Mindfulness Based Cognitive Therapy (MBCT) programme for depression in people with 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. CONDITION: Comorbid depression and early stages of dementia ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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 depression; ; 4. Quality of Life ‐ Alzheimer's Disease Scale: Participant Version (QoL AD). Quality of life will be measured using the Quality of Life – Alzheimer's Disease scale (QoL‐AD) (Logsdon, 1999), a 13‐item self‐report questionnaire. Information about several areas was gathered from the PWD and their carer, such as physical health, mood, friends, fun, self and general life. The measure has excellent internal consistency and inter‐rater reliability. The content, criterion and construct validity are good (Logsdon, 1999).; ; 5. Cognitive Affective Mindfulness Scale (CAMS‐R). The Cognitive Affective Mindfulness Scale (Revised) (CAMS‐R; Feldman, Hayes, Kumar, Greeson & Laurenceau, 2007) is a 12‐item self‐report questionnaire that measures trait mindfulness in day‐to‐day experience. Scores range between 0‐48, with higher scores indicating higher levels of mindfulness. Each item (e.g. ‘I try to notice my thoughts without judging them’) is rated on a four‐point scale of 1 (‘rarely/not at all’), 2 (‘sometimes’), 3 (‘often’) or 4 (‘almost always’). The measure was used in the aforementioned pilot study (Chan, 2015; Churcher‐Clarke, 2015a, unpublished) in people with dementia.; ; 6. Generalized Anxiety Disorder 7‐item (GAD‐7) scale (Spitzer, 2007). The GAD‐7 is a seven‐item questionnaire focusing on symptoms of anxiety experienced in the past 2 weeks. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0?=?'not at all', 1?=?'several days', 2?=?'more than half the days', 3?=?'nearly every day'. Therefore, the maximum score is 21. Scores of 0–5 indicate mild anxiety, 6–10?=?moderate anxiety, 11–15 moderately severe anxiety and 15–21 severe anxiety.; ; 7. Rating Anxiety in Dementia (RAID). Anxiety will be assessed using the Rating Anxiety in Dementia (RAID) scale (Shankar, Walker, Frost, & Orrell, 1999), an 18‐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 four areas of anxiety (worry, apprehension, vigilance, motor tension, autonomic hypersensitivity). Each item is rated on a four‐point scale (0=absent, 1 = mild or intermittent, 2 = moderate, 3= severe) with scores ranging from 0‐54. The clinical cut off for significant clinical anxiety was a score of 11 and above. The RAID is the most appropriate measure for assessing anxiety in PWD (Seignourel, Kunik, Snow, Wilson, & Stanley, 2008).; ; 8. Control, Autonomy, Self‐realisation and Pleasure (CASP‐19); 9. Positive Psychology Outcome Measure (PPOM); 10. Engagement and Independence in Dementia Questionnaire (EID‐Q); 11. Cognitive mediation questionnaire (Dagnan and Chadwick 1997); 12. Thought, feeling behaviour questionnaire (Oathamshaw and Haddock 2006).; ; We are currently in discussions about which of these measures are best to use. We will pilot how long measures we can complete in 90 minutes.; ; Weekly measures; PHQ‐9, GAD‐7 and CSDD will be collected after each mindfulness session, in line with the service protocol.; ; Carer measures; This will be conducted by the assessor in a private room in the memory clinic or in the participants home. The assessor will ask a member of staff or family member questions about the relevant participant's, mood, anxiety and quality of life. The information obtained will be used in combination with the information gathered from the interview with the participant to complete the following assessments:; 1. Cornell Scale for Depression in Dementia (Alexopoulos, Abrams, Young and Shamoian, 1988); 2. Quality of Life Alzheimer's Disease Scale: Carer Version (QoL‐AD, Logsdon, Gibbons, McCurry and Terri, 1999); 3. Rating Anxiety in Dementia (carer version) 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.