The use of alternative therapies to treat geriatric depression

ISRCTN	ISRCTN93225273
DOI	https://doi.org/10.1186/ISRCTN93225273
Protocol serial number	N/A
Sponsor	Monash University (Australia)
Funders	J.O. & J.R. Wicking Trust (Australia and New Zealand [ANZ] Trustees) (Australia), Monash University (Australia)

Submission date: 29/03/2008
Registration date: 29/05/2008
Last edited: 29/05/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Samia Toukhsati
Scientific

School of Psychology, Psychiatry and Psychological Medicine
Building F
Caulfield Campus
Monash University
Melbourne
3145
Australia

Phone	+61 (0)3 9903 2367
Email	Samia.Toukhsati@med.monash.edu.au

Study information

Primary study design	Interventional
Study design	A multicentre, double-blind, nested, randomised controlled trial with three independent groups
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluating the effects of music and animal-assisted therapy on depression in aged care residents
Study objectives	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(s)	Ethics approval received from the Monash University Standing Ethics Committee on Research Involving Humans (SCERH) on the 20th February 2008
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/08/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/06/2008
Date of final enrolment	30/08/2009

Locations

Countries of recruitment

Australia

Study participating centre

School of Psychology, Psychiatry and Psychological Medicine

Melbourne
3145
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes