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

ISRCTN ISRCTN75503960
DOI https://doi.org/10.1186/ISRCTN75503960
Secondary identifying numbers N/A
Submission date
29/10/2015
Registration date
08/01/2016
Last edited
14/01/2020
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

Plain English summary of protocol

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 May 2019

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

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

Contact information

Dr Vasiliki Orgeta
Public

University College London
Division of Psychiatry (formerly Mental Health Sciences Unit)
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

ORCiD logoORCID ID 0000-0001-8643-5061
Phone 02076799294
Email v.orgeta@ucl.ac.uk

Study information

Study designFeasibility study. Randomised controlled intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleIDEA: Intervention to prevent Depressive symptoms and promote well-being in EArly stage dementia: development and feasibility
Study acronymIDEA
Study objectivesThe 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(s)Camberwell St Giles Research Ethics Committee, 01/06/2016, ref: 16/LO/0540
Health condition(s) or problem(s) studiedEarly-stage dementia
InterventionParticipants 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 typeBehavioural
Primary outcome measure1. 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 measuresPeople 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 study start date31/10/2015
Completion date31/01/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment63
Key inclusion criteria1. 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)
Key exclusion criteriaPeople at risk of suicide (clinicians’ judgement)
Date of first enrolment03/10/2016
Date of final enrolment28/09/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study 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

Sponsor information

University College London
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Phone 0207679 2000
Email v.orgeta@ucl.ac.uk
Website N/A
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Alzheimer's Society
Private sector organisation / Associations and societies (private and public)
Alternative name(s)
alzheimerssoc
Location
United Kingdom

Results and Publications

Intention to publish date31/01/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planWe 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.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 08/02/2018 Yes No
Results article results 01/02/2019 14/01/2020 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

14/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/10/2018: The overall trial end date was updated from 31/05/2019 to 31/01/2019.
28/08/2018: Publication reference added.
26/03/2018: Recruitment end date was changed from 28/02/2018 to 28/09/2018 and overall end date was changed from 31/01/2019 to 31/05/2019.
08/09/2017: Internal review
01/09/2017: Ethics approval information added. Individual patient level data has been added.