IDEA: Intervention to prevent depressive symptoms and promote well-being in early stage dementia

Plain English Summary

Background and study aims
People with dementia are at risk of feeling depressed, sad and losing their enjoyment of life. This hinders their ability to perform everyday activities even more, poses them at risk of going to a care home earlier than they otherwise would have, and affects their quality of life. There are currently no known effective treatments as medications such as anti-depressants don’t work and have significant side effects. This study aims to develop a non-drug intervention (treatment) to prevent depression in people with early-stage dementia and test its feasibility (how easy it will be to use and how possible it is to use as a treatment). The intervention will be developed by combining evidence from studies using similar interventions for depression in older people, and by consulting people with dementia, their carers and professionals who support them. We will then find out whether this intervention is feasible and acceptable by conducting a pilot study, in order to establish the feasibility of running a bigger study at a later date.

Who can participate?
People with early-stage dementia who have received a diagnosis in the last 6 months. Carers of people with dementia also take part.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive their usual treatment and the Behavioral Activation intervention. Those in group 2 receive only their usual treatment. For those participants in group 1 (and their carers) the intervention is delivered by a
graduate psychologist. It involves identifying pleasant activities for the person with dementia and supporting them in engaging in these in every-day life. They are also taught simple skills of coping with stress (i.e. relaxation techniques), and make a plan of employing pleasant activities in the future with the support of the psychologist and the family carer. This study allows researchers to to find out how feasible it is to recruit people with dementia and their families to take part, and how many sessions participants are able to complete. This information may be used develop a bigger study at a later date.

What are the possible benefits and risks of participating?
There is no guarantee that the study will help people with dementia and their families, but the information provided in this study will help improve services for promoting well-being in people with early-stage dementia. There are no specific risks from taking part. If participants’ mood worsens considerably during the study, they will be referred to services that can help. Participants will receive all interventions that they would otherwise have received had they not taken part in this study.

Where is the study run from?
PRIMENT Clinical Trials Unit, University College London Medical School (UK)

When is the study starting and how long is it expected to run for?
October 2015 to January 2019

Who is funding the study?
Alzheimer's Society (UK)

Who is the main contact?
Dr Vasiliki Orgeta
v.orgeta@ucl.ac.uk

Trial website

Type

Public

Primary contact

Dr Vasiliki Orgeta

ORCID ID

http://orcid.org/0000-0001-8643-5061

Contact details

University College London
Division of Psychiatry (formerly Mental Health Sciences Unit)
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
02076799294
v.orgeta@ucl.ac.uk

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Scientific title

IDEA: Intervention to prevent Depressive symptoms and promote well-being in EArly stage dementia: development and feasibility

Acronym

IDEA

Study hypothesis

The IDEA study will assess the feasibility and acceptability of behavioral activation for preventing depressive symptoms in people with early-stage dementia, such as number of people consenting to the trial, and number completing the intervention. Secondary research questions include barriers to recruitment and intervention.

Ethics approval

Not provided at time of registration

Study design

Feasibility study. Randomised controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Early-stage dementia

Intervention

Participants will be randomly allocated to two treatment arms - treatment as usual or treatment as usual plus the Behavioral Activation intervention.

The intervention is an 8-session coping-based psychological intervention of behavioral activation delivered by a psychology graduate at the person’s home.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Number of eligible participants that consent to the study, and number of those finding
the intervention acceptable using 95 Confidence Intervals %
2. Number of dyads recruited per month and any barriers or facilitators to recruitment
3. Follow-up rates and number completing each outcome measure proposed for the main trial
4. Number of sessions attended
5. Standard deviations and correlations between repeated-measurements

Outcomes will be measured at 4 and 8 months.

Secondary outcome measures

People with dementia:
1. Depressive symptoms - Cornell Scale for Depression in Dementia (CSDD)
2. Self-rated and carer-rated dementia-specific quality of life for the person with dementia – DEMQOL
3. Neuropsychiatric symptoms - Neuropsychiatric Inventory (NPI)
4. Health services utilisation - Client Service Receipt Inventory (CSRI)

Carers:
1. Carers’ mental health - Hospital and Anxiety Depression Scale (HADS)
2. Carers' quality of life - EuroQoL EQ-5D (EQ-5D) and the Short Form-12 Health Survey (SF-12)

Outcomes will be measured at 4 and 8 months.

Overall trial start date

31/10/2015

Overall trial end date

31/01/2019

Reason abandoned

Participant inclusion criteria

1. People with mild dementia (MMSE ≤ 20)
2. People with dementia who have received a diagnosis in the last 6 months
3. Living in the community
4. Available family carer who can assist the person with dementia in the intervention and can act as an informant (weekly contact)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

People at risk of suicide (clinicians’ judgement)

Recruitment start date

03/10/2016

Recruitment end date

28/02/2018

Countries of recruitment

United Kingdom

Trial participating centre

PRIMENT Clinical Trials Unit
UCL Medical School Upper 3rd Floor Royal Free Campus Rowland Hill Street London NW3 2PF
London
NW3 2PF
United Kingdom

Organisation

Univeristy College London

Sponsor details

Gower Street
London
London
WC1E 6BT
United Kingdom
0207679 2000
v.orgeta@ucl.ac.uk

Sponsor type

University/education

Website

N/A

Funder type

Charity

Funder name

Alzheimer's Society

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Publication and dissemination plan

We will consult our PPI representatives in relation to audience for dissemination, and the communication channels that will be used. We will develop and disseminate regular newsletters informing clinicians and mental health professionals in the relevant Trusts of the progress of the study. We will disseminate the study findings in peer-reviewed publication journals. Study findings will also be presented at research conferences, and local symposiums. We will also inform GPs and other key dementia care professional groups.

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations