Mindfulness Based Cognitive Therapy (MBCT) programme for depression in people with early stages of dementia
| ISRCTN | ISRCTN16382776 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16382776 |
| Protocol serial number | N/A |
| Sponsor | University of Oxford (UK) |
| Funder | University of Oxford (UK) |
- Submission date
- 18/07/2016
- Registration date
- 21/07/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and dementia are major public health problems in the UK. Depression is very common in people with early stage dementia and reduces quality of life and speeds up cognitive (mental) decline. Mindfulness-based cognitive therapy (MBCT) is an effective depression prevention programme. There have been promising results showing the benefits of mindfulness interventions for people with dementia, suggesting that it could reduce depressive symptoms and slow deterioration in cognitive functions. The aim of this study is to test the study design for a future full study to determine the effectiveness of MBCT at reducing depressive symptoms in people with early stage dementia.
Who can participate?
Patients with mild to moderate depression and early stages of dementia
What does the study involve?
Participants are randomly allocated to receive either immediate or delayed access to an eight-week MBCT programme. Participants are assessed for depression before and after the intervention.
What are the possible benefits and risks of participating?
Participants may benefit from the proposed treatment, which has very good evidence of its effectiveness for depression. There are no risks anticipated with participating in this study. Participants will be able to drop out at any stage if they wish to do so. If participants have any concerns following participation, they will be encouraged to use the contacts provided at information sheet.
Where is the study run from?
North East London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2016 to December 2017
Who is funding the study?
University of Oxford (UK)
Who is the main contact?
Dr Elisa Aguirre
Contact information
Public
Talking Therapies, Barking & Dagenham IAPT
NELFT
Waltham Forest Integrated Care Directorate
Church Elm Lane Health Centre
Church Elm Lane
Dagenham
RM10 9RR
United Kingdom
| 0000-0003-4096-5109 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mindfulness Based Cognitive Therapy (MBCT) programme for depression in people with early stages of dementia |
| Study acronym | N/A |
| Study objectives | The aim of this study is to recruit people experiencing mild to moderate depression who also have comorbid early stages of dementia. The research questions of the study are outlined below. Primary question: 1. Is the study design feasible - is it possible to identify this client group, recruit from memory services, randomise participants and collect data at baseline and follow up? Secondary questions: 1. To what extent will participants adhere to the intervention? 2. Is the MBCT satisfactory/acceptable to participants? 3. How many participants will be needed for a sufficiently powered future RCT? (efficacy data at follow up will be used for the future sample size estimation). |
| Ethics approval(s) | HRA London City and East REC, REC: 16/LO/0578 |
| Health condition(s) or problem(s) studied | Comorbid depression and early stages of dementia |
| Intervention | This is a feasibility study to test the possibility of delivering the MBCT intervention for people with mild to moderate depression and comorbid early stages of dementia. In this RCT, 50% of participants will be randomly allocated to the immediate group (IA) and will receive MBCT immediately. The remaining 50% of participants will be allocated to the delayed access control (DAC) group. Both arms will also receive treatment as usual. The primary end point will be follow up after the intervention. Monitoring will continue up to a 6-month final exit point. |
| Intervention type | Other |
| Primary outcome measure(s) |
Depression will be assessed using the Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos, Abrams, Young, & Shamoian, 1988), a 19 item clinician-administered instrument. Information is gathered from interviews with the participant and an informant (e.g. family memory, staff member) and this information is used to rate five areas of depression (mood-related signs, behavioural disturbance, physical signs, biological functions and ideational disturbance). Each item had a three-point scale (0=absent, 1 = mild or intermittent, 2 = severe) with scores ranging from 0-38. The clinical cut off for significant depressive symptoms was a score of 8 and above (Alexopoulos et al., 1988; Burns, 2002). The CSDD has good reliability and validity and it is deemed to be the ‘gold standard’ for assessing depressive symptoms in PWD (Sheehan, 2012). Measured at baseline, after intervention (3 months) and 6 months. |
| Key secondary outcome measure(s) |
Measured at baseline, after intervention (3 months) and 6 months: |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 32 |
| Key inclusion criteria | Participants will be recruited and identified from memory services in North East London NHS Foundation Trust and memory services in Oxleas Foundation Trust. Inclusion criteria: Treated or with a diagnosis of mild depression and a diagnosis of mild dementia according to DSM-IV criteria with a Mini Mental State Examination (MMSE) (Folstein et al., 1975) of 18 or above. |
| Key exclusion criteria | 1. Have congenital learning disability 2. Present with severe depression or high risk of self-harm (e.g. suicidal intent) requiring urgent intervention 3. Are within 2 months of a bereavement 4. Are involved in other psychosocial intervention research 5. Have a diagnosis of psychosis |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 01/09/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 31/05/2017 | 30/11/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/11/2020: Publication reference added.
18/10/2017: Internal review.