Compassion focused therapy - for mood in dementia
| ISRCTN | ISRCTN20868432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20868432 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 327086 |
| Central Portfolio Management System (CPMS) | 57107 |
| National Institute for Health and Care Research (NIHR) | 203524 |
| Sponsor | North East London NHS Foundation Trust |
| Funder | NIHR Central Commissioning Facility (CCF) |
- Submission date
- 16/08/2023
- Registration date
- 21/08/2023
- Last edited
- 26/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
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 is a talking therapy which addresses feelings of shame and stigma. Our team tested Compassion Focused Therapy 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 Compassion Focused Therapy in the form of a randomised controlled trial, following encouraging results from our feasibility study. Participants will be randomly allocated to either the intervention (twelve sessions of group Compassion Focused Therapy, delivered online or face-to-face) or the control group (usual care only). 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. These will be assessed at the start of the study, after the intervention, and at the 6-month follow-up. We will also explore participants’ preferences for how the therapy is delivered, differences between online and face-to-face groups, and factors that may influence how well the intervention works.
This randomised controlled trial builds directly on our earlier feasibility study, with that data included as part of the final analysis. Our aim is to see whether Compassion-Focused Therapy helps people with dementia who are experiencing low mood and whether it is a cost-effective approach.
Who can participate?
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 Compassion Focused Therapy groups, OR the ability to attend a face-to-face group
6. Are not participating in another interventional research programme concurrently
7. Have sufficient hearing to engage in group discussions (with or without hearing aids)
8. Aged 18 years and over
9. People can be included whether or not they have a caregiver
What does the study involve?
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 Compassion Focused Therapy 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 programme. 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 person receiving therapy in between sessions.
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, and 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:
1. 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.
2. Meet with a researcher again after the 12 Compassion-Focused Therapy 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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Recruitment will primarily take place through the NHS Foundation Trusts of North East London, Oxford Health, Norfolk and Suffolk, Black Country Healthcare, Central and North West London, Lincolnshire Partnership, Cheshire and Wirral Partnership and Devon Partnership. We will also recruit through ‘Join Dementia Research’, an online recruitment platform.
When is the study starting and how long is it expected to run for?
November 2023 to October 2028
Who is funding the study?
National Institute for Health and Research, the Research for Patient Benefit Programme (UK)
Who is the main contact?
Melissa Melville, Melissa.melville@nelft.nhs.uk
Contact information
Scientific
North East London Foundation Trust
Research and Development Department
1st Floor Maggie Lilley Suite
Goodmayes Hospital
Barley Lane
Ilford
IG3 8XJ
United Kingdom
| Phone | +44 300 300 1748 |
|---|---|
| Melissa.melville@nelft.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 44126 PIS v2.0 08Aug2023.pdf |
| Scientific title | Being kind to ourselves: A randomised controlled trial of compassion focused therapy (CFT) to improve symptoms of depression and anxiety in dementia |
| Study objectives | Secondary study objectives: The aims/objectives will be to: 1. Evaluate the efficacy of CFT in improving depression (primary outcome, measured by the Cornell Scale for Depression in Dementia, anxiety, quality of life, cognition, self-compassion, and the caregiver-patient relationship in people with dementia, compared to TAU; at 16 weeks and 6 months. 2. Evaluate caregiver burden and caregiver perception of the caregiver-patient relationship (if caregiver is available to participate), compared to TAU, at 16 weeks and 6 months. 3. Assess the cost-effectiveness of group CFT compared to TAU at 16 weeks by estimating the incremental cost per ‘Quality Adjusted Life Year’ (QALY) gained. 4. Explore: 4.1. Differences in outcomes between face-to-face and online groups 4.2. Participants’ preferences for delivery format and 4.3. Potential predictors of success in the intervention (such as baseline mood, cognitive impairment, engagement (or not) of a caregiver and demographic factors) as part of a secondary, exploratory analysis. Previous study objectives: As this is an unpowered feasibility study, we are not hypothesising significant changes in any outcomes. However, we will explore changes in outcomes pre- and post-intervention, comparing the treatment and control groups (TAU), and may expect some positive trends. We are also exploring the differences between online and f2f groups and have no current hypothesis in terms on superiority. The main objectives of the study are: 1. To undertake a feasibility Randomised Controlled Trial (RCT) to assess critical elements of a full RCT of Compassion Focused Therapy (CFT) in dementia. These include eligibility rates, recruitment and attrition rates, data collection and intervention delivery; 2. To establish acceptability of CFT as an online or face-to-face intervention for people with dementia; 3. To assess intervention fidelity; 4. To establish preliminary intervention efficacy; 5. To establish suitability of study outcome measures including cost-effectiveness measures; 6. To gather data to inform the decision of the primary outcome for a full RCT and obtain estimates of parameters to inform the calculation of the required sample size for a full RCT; 7. To use qualitative and quantitative findings to modify the treatment manual (if required). |
| Ethics approval(s) |
Approved 11/08/2023, London Riverside (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 20 7104 8150; riverside.rec@hra.nhs.uk), ref: 23/LO/0535 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Current interventions as of 26/03/2026: This will be a single-blind randomised controlled trial of group CFT versus treatment as usual (TAU). 304 participants will be randomised to either the intervention group or control group (TAU). Randomisation will occur after baseline assessments are completed. Where possible, assessments will be collected by a researcher who is blind to group allocation. Assessments will be delivered virtually or face-to-face, depending on patient preference. Demographics and general information will be collected including age, gender, ethnic group, use of medication (including antidepressants, anxiolytics and cholinesterase inhibitors), treatment preference, participation in other activities and presence / absence of a carer/ supporter. Baseline assessments will include measures of quality of life, symptoms of depression and symptoms of anxiety, a measure of self-compassion, cognitive function, resource use, relationship with caregiver and caregiver burden (if applicable). Each arm will have approximately 150 participants and they will be allocated to one CFT group with up to 7 participants in each group. The duration of the intervention will be 15 weeks, consisting of 12 CFT therapy sessions. Given that it can prove difficult to always fit the 12 sessions into 12 consecutive weeks (due to factors such as weather issues, therapist annual leave, strikes, illness), the additional 3 weeks provides a buffer and may increase the likelihood that participants could receive all 12 sessions. There will be assessments at baseline during the week prior to randomisation, and at the end of the intervention at 16 weeks and at 6 months follow-up. Twelve, 60-minute virtual or face-to-face group CFT sessions including three phases. Phase 1 involves setting up and introducing CFT including psychoeducation on emotion regulation systems, formulation and goal setting. Phase 2 teaches people techniques to develop self-compassion, including imagery and the writing of compassionate letters. Phase 3 teaches techniques to tolerate difficult feelings, focusing on ending and maintaining benefits. Sessions will include a core CFT practice, for example ‘soothing rhythm breathing’ which involves slowing and deepening the breath. Each session will introduce a new concept, such as the qualities of compassion, mindful awareness and understanding the function of self-criticism. There will be time to reflect on the emotional experience of living with dementia, e.g., how the diagnosis can be experienced as a ‘threat’ to the self and future, triggering fear, anxiety and disconnection. Sessions will end with suggesting home practices, with participants given session summaries. CFT will be adapted to compensate for cognitive changes, including frequent repetition and use of visual and verbal information. Building on the experience of running CST groups, groups will consist of approximately five people. We will factor in time for social interaction before and after the session, either virtually or face-to-face. Additional carer/supporter workshop: we will run a brief workshop (flexibility for online or face-to-face) for primary carers/supporters (if available) towards the beginning of the CFT programme. This will educate carers on the principles of CFT, providing an outline of what we intend to do in the sessions and giving people tips on what can be done at home to encourage and support the therapy (for example, reminding the person to do breathing or relaxation exercises). The intervention group will continue to have access to their usual care, which includes input from health and social care professionals, anti-dementia medication and their usual day activities. Control group: Defined as standard treatment available to people with dementia and depression and/or anxiety, which might include medication, other therapies, day care, input from health and social care professionals such as psychiatrists, psychologists and social workers or no treatment. We will collect information on all health and care services used by people with dementia (which we can compare with ongoing observational studies such as IDEAL) to describe what TAU involves for each participant; this can be taken into account in a future, fully powered trial. As both groups will have access to TAU, this study will look at the additional impact of CFT. For those who do not own a tablet and wish to complete the online intervention, ten tablets will be purchased and lent to those participants, aiming to maximise inclusivity. Previous interventions: This will be a single blind, feasibility randomised controlled trial of group CFT versus treatment as usual (TAU). Fifty participants will be randomised to either the intervention group or control group (TAU). Randomisation will occur after baseline assessments are completed. Where possible, assessments will be collected by a researcher who is blind to group allocation. Assessments will be delivered virtually or face-to-face, depending on patient preference. Demographics and general information will be collected including age, gender, ethnic group, use of medication (including antidepressants, anxiolytics and cholinesterase inhibitors), treatment preference, participation in other activities and presence / absence of a carer/ supporter. Baseline assessments will include measures of quality of life, symptoms of depression and symptoms of anxiety, a measure of self-compassion, cognitive function, resource use, relationship with caregiver and caregiver burden (if applicable). Each arm will have approximately 25 participants and they will be allocated to one CFT group with up to 5 participants in each group. The duration of the intervention will be 15 weeks, consisting of 12 CFT therapy sessions. Given that it can prove difficult to always fit the 12 sessions into 12 consecutive weeks (due to factors such as weather issues / therapist annual leave, strikes, illness), the additional 3 weeks provides a buffer and may increase the likelihood that participants could receive all 12 sessions. There will be assessments at baseline during the week prior to randomisation, and at the end of the intervention at 16 weeks and at 6 months follow-up. Twelve, 60-minute virtual or face-to-face group CFT sessions including three phases. Phase 1 involves setting up and introducing CFT including psychoeducation on emotion regulation systems, formulation and goal setting. Phase 2 teaches people techniques to develop self-compassion, including imagery and the writing of compassionate letters. Phase 3 teaches techniques to tolerate difficult feelings, focusing on ending and maintaining benefits. Sessions will begin with a core CFT practice, for example ‘soothing rhythm breathing’ which involves slowing and deepening the breath. Each session will introduce a new concept, such as the qualities of compassion, mindful awareness and understanding the function of self-criticism. There will be time to reflect on the emotional experience of living with dementia, e.g., how the diagnosis can be experienced as a ‘threat’ to the self and future, triggering fear, anxiety and disconnection. Sessions will end with suggesting home practices, with participants given session summaries. CFT will be adapted to compensate for cognitive changes, including frequent repetition and use of visual and verbal information. Building on the experience of running CST groups, groups will consist of approximately five people. We will factor in time for social interaction before and after the session, either virtually or face-to-face. Additional carer/supporter workshop: we will run a brief workshop (flexibility for online or face-to-face) for primary carers/supporters (if available) towards the beginning of the CFT programme. This will educate carers on the principles of CFT, providing an outline of what we intend to do in the sessions and giving people tips on what can be done at home to encourage and support the therapy (for example, reminding the person to do breathing or relaxation exercises). The intervention group will continue to have access to their usual care, which includes input from health and social care professionals, anti-dementia medication and their usual day activities. Control group: Defined as standard treatment available to people with dementia and depression and/or anxiety, which might include medication, other therapies, day care, input from health and social care professionals such as psychiatrists, psychologists and social workers or no treatment. We will collect information on all health and care services used by people with dementia (which we can compare with ongoing observational studies such as IDEAL) to describe what TAU involves for each participant; this can be taken into account in a future, fully powered trial. As both groups will have access to TAU, this study will look at the additional impact of CFT. For those who do not own a tablet and wish to complete the online intervention, ten tablets will be purchased and lent to those participants, aiming to maximise inclusivity. Qualitative interviews will be used to gather participant, carer/supporter and clinician perspectives on the value, acceptability and feasibility of the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcomes as of 26/03/2026: |
| Key secondary outcome measure(s) |
Current secondary outcomes as of 26/03/2026: |
| Completion date | 31/10/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 304 |
| Key inclusion criteria | Current inclusion criteria as of 26/03/2026: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the following: 2.1. A confirmed dementia diagnosis based on DSM-IV criteria for any type of dementia, AND 2.2. A Clinical Dementia Rating (CDR) score of 0.5, 1, or 2 (Morris, 1997). 3. Experience symptoms of depression and/or anxiety as determined by either: 3.1. A HADS score ≥ 8 on the anxiety and/or depression subscale (Zigmond & Snaith, 1983), OR 3.2. A HADS score of 5–7, accompanied by evidence of low mood as reported by a caregiver or clinician, OR 3.3. Significant psychological distress, as assessed by a clinician or researcher, regardless of the HADS score. 4. Have capacity to consent to take part in research 5. Can communicate in English 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group 7. Are not participating in another interventional research programme concurrently 8. Have sufficient hearing to engage in group discussions (with or without hearing aids). 9. Aged 18 years and over 10. People can be included whether or not they have a caregiver. Previous inclusion criteria as of 05/09/2024: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the Clinical Dementia Rating (CDR) 3. Experience symptoms of depression and/or anxiety (8 ≥) as measured by the Hospital Anxiety and Depression Scale (HADS) OR a minimum score of 5 and experience of depression and/or anxiety as reported by either the caregiver or clinician 4. Have capacity to consent to take part in research 5. Can communicate in English 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group 7. Are not participating in another interventional research programme concurrently 8. Aged 18 years and over 9. People can be included whether or not they have a caregiver. Original inclusion criteria: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the Clinical Dementia Rating (CDR) 3. Experience symptoms of depression and/or anxiety (8 > = ) as measured by the Hospital Anxiety and Depression Scale (HADS); 4. Have capacity to consent to take part in research; 5. Can communicate in English, 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group; 7. Are not participating in another interventional research programme concurrently. 8. Aged 18 years and over 9. People can be included whether or not they have a caregiver. |
| Key exclusion criteria | 1. Communication is significantly impaired by cognitive decline 2. Unable to speak English 3. 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. |
| Date of first enrolment | 08/11/2023 |
| Date of final enrolment | 30/09/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
England
Warneford Lane
Headington
Oxford
OX3 7JX
England
Norwich
NR6 5BE
England
Dudley
DY2 8PS
England
350 Euston Road
Regents PLACE
London
NW1 3AX
England
Long Leys Road
Lincoln
LN1 1FS
England
The Countess of Chester Health Park
Liverpool Road
Chester
CH2 1BQ
England
Dryden Road
Exeter
EX2 5AF
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Professor Aimee Spector (aimee.spector@nelft.nhs.uk). The data will be pseudonymised and uploaded into a repository. Professor Spector will consult with NELFT as the sponsor on a case-by-case basis regarding each data request received. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/12/2024 | 04/12/2024 | Yes | No | |
| Participant information sheet | version 2.0 | 08/08/2023 | 17/08/2023 | No | Yes |
| Participant information sheet | version 3.0 | 04/10/2023 | 05/09/2024 | No | Yes |
| Participant information sheet | version 1.0 | 02/02/2026 | 26/03/2026 | No | Yes |
| Participant information sheet | version 1.0 | 02/02/2026 | 26/03/2026 | No | Yes |
| Protocol file | version 2.0 | 09/08/2023 | 21/08/2023 | No | No |
| Protocol file | version 7.0 | 27/08/2024 | 05/09/2024 | No | No |
| Protocol file | version 12 | 21/01/2026 | 26/03/2026 | No | No |
Additional files
- 44126 PIS v2.0 08Aug2023.pdf
- Participant information sheet
- 44126 CFT_Protocol_V2.0_09.08.23.pdf
- Protocol file
- ISRCTN20868432_Protocol_V7.0_27Aug2024.pdf
- Protocol file
- ISRCTN20868432_PIS_V3.0_04Oct2023.pdf
- Participant information sheet
- ISRCTN20868432_PROTOCOL_V12_21Jan2026.pdf
- Protocol file
- ISRCTN20868432_PIS_CarerSupporter_V1.0_02Feb2026.pdf
- Participant information sheet
- ISRCTN20868432_PIS_Participant_V1.0_02Feb2026.pdf
- Participant information sheet
Editorial Notes
26/03/2026: The following changes were made to the study record:
1. The protocol and participant information sheets were uploaded.
2. The plain English summary, study objectives, primary and secondary outcomes, inclusion criteria and study participating centres were updated.
3. The scientific title was changed from 'Being kind to ourselves: A feasibility randomised controlled trial of compassion focused therapy (CFT) to improve depression and anxiety in dementia' to 'Being kind to ourselves: A randomised controlled trial of compassion focused therapy (CFT) to improve symptoms of depression and anxiety in dementia'.
4. The target sample size was changed from 50 to 304.
5. The date of final enrolment was changed from 01/02/2025 to 30/09/2027.
6. The completion date was changed from 01/10/2025 to 31/10/2028.
04/12/2024: Publication reference added.
12/09/2024: The sponsor contact was updated.
05/09/2024: The following changes were made:
1. The patient information sheet (version 3.0) was uploaded.
2. Protocol (version 7.0 not peer-reviewed) uploaded.
3. The participant inclusion criteria were updated.
4. Mersey Care NHS Foundation Trust was removed from the study participating centres.
5. Norfolk and Suffolk NHS Foundation Trust, Black Country Healthcare NHS Foundation Trust, Central and North West London NHS Foundation Trust, Lincolnshire Partnership NHS Foundation Trust and Cheshire and Wirral Partnership were added to the study participating centres.
6. The plain English summary was updated to reflect these changes.
06/11/2023: The recruitment start date was changed from 18/10/2023 to 08/11/2023.
02/10/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 25/09/2023 to 18/10/2023.
2. The participant level data sharing statement was added.
04/09/2023: The recruitment start date was changed from 04/09/2023 to 25/09/2023.
16/08/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
