ISRCTN42017211已完成未知
Behavioural activation written self-help to improve mood, well-being and quality of life in people with dementia supported by informal carers (the PROMOTE study): a feasibility study
niversity of Exeter0 个研究点目标入组 100 人开始时间: 2015年8月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2016 protocol in https://pubmed.ncbi.nlm.nih.gov/27965860/ (added 10/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
相似试验
已完成
不适用
A self-management programme of activity coping and education - SPACE FOR COPD - in primary care: a pragmatic trialChronic obstructive pulmonary disease (COPD), self managementRespiratoryChronic obstructive pulmonary disease, unspecifiedISRCTN17942821eicester General Hospital (UK)193
已完成
不适用
Win Back Control: a gambling self-help toolProblematic gamblingMental and Behavioural DisordersISRCTN16339434Research Institute for Public Health and Addiction (ISGF)360
已完成
不适用
A people-centred approach through Self-Management and Reciprocal learning for the prevention and management of Type 2 DiabetesISRCTN11913581European Commission712
已完成
不适用
Improving the management of behaviour that challenges associated with dementia in care homes: testing the feasibility of a combined pharmacy-health psychology interventioMental and Behavioural DisordersDementiaISRCTN58330068Aston University34
进行中（未招募）
不适用
Augmenting an online self-directed intervention for gambling disorder with a single motivational interviewGambling disorderMental and Behavioural DisordersISRCTN13009468niversity of Calgary322