Condition category
Mental and Behavioural Disorders
Date applied
29/03/2008
Date assigned
29/05/2008
Last edited
29/05/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samia Toukhsati

ORCID ID

Contact details

School of Psychology
Psychiatry and Psychological Medicine
Building F
Caulfield Campus
Monash University
Melbourne
3145
Australia
+61 (0)3 9903 2367
Samia.Toukhsati@med.monash.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluating the effects of music and animal-assisted therapy on depression in aged care residents

Acronym

Study hypothesis

The primary aim of this randomised clinical study is to evaluate the efficacy of two alternative therapies, music therapy (MT) and animal-assisted therapy (AAT), to reduce depressive symptomatology in cognitively intact elderly individuals residing in aged care facilities. A secondary aim of this study is to explore neurophysiological mechanisms that may underpin any observed effects of the alternative therapy interventions. The following hypotheses have been formulated on the basis of the above aims:
1. MT and AAT will improve quality of life and reduce the physical, cognitive, affective and interpersonal deficits associated with depression in the elderly to a greater extent than the no intervention control group
2. MT and AAT will produce observable changes in electroencephalogram (EEG) indices of depression to a greater extent than the no intervention control condition
3. Changes observed in psychological indices of depression will correlate with changes observed on physiological measures of depression

Ethics approval

Ethics approval received from the Monash University Standing Ethics Committee on Research Involving Humans (SCERH) on the 20th February 2008

Study design

A multicentre, double-blind, nested, randomised controlled trial with three independent groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Experimental conditions:
Music therapy and animal-assisted therapy will each be presented by accredited therapists twice weekly to small groups (N = 5) for four weeks, yielding a total of eight therapeutic sessions. Therapy session will last approximately 45 minutes. Music therapy will comprise listening to preferred music, singing, and playing percussion instruments. Animal-assisted therapy will comprise activities with a temperament-tested dog, such as patting, grooming, playful interaction and watching the animal perform tricks. Participants assigned to either treatment will continue to receive diversional activities already in place at their respective facilities.

Control condition:
The non-intervention control group will continue to receive diversional activities already in place at the respective facilities, but will not receive an additional treatment.

Post-intervention measures will be taken the week after the interventions have been completed and post-testing will take one week to complete per facility.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Affective: symptoms of depression will be measured with the mood disorder module of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-IV-TR) and the GDS
2. Cognitive: general cognitive status will be assessed using the SMMSE. The more specific domain of executive functioning will be assessed using the Trail Making Test Part A and B, Digit-Symbol Coding and the Controlled Oral Word Association Test (COWA).
3. General health and well-being: assessed using the Australia Quality of Life (AQoL) Scale. Pain will be assessed the Present Pain Index (PPI) and the Modified Cumulative Illness Rating Scale (MCIRS).

All outcomes will be measured over the course of four days prior to the four week intervention period and in the week following treatment.

Secondary outcome measures

Neurophysiological measures:
Two EEG components will be explored. First, previous research has indicated that depression is associated with relative left frontal asymmetry and that pharmacological and psychological treatment for depression may normalise this brain activity pattern. Second, abnormal P300 responses (such as reduced amplitude and increased latency) have also been observed in individuals with depression. Given these findings, this study will explore the effect of alternative therapies on the topographic distribution of spectral power and the amplitude and latency of the P300 evoked potential.

All outcomes will be measured over the course of four days prior to the four week intervention period and in the week following treatment.

Overall trial start date

01/06/2008

Overall trial end date

30/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (65+ years), either sex
2. A score of at least 20 on the Standardised Mini Mental Status Examination (SMMSE)
3. A score of at least 5 on the Geriatric Depression Scale (GDS)
4. English fluency

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

150 in total

Participant exclusion criteria

1. Diagnosis of dementia or delirium
2. Significant hearing or vision impairments
3. Unable to provide informed consent (due to mental status)
4. Placed in the facility within the previous three weeks

Recruitment start date

01/06/2008

Recruitment end date

30/08/2009

Locations

Countries of recruitment

Australia

Trial participating centre

School of Psychology, Psychiatry and Psychological Medicine
Melbourne
3145
Australia

Sponsor information

Organisation

Monash University (Australia)

Sponsor details

School of Psychology
Psychiatry and Psychological Medicine
Building F
Caulfield Campus
Melbourne
3145
Australia
+61 (0)3 9903 2367
Samia.Toukhsati@med.monash.edu.au

Sponsor type

University/education

Website

http://www.monash.edu.au

Funders

Funder type

Charity

Funder name

J.O. & J.R. Wicking Trust (Australia and New Zealand [ANZ] Trustees) (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Monash University (Australia)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes