People with dementia experiencing difficulties with wellbeing, low mood, or depression Mental and Behavioural Disorders
Conditions
Interventions
A written behavioural activation (BA) based self-help intervention has been developed, based on existing BA based self-help interventions. The written material consists of two workbooks, one designed
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Person with Dementia Inclusion Criteria: 1. A probable diagnosis of dementia, in accordance with ICD-10 (World Health Organisation, 1992) or Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association, 1994) or DSM-5 (American Psychiatric Association, 2013) criteria for a dementia. 2. Mild to moderate dementia severity as defined by Mini-Mental State Examination (MMSE) scores of 12 to 24; 3. A score of 4 or more on the Geriatric Depression Scale (GDS-12R) 4. If participants are receiving antidepressant medication, they have been on a stable does for one month at baseline. 5. If participants taking acetyl-cholinesterase inhibitors or Memantine, they have been on a stable does for one month at baseline. 6. Residing at home 7. Sufficient proficiency in English to read and engage with the written BA self-help material. 8. Must have an informal carer (defined as a partner, family member or friend) who has regular contact (at least weekly) with the person with dementia. Informal Carer Inclusion Criteria 1. Aged 16 years or over 2. Self-identified informal carer of a person with dementia; 3. Has regular contact (at least weekly) with the person with dementia; 4. Willing to support the intervention, including increasing regular contact to facilitate supporting the intervention if required.
Exclusion criteria
Exclusion criteria: Person with Dementia Exclusion Criteria: 1. A score of above 24 or below 12 on the MMSE 2. A score of below 4 on the GDS-12R 3. A co-morbid diagnosis of post-traumatic stress disorder (PTSD), psychosis, type I and II bipolar disorder, personality disorder 4. Current alcohol abuse defined as use of alcohol so severe that it interferes with the person with dementia’s ability to perform normal activities in daily life and interfere with engagement with the intervention 5. Current abuse of either prescription or street drugs 6. Currently receiving formal psychotherapy 7. A reading impairment that would prevent the use of written BA self-help material 8. A score of 2 or more on Q9 of the PHQ-9 (Kroenke & Spitzer, 2002) indicating the participant is experiencing “thoughts that you would be better off dead or of hurting yourself in some way” for more than half the days over the proceeding fortnight 9. Acutely suicidal and / or a history of persistent self-injury Informal Carer Exclusion Criteria: 1. A score of 2 or more on Q9 of the PHQ-9 (Kroenke & Spitzer, 2002) indicating the participant is experiencing “thoughts that you would be better off dead or of hurting yourself in some way” for more than half the days over the proceeding fortnight 2. A score of 20 – 27 on the PHQ-9 indicating severe levels of depression 3. A diagnosis of post-traumatic stress disorder (PTSD), psychosis, type I and II bipolar disorder, personality disorder 4. Current alcohol abuse defined as use of alcohol so severe that it interferes with the carer’s ability to perform normal activities in daily life 5. Current use of either prescription medication in a non-prescribed manner or street drugs 6. Difficulties reading or following the written BA self-help material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measurements will mainly pertain to the feasibility aims of the study and will be assessed post-treatment (3 months). Specifically we are interested in examining the following: 1. Number of potential dyads (people with dementia and informal carer) that can be accessed per week 2. Response rates calculated for GP, PCPD and memory service recruitment 3. Identified barriers to recruitment 4. Percentage of dyads who complete the post-treatment (3 month) outcome measures 5. Time taken to administer the screening measures 6. Time taken to administer the baseline assessment 7. Time taken to administer the follow-up assessments 8. Acceptability of data collection procedures to people with dementia and informal carers 9. Clinician competence in terms of delivering the proposed intervention (levels of PWP competence and adherence to protocol as determined by therapy tapes) 10. We will also begin to explore barriers in terms of clinical delivery of the intervention. Feasibility study throughput (sample size) will allow an initial exploration of these factors however proper assessment will not be possible due to the small sample size. 10.1. Waiting list times 10.2. Session length 10.3. Number of sessions 10.4. Settings of sessions (BeMe, community, home) 10.5. Number of missed appointments 10.6. Number of missed outcome item measures 10.7. PWP attrition 10.8. Acceptability interviews with PWPs | — |
Secondary
| Measure | Time frame |
|---|---|
| Person with Dementia 1. Depressive symptoms measured by the CSDD and GDS-12R at baseline and 3 months 2. Quality of life measured by the DEMOL and EQ-5D-3L at baseline and 3 months Informal Carer 1. Depressive symptoms measured by the PHQ-9 at baseline and 3 months 2. Anxiety symptoms measured by the GAD-7 at baseline and 3 months 3. Carer Burden measured by the ZBI-12 at baseline and 3 months 4. Quality of life measured by the SF-12 and ES-5D-3L at baseline and 3 months 5. Health and public service used for both the person with dementia and informal carer measured by the adapted CSRI at baseline and 3 months | — |
Countries
United Kingdom
Contacts
Public ContactJoanne Woodford
Outcome results
None listed