Behavioural activation self-help for well-being in people with dementia

Not Applicable

Completed

• Conditions: People with dementia experiencing difficulties with wellbeing, low mood, or depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN42017211
• Lead Sponsor: niversity of Exeter

Brief Summary

2016 protocol in https://pubmed.ncbi.nlm.nih.gov/27965860/ (added 10/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-27
• Study Completion: 2016-10-10
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified