Condition category
Mental and Behavioural Disorders
Date applied
17/07/2014
Date assigned
31/07/2014
Last edited
04/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Reminiscence and life review therapy is a way of remembering, talking about and sharing the important events and memories of one's life. The treatment is thought to help provide comfort and meaning to a person's experiences. Music, photographs, videos, and items that have special meanings can all be used to trigger memories and the sharing of stories. The therapy is often used with people with dementia. However, it is not really known what it is about remembering the past that is of benefit. It's possible that it is a particular type of memory that is helpful. In this study, we will be looking at whether remembering different types of memories (nostalgic versus non-nostalgic memories) generate different psychological feelings. Research with people who don't have dementia has shown that different types of memory can produce different psychological effects. So, in this research, we will be looking to see whether the same effects hold true for people who have recently been diagnosed with dementia.

Who can participate?
People who have been diagnosed with dementia (Alzheimer's disease, Vascular Dementia, Dementia with Lewy bodies or Mixed Dementia) and have mild to moderate memory problems.

What does the study involve?
This study involves two separate experimental studies. In Study 1, each person who takes part is randomly allocated into one of two groups (nostalgia or control). Each participant from the nostalgia group is asked to remember a nostalgic event from their past. They are then asked to describe how they feel at that moment. Afterwards, they complete a series of questionnaires on how they feel at that moment. Participants in the control group are also asked to remember an ordinary event from their past. Like the nostalgia group, they are then asked to describe how they feel at that moment and complete the same series of questionnaires. In Study 2, each participant who takes part is randomly allocated into one of two groups (nostalgia or control). Each participant in the nostalgia group is asked to listen to a song which they have previously identified to hold a special meaning for them. They are then asked to describe how they feel at that moment and complete the same series of questionnaires as in Study 1. In the control group, each participant listens to a song which they have not identified as having special meaning to them. They are then asked to describe how they feel and complete the series of questionnaires. Before the participants begin each experimental study, we go through a brief questionnaire with them so that we have a better idea of how well their memory is working. At the end of each the study, we ask them about their experiences of taking part in the study. At that point we are also be able to give them more detailed information about the project and their role in the study. Each study will last about 20 minutes.

What are the possible benefits and risks of participating?
We do not believe that there has been any research with people with dementia which involves asking participants to recall memories in this way. However, there has been a great deal of research into reminiscence and life story work, which are both often used as therapy in dementia care. Although there are reports of adverse reactions, such as people being distressed during the therapy, these are rare. In general, both reminiscence and life review are reported to have either beneficial or neutral effects.

Where is the study run from?
The University of the West of England, Bristol (UK)

When is the study starting and how long is it expected to run for?
From October 2014 to April 2016.

Who is funding the study?
The University of the West of England, Bristol (UK)

Who is the main contact?
Mr Sanda Ismail
sanda.ismail@uwe.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sanda Ismail

ORCID ID

Contact details

University of the West of England
Glenside Campus
Bristol
BS16 1DD
United Kingdom
+44 (0)1173288907
sanda.ismail@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The psychological impacts of nostalgia for people with dementia: a parallel randomised controlled experimental study

Acronym

PsychNosDem

Study hypothesis

Aim of research: To explore the psychological impact of nostalgic memories compared to non-nostalgic memories on people affected by dementia.

On 29/01/2015 the following changes were made to the trial record:
1. The scientific title was changed from 'The psychological impacts of nostalgia for people with dementia: a randomised double-blind controlled experimental study' to 'The psychological impacts of nostalgia for people with dementia: a parallel randomised controlled experimental study'.
2. The study design was changed from 'Randomised double-blind controlled multi-centre experimental study' to 'Parallel randomised controlled multi-centre experimental study'.
3. The target number of participants was changed from 86 to 84.

Ethics approval

NRES Committee East of England – Norfolk, 27/01/2015, REC ref: 14/EE/1237, IRAS Project ID: 161394

Study design

Parallel randomised controlled multi-centre experimental study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

NA

Condition

Dementia

Intervention

Current interventions as of 29/01/2015:
Nostalgia groups:
1. Narrative nostalgia - Participants will be instructed to bring to mind a nostalgic memory. Specifically, they will be instructed to do the following: “According to the New Oxford Dictionary, ‘nostalgia’ is defined as a ‘sentimental longing for the past.’ Please think of a nostalgic event in your life. Specifically, try to think of a past event that makes you feel most nostalgic. Bring this nostalgic experience to mind. Immerse yourself in the nostalgic experience. How does it make you feel? Please spend a couple of minutes thinking about how it makes you feel. Please describe this nostalgic event (i.e., describe the experience).”
2. Music-evoked nostalgia - Participants in the music-evoked nostalgia group will listen to one of the three nostalgic songs that they had previously identified. They will be asked to spend a couple of minutes immersing themselves in the nostalgic experience. They will then be asked to describe how they feel and their experience after listening to the song.

Control groups:
1. Narrative control - In the narrative control group, they will be instructed to bring to mind an ordinary event in the past: “Please bring to mind an ordinary event in your life. Specifically, try to think of a past event that is ordinary. Bring this ordinary experience to mind. Immerse yourself in the ordinary experience. How does it make you feel? Please spend a couple of minutes thinking about how it makes you feel. Please describe this ordinary event (i.e., describe the experience)”.
2. Music control - In the music-control group, participants will receive the song of a yoked partner in the music-evoked nostalgia condition. They will be asked to spend a couple of minutes immersing themselves in the nostalgic experience. They will then be asked to describe how they feel and their experience after listening to the song.

Previous interventions:
Intervention groups:
1. Narrative nostalgia - Participants will be provided with a definition of nostalgia and instructed to bring to mind an event that makes them feel nostalgic. Specifically, "According to the Oxford Dictionary, nostalgia is defined as a 'sentimental longing for the past.' Please think of a nostalgic event in your life. Specifically, try to think of a past event that makes you feel most nostalgic. Bring this nostalgic experience to mind. Immerse yourself in the nostalgic experience. How does it make you feel? Please spend a couple of minutes thinking about how it makes you feel. Please write down four keywords relevant to this nostalgic event (i.e., words that describe the experience)".
2. Music-evoked nostalgia - Participants will listen to one of three nostalgic songs that they have previously identified. They will be asked to immerse themselves in the nostalgic experience. They will then be asked to write down four keywords relevant to this nostalgic event (i.e., words that describe the experience).
Control groups:
1. Narrative control - Participants will be instructed as follows: "Please bring to mind an ordinary event in your life. Specifically, try to think of a past event that is ordinary. Bring this ordinary experience to mind. Immerse yourself in the ordinary experience. How does it make you feel? Please spend a couple of minutes thinking about how it makes you feel. Please write down four keywords relevant to this ordinary event (i.e., words that describe the experience)".
2. Music control - Participants in this group will be given the favourite nostalgic song of a yoked partner in the music-evoked nostalgia group to listen to via an audio device. They will then be asked to write down four keywords relevant to this event (i.e., words that describe the experience).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self-esteem - Self-esteem will be measured with the State Functions of Nostalgia Scale and The Rosenberg Self-Esteem Scale. The State Functions of Nostalgia Scale is a 12-item scale with 4 sub-items measuring state self-esteem (1 = Strongly disagree; 6 = Strongly agree). The Rosenberg self-esteem scale is a 10-item scale that measures global self-esteem and rated from strongly agree to strongly disagree. For items 1, 2, 4, 6, and 7: Strongly agree = 3; Agree = 2; Disagree = 1; Strongly disagree = 0 . For items 3, 5, 8, 9, and 10 (which are reversed in valence): Strongly agree = 0; Agree = 1; Disagree = 2; Strongly disagree = 3.
2. Social connectedness - Social connectedness will be measured with the State Functions of Nostalgia Scale The State Functions of Nostalgia Scale is a 12-item scale with 4-sub-items measuring social connectedness (1 = Strongly disagree; 6 = Strongly agree).
3. Meaning/Purpose in life - Meaning/ Purpose in life will be measured with the State Functions of Nostalgia Scale and The Perceived Purpose scale . The State Functions of Nostalgia Scale is a 12 item scale with 4-sub-items measuring meaning in life (1 = Strongly disagree; 6 = Strongly agree). The Perceived Purpose scale is a self-report measure of purpose in life. It comprises of 8 items rated on 6 –point Likert scale with scores ranging from 8 to 48.

The outcomes will be measured immediately following the manipulation of nostalgia.

Secondary outcome measures

NA

Overall trial start date

01/10/2014

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis made by a consultant psychiatrist of either probable Alzheimer's disease according to the NINCDS-ADRDA criteria (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association) or probable Vascular Dementia according to the NINDS-AIREN criteria (National Institute of Neurological Disorders and Stroke- Association Internationale pour la Recherche et l'Enseignement en Neurosciences) or dementia with Lewy bodies or mixed dementia
2. Participants must have a mild to moderate level of cognitive impairment before they commence the research e.g. an MMSE score of at least 18
3. All participants will have been told of their diagnosis as evidenced in their medical notes by a practitioner/ nurse/ doctor
4. Participants should be identified as having capacity to give consent by a clinician with access to the patient's recent cognitive assessment in the memory clinic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

84

Participant exclusion criteria

Current exclusion criteria as of 29/01/2015:
1. Participants diagnosed with Fronto-Temporal Dementia
2. People who initially have capacity at the time of assessment but who have lost capacity to consent before the study session
3. People who have current health problems such as high levels of distress or other factors (e.g., a recent bereavement) that preclude involvement in the study
4. People with a known history of traumatic abuse or other incidence which can cause them pain while remembering such events

Previous exclusion criteria:
1. Participants diagnosed with Fronto-Temporal Dementia
2. Participants who have lost capacity to consent before the research session
3. Participants with significant pre-morbid mental health problems e.g. major psychotic breakdown or depression

Recruitment start date

01/03/2015

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Avon and Wiltshire Mental Health Partnership NHS Trust
SN15 1GG
United Kingdom

Trial participating centre

Research Institute for the Care of the Elderly
BA1 3NG
United Kingdom

Sponsor information

Organisation

University of the West of England (UK)

Sponsor details

Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
+44 (0)117 965 6261
info@uwe.ac.uk

Sponsor type

University/education

Website

http://www1.uwe.ac.uk/aboutus

Funders

Funder type

University/education

Funder name

University of the West of England

Alternative name(s)

UWE

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Peer-reviewed journals, academic conferences and PhD thesis report

Intention to publish date

01/11/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

NA

Publication citations

Additional files

Editorial Notes