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Contact Information:

Miss Melissa Melville
+44 300 300 1748
Melissa.melville@nelft.nhs.uk


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Be Part of Research - Trial Details - Compassion focused therapy - for mood in dementia
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Compassion focused therapy - for mood in dementia

Recruiting

Open to: All Genders

Age: Adult

Oxford London Chester Lincoln Rainham Norwich Dudley

Medical Conditions

Dementia

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Of the 850,000 people with dementia in the UK, many experience depression, anxiety or both. This can worsen cognition (e.g. memory and language) and behavioural problems, lead to relationship difficulties, and increase care home admissions. With medications for mood in dementia often ineffective, recent trends have moved towards nondrug interventions. However, the lack of interventions available with proven effects results in significant unmet needs. Compassion Focused Therapy (CFT) is a talking therapy, which addresses feelings of shame and stigma. Our team tested CFT with seven people with dementia, finding small improvements in depression, anxiety and self-criticism. One person said: “I have accepted the fact that I have a ‘memory problem’ and am happy being me. I do not blame myself anymore for something that’s not my fault.”

This project will assess CFT in the form of a ‘feasibility randomised controlled trial’ in 50 people with dementia and depression and/or anxiety. We will allocate them to either the intervention (twelve sessions of group CFT) or control (‘treatment as usual’). If put in the intervention group, people will be asked whether they prefer online or face-to-face groups and allocated accordingly. The outcome measures will be depression, anxiety, quality of life, cognition, self-compassion, relationship between caregiver and caregiver burden (where relevant) and costs, measured before and after the intervention period. We will interview participants, caregivers and clinical professionals delivering the therapy about their experiences. We aim to understand whether CFT is acceptable as an intervention for people with dementia and depression/ anxiety and whether conducting a future full-scale trial is likely to be possible. We will establish whether we can recruit enough participants, whether CFT is accessible online, whether people remain in the trial and if we can collect data on outcomes.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

08 Nov 2023 01 Feb 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39627126/ (added 04/12/2024)

If a participant chooses to take part, they will be randomly assigned to either the Compassion Focused Therapy group or a ‘control’ group. There is an equal, 50/50 chance of them being in either group. If they are in the control group, they will not receive any additional treatment.

The participants preference towards virtual or face-to-face meetings will be recorded and we will aim to allocate delivery of these CFT sessions accordingly. If the participant is randomly allocated to the intervention group, they will be invited to attend twelve, 60-minute online or face-to-face small group Compassion Focused Therapy sessions. These will occur once a week for twelve weeks. The sessions will involve meeting with a clinical professional and other people with dementia to discuss topics such as low mood, memory problems, and coping mechanisms. During the sessions the participant will also do activities such as gentle breathing and self-compassion exercises. There will be time to reflect as a group on the emotional experience of living with dementia. Sessions will end with suggesting home practices, with participants given session summaries. There will be time for social interaction before and after the session, either over a video conference platform or face-to-face.

If the participant is randomised to the Compassion Focused Therapy group, we will run a brief workshop for carers/supporters (if applicable) around the beginning of the Compassion Focused Therapy program. This will provide information on the principles of Compassion Focused Therapy, an outline of what we intend to do in sessions and tips on what can be done at home to support the therapy.

Regardless of which group the participant is allocated to (Compassion Focused Therapy or control), they will continue to have access to their usual care, including input from health and social care professionals, dementia medication their usual day activities.

Following discussion of any questions they may have with a researcher, and signing the consent form, all participants will be asked to:
-Meet with a researcher for approximately 1.5 hours to answer questions about their mood, anxiety, quality of life, and thinking. If applicable, we will also invite carers/supporters to attend this meeting.
-Meet with a researcher again after the 12 CFT sessions to answer the same questions as before, and again 6 months after the initial assessment. Each follow-up will take approximately 1.5 hours.

The participant may be randomly selected to attend an interview to discuss their experience of taking part in the study. Their carer/supporter (if applicable) may be asked to attend an interview separately to discuss their experience of supporting the person with dementia.


A person can put themselves forward to the research team if they:
1. Have been diagnosed with mild to moderate dementia;
2. Experience symptoms of anxiety or depression;
3. Have capacity to consent to take part in research;
4. Can communicate in English;
5. Have access to WiFi, enabling them to partake in online CFT groups, OR the ability to attend a face-to-face group;
6. Are not participating in another interventional research programme concurrently;
7. Aged 18 years and over;
8. People can be included whether or not they have a caregiver.

You can take part if:



You may not be able to take part if:


1. Communication is significantly impaired by cognitive decline2. Unable to speak English3. The participant is currently participating in another interventional research programme. 4. The participant has severe cognitive impairment as measured by the Clinical Dementia Rating scale.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Oxford Health NHS Foundation Trust
    Warneford Hospital Warneford Lane Headington
    Oxford
    OX3 7JX
  • Central and North West London NHS Foundation Trust
    Trust Headquarters 350 Euston Road Regents PLACE
    London
    NW1 3AX
  • Cheshire and Wirral Partnership NHS Foundation Trust
    Trust Headquarters Redesmere The Countess of Chester Health Park Liverpool Road
    Chester
    CH2 1BQ
  • Lincolnshire Partnership NHS Foundation Trust
    St George's Long Leys Road
    Lincoln
    LN1 1FS
  • North East London NHS Foundation Trust
    West Wing C E M E Centre Marsh Way
    Rainham
    RM13 8GQ
  • Norfolk and Suffolk NHS Foundation Trust
    Drayton High Rd
    Norwich
    NR6 5BE
  • Black Country Healthcare NHS Foundation Trust
    2nd Floor, Trafalgar House, 47-49 King St
    Dudley
    DY2 8PS

We appreciate that when an individual experiences memory problems, it may be hard to talk about things like mood and quality of life. The researchers carrying out the assessment, intervention, and interview have clinical experience and are working under supervision.
The participant will be encouraged but never forced to take part in a particular activity during the sessions.
Overall, the risks of taking part in this study are minimal. However, some people find that certain types of therapy do not help them or make them feel worse. If a participant finds any part of the study distressing, let us know and we can try to resolve the difficulty together or discuss other options of support. The participant is always free to withdraw from the study at any point.
If the participant loses capacity to consent, they will be withdrawn from the study and no further data will be collected, however data collected up until that point will be retained for use in the study. Withdrawing from the study will not affect the standard of care the participant receives.
If a participant takes part in the study and is allocated to the intervention group, we hope that their attendance at the sessions is a helpful experience. Previous research into compassion suggests that people can experience greater awareness, acceptance, control, improved coping and wellbeing. Regardless of whether the participant receives the intervention or not, the information we get from this study may help us to support people with dementia and their carers / supporters better in future.

Miss Melissa Melville
+44 300 300 1748
Melissa.melville@nelft.nhs.uk



The study is sponsored by North East London NHS Foundation Trust and funded by NIHR Central Commissioning Facility (CCF).



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Read full details for Trial ID: ISRCTN20868432

Or CPMS 57107

Last updated 04 December 2024

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