Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sarah Baillon

ORCID ID

Contact details

University of Leicester
Psychiatry for the Elderly
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4597
sfb5@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0081129523

Study information

Scientific title

Acronym

Study hypothesis

This is a pilot study. The main aim of which is to assess the appropriateness of the recruitment criteria, feasibility of the schedule of measures and the acceptability of the measures to the subjects.
A secondary aim is to identify whether there are any large effects of the interventions which may be useful in refining the methodology of the definitive study.

Multi-Sensory Environments (MSE) are widely used in paediatrics, pain clinics, maternity facilities and in the care of the elderly with dementia. Studies have shown improvements in mood, enjoyment and levels of boredom, with increased relaxation and reduced agitation. Anecdotal evidence on the benefits of MSE in depression in the elderly points to a potential benefit which should be explored.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Depression

Intervention

1. Intervention Group (two one-to-one sessions in the MSE over one week)
2. Control Group (two one-to-one relaxation sessions over one week)

Added 21 August 2008: This trial was stopped because the facilities required to carry out the research (i.e. the multi-sensory environment) were closed and no other alternatives were available locally.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Hospital Anxiety and Depression Scale (HADS)
2. Beck Depression Inventory (BDI)
3. Visual Analogue Scales of Mood
4. Heart Rate Monitoring

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/05/2005

Reason abandoned

Lack of facilities

Eligibility

Participant inclusion criteria

12 subjects aged 65+ randomised to intervention or control, with a clinical diagnosis of depressive illness and capacity to give consent.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

12

Participant exclusion criteria

1. Organic brain syndrome
2. Significant hearing impairment
3. Significant sight impairment
4. Suicidal ideation
5. Electroconvulsive therapy (ECT) during course of trial
6. Evidence of delirium or change in psychotropis medication will trigger withdrawal

Recruitment start date

01/09/2003

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leicestershire Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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