Condition category
Mental and Behavioural Disorders
Date applied
02/11/2016
Date assigned
16/11/2016
Last edited
17/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dementia is a common condition in the aging population. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worse over time. Alzheimer’s disease (AD) is the most common cause of dementia. It is a growing problem worldwide, affecting millions of people over the age of 60. In some previous research it was found that the way in which information is given about a diagnosis of dementia affects how well this information is remembered. Another study showed that recalling past memories can improve how people feel about themselves, for example by increasing self-esteem. The aim of this study is to combine these two projects to see whether recalling a past memory beforehand leads to better recall of information about an illness.

Who can participate?
Patients who have recently been diagnosed with dementia.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to remember a nostalgic memory and those in the second group are asked to remember an ordinary event in the past. All participants complete questionnaires asking them about how they feel before taking part in a memory test. This involves a researcher reading out 24 illness-related statements in four blocks of six and participants are asked to remember as many as possible after each block.

What are the possible benefits and risks of participating?
There are no direct benefits for participants taking part. There are no major risks in taking part in this study. Some of the statements to remember might be upsetting to some people but the researcher will support the participant if this happens. The participant will be fully debriefed after the study and the researcher will ensure the participant is feeling ok before finishing the appointment.

Where is the study run from?
The RICE Centre (UK)

When is the study starting and how long is it expected to run for?
April 2016 to May 2017

Who is funding the study?
Alzheimer’s Research UK (UK)

Who is the main contact?
Professor Richard Cheston
richard.cheston@uwe.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Cheston

ORCID ID

http://orcid.org/0000-0002-7466-3777

Contact details

University of the West of England
Dept of Health and Social Sciences
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
+44 117 3288927
richard.cheston@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32203

Study information

Scientific title

A feasibility study to test whether using past memories to increase psychological resources leads to better recall of information about dementia

Acronym

Study hypothesis

Hypotheses:
1. Participants in the nostalgia (vs. control) condition will recall a higher proportion of high threatening dementia related statements compared to less threatening statements
2. Participants in the nostalgia (vs. control) condition will have higher self-esteem, social connectedness, and meaning in life
3. Recall of highly threatening statements in the nostalgia condition (vs control) will not be associated with increased levels of anxiety
4. There will be no differences in recognition between participants in the nostalgia and control arms
5. Participants in the nostalgia (vs control) condition will make fewer protective compared to threatening intrusion errors

Ethics approval

East of Scotland Research Ethics Service REC 2, 30/08/2016, ref: 16/ES/0097

Study design

Randomised; Interventional; Design type: Process of Care, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system

Intervention

Participants will be randomly allocated to either the intervention condition (n=15) or the control condition (n=15).

Intervention condition: Participants will be instructed to bring to mind a nostalgic memory

Control condition: Participants will be instructed to bring to mind an ordinary event in the past

Participants in both groups will complete questionnaires to measure psychological resources and complete a nostalgia manipulation check. Next participants will take part in the memory test; the recall of 24 statements related to dementia. From previous research half have been rated as high threat to identity and half rated as low threat to identity. These will be read out in four groups of six statements. Recall will be assessed immediately after each of the four groups and after a two-minute distracter task. Finally a recognition test will follow in which participants are provided with 48 statements and asked to identify the 24 they have previously heard. This research takes place within one session and lasts for approximately 45 minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Number of highly threatening and low threatening related statements recalled is measured by counting the correct number of statements recalled the single study appointment.

Secondary outcome measures

All outcomes are measured at the single study appointment.
1. Psychological resources are measured using State Functions of Nostalgia Scale
2. Recognition is measured by counting the number of correct statements participants recognise from a list of statements they have and haven’t heard previously
3. Intrusion errors (protective of self/threatening to self) are measured by counting the number of errors participants make in recall (protective error = valence reversal of high threat statements, repetition of low threat statements; threatening error = valence reversal of low threat statements, repetition of high threat statements)

Overall trial start date

20/04/2016

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis made within the previous 18 months of either probable Alzheimer’s disease or probable Vascular Dementia or a mixed form of these
3. Mild levels of cognitive impairment (e.g. MOCA score over 12 or equivalent score on an alternative assessment tool)
3. The capacity to consent to be part of the research
4. Sufficient communication skills to be able to take part in the research
5. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. A significant history of premorbid psychiatric problems
2. A diagnosis of dementia with Lewy Bodies (McKeith, 2002) or Frontaltemporal dementia (Snowden, Neary and Mann (2002))
3. If deficits in short term memory are not a primary cause of disability

Recruitment start date

01/10/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The RICE Centre
Building 8 Royal United Hospital Combe Park
Bath
BA1 3NG
United Kingdom

Sponsor information

Organisation

University of the West of England

Sponsor details

Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
+44 117 965 6261
Leigh.taylor@uwe.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Alzheimer’s Research UK

Alternative name(s)

ARUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Participants will be offered the option of being sent a summary of the results at the end of the study. Where funds allow, the protocol will be published and the findings from this study will be published in high quality open access journals with good impact factor. Findings will be presented at conferences. The trial management team will liaise with the university’s press team to establish an appropriate mechanism to disseminate to the wider public.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes