Sciences of the Friedrich Schiller University Jena (com-
intervention for people with dementia living at home can mittee’s reference number: FSV 22/013). Informed consent will be obtained
be delivered by family caregivers and improve the well- from the dyads or their legal guardians.
being of people with dementia and caregivers, as well as Consent for publication
improve the caregiving experience. Insight regarding the Not applicable.
acceptance and usability of the app and the tablet will
Competing interests
inform further development of the app and other digital The authors declare no competing interests.
assistance technologies. A sustainability concept is being
developed for the continuation of IML in practice. Author details
1
Department of Counseling and Clinical Intervention, Institute of Psychology,
Abbreviations Friedrich Schiller University Jena, Humboldtstrasse 11, 07743 Jena, Germany.
BPSD Behavioural and psychological symptoms of dementia
CG Control group Received: 12 January 2024 Accepted: 18 March 2024
DeCS Dementia Coding System
EMA Ecological Momentary Assessment
GAS Goal attainment scaling
IG Intervention group
IML Individualized music listening
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