Research report
Non-Pharmacological interventions for the anxiety in patients with dementia. A cross-over randomised controlled trial

https://doi.org/10.1016/j.bbr.2020.112617Get rights and content

Highlights

  • Our results are in accordance with the current literature.

  • Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD.

  • Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD.

  • The type of music, the duration of the intervention and the long-term benefits still remain unclear.

  • There is a big need of further research with stronger possible evaluation methods.

Abstract

Background

Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to be a crucial and big problem in dementia. Anxiety several times remains under-diagnosed because it is often considered to be a psychological response to cognitive decline. As only the 10 % of patients were correctly treated, the pharmacological treatment should be well- considered. The aim of this study was to evaluate three non-pharmacological interventions for the treatment of anxiety in dementia.

Methods

A cross-over randomised controlled trial with 60 participants (different types and stages of dementia) conducted in Greece. The sample was randomly assigned to 6 different groups of 10 participants each. The non-pharmacological interventions that have been evaluated are: a) Music Therapy b) Exercise and c) Aromatherapy & Massage. The measurements that were used are: MMSE, ACE-R, GDS, FRSSD and NPI questionnaire. The interventions lasted 5 days and there was two days off as a wash-out period. There was no drop-out rate.

Results

The study showed that the most effective intervention is Music therapy. The second most effective intervention is Exercise and the third one is Aromatherapy and Massage. In the parenthesis p results indicate that Music Therapy's p is less than 0.05 in comparison with Exercise and Aromatherapy and Massage and therefore the sequence of the interventions does not interfere with the results. (p = <0.05, p = 0.55, accordingly). Caregivers' burden also reduced with MT. In the parenthesis p results indicate Music Therapy's p is less than 0.05 in comparison with the two other interventions and therefore the sequence of the interventions does not interfere with the results, as well (p = <0.05, p = 0.19).

Conclusions

Our results are in accordance with the current literature. Music Therapy is a promising alternative intervention for the treatment of anxiety in PwD. Music Therapy is an effective non-pharmacological treatment for the reduction of the caregivers' burden, because of the anxiety symptoms in PwD, such as lack of sleep, lack of personal time, unhealthy lifestyle, lack of solutions on what to do with their patients etc. The type of music, the duration of the intervention and the long-term benefits remain unclear. There is a big need of further research with stronger possible evaluation methods.

Introduction

Behavioural and Psychiatric Symptoms in dementia (BPSD) tend to appear from the early stage of Mild Cognitive Impairment (MCI) to the severe stages of dementia. The occurrence of BPSD has been recognized in most types of dementia; Alzheimer’s Disease (AD), Vascular dementia (VaD), Dementia with Lewy Bodies (LBD), Parkinson’s dementia (PDD) and Frontotemporal dementia (FTD) [1]. BPSD can be categorized in clusters; predominantly affective, psychotic, hyperactive, or apathic [2]. The presence of BPSD is related to rapid cognitive decline, institutionalization and higher risk of mortality [3]. Furthermore, the caregivers’ burden should be thoroughly- considered.

Anxiety is a common symptom in dementia and Mild Cognitive Impairment (MCI) and several times remains under-diagnosed because it is often viewed as a psychological response to cognitive decline. Anxiety is a heterogeneous disease with no clear biomarker [4]. Current pharmacological treatment includes anti-psychotic, benzodiazepines and anti-depressant drugs, although their efficacy remains questionable. Pharmacological treatment for the BPSD should be well-considered. According to a recent study only 10 % of patients were correctly treated with suitable drugs [5]. According to the latest studies there is some evidence that MT can be beneficial for the reduction of some BPSD, including anxiety. A recent pilot randomised controlled trial that conducted in Canada aimed to evaluate the efficacy of MT in patients with dementia (PwD) with anxiety symptoms [6]. Patients were randomised to either a group of MT intervention or to an Active Engagement Intervention (AEI) group using an online randomization programme. The MT intervention lasted up to eight hours of face-to-face MT, for over four weeks of bi-weekly, hour-long sessions. The therapist was an accredited music therapist, who encouraged the PwD to actively engage in the process. The music that had been selected was in accordance with the participant's preferences. All participants seemed to engage in a meaningful way to the intervention. The PwD in AEI group also received up to eight hours of intervention from a social worker. Their intervention included occupational activities. The analysis of a total number of 16 participants (10 received MT and 6 received AEI intervention) demonstrated that MT can be beneficial for the reduction of anxiety in dementia, but the results are not superior to AEI intervention. However, this pilot study claims that its results are in contradiction with the current bibliography. Another recent trial that aimed to evaluate if MT can reduce anxiety symptoms in PwD conducted in Italy [7]. The study included 120 participants. All groups received standard care and two groups received individualized MT or Listening to Music sessions (LtM), twice a week for ten weeks (the sessions lasted for 30 min). The study mentions that MT and LtM did not have significant results on reducing anxiety in PwD. There are no recent studies that had evaluated the efficacy of Exercise on the reduction of anxiety. No recent original articles that assess the efficacy of Aromatherapy and Massage for the reduction of anxiety found, as well.

In the current study we used MT therapy because of the few evidences that has promising results on the reduction of the anxiety symptoms in dementia. Moreover, we used Exercise intervention as an alternative solution, as it does not belong to cognitive nor sensory stimulated interventions. Finally, the reasons that cognitive non-pharmacological interventions have not been used in our study are; a) some trials have used psychological approaches and found promising results but this is different from cognitive approaches, b) some trials used cognitive non-pharmacological interventions that require time to educate the patients. This was impossible to happen in our study because the duration of our interventions were short and also we included patients in different stages of dementia and therefore it was impossible to educate them all in the same period of time and lastly c) some trials have not come to safe conclusions and require further research. Specific examples of the above-mentioned reasons are the trials below; one Cochrane review mentions that psychological interventions reduce clinician- rated anxiety but not self- rated anxiety [8]. Another related study shows the same results [9]. The trials that have been included in this review used cognitive behavioural therapy (CBT), counseling, and interpersonal psychodynamic therapy. However, psychological interventions differ from cognitive non-pharmacological approaches (such as Validation therapy, Reminiscence, Reality Orientation and Cognitive Stimulation Therapy). This combination of cognitive and psychological approaches has been excluded from our study based on the reason a, mentioned in the beginning of the paragraph. Other studies that have shown promising results have used cognitive non-pharmacological interventions but involved self- monitoring for anxiety, deep breathing and other optional skills (such as behavioural activation and sleep management) for 12 weekly home- sessions and found promising results on the reduction of anxiety [10,11]. This kind of trials have been excluded in our study based on the reason b, mentioned in the beginning of the paragraph. Other trials have not come to safe conclusions and claim that further research is required based on the reason c, mentioned in the beginning of the paragraph [[12], [13], [14]]. For all that reasons cognitive non-pharmacological interventions excluded from our current study. Therefore, we used a sensory intervention (aromatherapy and massage) as a third option.

The aim of this study was to evaluate three non-pharmacological interventions for the management of anxiety in dementia. These are: a) Music Therapy (MT) b) Exercise and c) Aromatherapy & Massage.

Section snippets

Subjects

Sixty (60) patients participated in the current study. All the patients had been diagnosed at the Neurology Department (Dementia Office) of the General Hospital of Thessaloniki “G. Papanikolaou” and Athens “G. Gennimatas”. The patients and caregivers have informed and their caregivers have given consent. There was no dropout rate. The sample was randomly assigned into six different sequences of ten participants each. Baseline characteristics of the sample are shown on Table 1. Furthermore, we

Results

There were no differences between males and females between the six categories defined by the sequence schemes (p = 0.753). Furthermore, among categories no differences were found on age (p = 0.235), years of education (p = 0.709), MMSE (p = 0.988), ACE-R (p = 0.849), GDS (p = 0.484), FRSSD (p = 0.996), NPI Result (p = 0.588) and NPI Distress (p = 0.756). There was no relationship between the categories and the type of dementia (p = 0.554). Twenty-five patients were males (41.7 %). The

Discussion

This study shows that MT is the most effective non-pharmacological intervention for the reduction of the anxiety symptoms in PwD compared to Exercise and Aromatherapy. It is also the most effective intervention for the reduction of the caregivers’ burden, as well. Although the scores of NPI and NPI Distress were also reduced after the interventions of Exercise and Aromatherapy and Massage, these scores were significantly lower in MT compared to the others.

Our results seem to be in accordance

Author statement

Authors have made the changes that the reviewers suggested. We thank the reviewers for their comments. The changes are highlighted in the manuscript.

Declaration of Competing Interest

None.

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