Mindfulness Based Cognitive Therapy (MBCT) programme for depression in people with early stages of dementia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16382776

Enrollment

Registered

2016-07-21

Start date

2016-06-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comorbid depression and early stages of dementia Mental and Behavioural Disorders

Interventions

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 participa

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Measured at baseline, after intervention (3 months) and 6 months: 1. Mini Mental State Examination (MMSE). Cognitive function will be measured by the Mini Mental State Exam (MMSE) (Folstein et al., 1975). This will be used as an outcome measure and a screening tool for inclusion. The MMSE involves the participant doing 11 simple tasks, such as orientation to time and place, attention, recall, language and visual construction. The MMSE is an extremely widely used tool for assessing cognition in dementia (Woodford & George, 2007). 2. Cornell Scale for Depression in Dementia (CSDD). 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). 3. Patient Health Questionnaire (PHQ-9). PHQ-9 is a freely available mood rating questionnaire consisting of nine questions mirroring DSM-IV depression diagnostic criteria and each rated 0–3 giving a maximum score of 27. Cut-off scores are used to label depression severity as: 3.1. 0–4: minimal depression 3.2. 5–9: mild depression 3.3. 10–14: moderate depression 3.4. 15–19: moderately severe depression 3.5. 20–27: severe depressi	—

Measure

Time frame

Measured at baseline, after intervention (3 months) and 6 months: 1. Mini Mental State Examination (MMSE). Cognitive function will be measured by the Mini Mental State Exam (MMSE) (Folstein et al., 1975). This will be used as an outcome measure and a screening tool for inclusion. The MMSE involves the participant doing 11 simple tasks, such as orientation to time and place, attention, recall, language and visual construction. The MMSE is an extremely widely used tool for assessing cognition in dementia (Woodford & George, 2007). 2. Cornell Scale for Depression in Dementia (CSDD). 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). 3. Patient Health Questionnaire (PHQ-9). PHQ-9 is a freely available mood rating questionnaire consisting of nine questions mirroring DSM-IV depression diagnostic criteria and each rated 0–3 giving a maximum score of 27. Cut-off scores are used to label depression severity as: 3.1. 0–4: minimal depression 3.2. 5–9: mild depression 3.3. 10–14: moderate depression 3.4. 15–19: moderately severe depression 3.5. 20–27: severe depressi

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Countries

United Kingdom

Contacts

Public ContactElisa Aguirre

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026