The use of alternative therapies to treat geriatric depression
| ISRCTN | ISRCTN93225273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93225273 |
| Secondary identifying numbers | N/A |
- 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
Scientific
School of Psychology, Psychiatry and Psychological Medicine
Building F
Caulfield Campus
Monash University
Melbourne
3145
Australia
| Phone | +61 (0)3 9903 2367 |
|---|---|
| Samia.Toukhsati@med.monash.edu.au |
Study information
| Study design | A multicentre, double-blind, nested, randomised controlled trial with three independent groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/06/2008 |
| Completion date | 30/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 150 in total |
| 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
3145
Australia
Sponsor information
Monash University (Australia)
University/education
University/education
School of Psychology, Psychiatry and Psychological Medicine
Building F
Caulfield Campus
Melbourne
3145
Australia
| Phone | +61 (0)3 9903 2367 |
|---|---|
| Samia.Toukhsati@med.monash.edu.au | |
| Website | http://www.monash.edu.au |
"ROR" |
https://ror.org/02bfwt286 |
Funders
Funder type
Charity
J.O. & J.R. Wicking Trust (Australia and New Zealand [ANZ] Trustees) (Australia)
No information available
Monash University (Australia)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Monash Uni | Melbourne, Monash Uni, University of Monash, Universitas Monash, MU
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
