Evaluation of a New Cognitive Behavioral Therapy (CBT) to Reduce Psychological Distress and Improve Quality of Life of People With Alzheimer's Disease and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in severity of depression assessed by Patient Health Questionnaire (PHQ-9) (for patients with AD and caregivers)
研究概览
简要总结
Up to 70 % of people with dementia suffer from severe psychological distress that decreases their quality of life and that of their caregivers. A vicious circle can easily install between the person with Alzheimer's disease (AD) and her caregiver: the distress expressed by the person with AD increases burden of the caregiver who ends with distress, which in turn intensifies the distress of the person with AD.
In addition to disrupting the quality of life of people, psychological distress can also accelerate cognitive decline, caused by an increase in memory and attention problems. For all those reasons, it is indispensable to treat psychological distress in people with AD and their caregivers.
The project aims to test the feasibility and efficacy of a cognitive behavioral therapy (CBT) especially designed to reduce psychological distress and improve quality of life of people with AD and their caregivers and, possibly, to slow down cognitive decline.
详细描述
A large percentage of people with dementia (including Alzheimer's disease) suffer from psychological distress characterized by severe symptoms of anxiety, depression or insomnia. This psychological distress can disrupt their daily functioning and deteriorate their quality of life. The presence of anxiety, depression or insomnia can also accelerate cognitive decline in people with AD. Moreover, the psychological distress experienced by people with AD can have significant repercussions on their relatives. Effectively, up to 75 % of caregivers say they suffer from psychological distress due to the burden associated with their new role. The optimal treatment must therefore target the psychological distress experienced by people having AD and by their caregivers.
Cognitive behavioral therapy (CBT) is the psychological treatment of choice to treat anxiety, depression and insomnia in older people without cognitive impairment. However, few data are available to draw the same conclusions for people with dementia. In fact, only about ten studies on the subject have been published and many of them have poor methodological quality. The main methodological limitations identified in these studies are: 1) the lack of cognitive behavioral strategies treating simultaneously anxiety, depression and insomnia, three of the main symptoms of psychological distress; 2) the absence of active control groups and; 3) the absence of follow-ups exceeding 6 months. The current study will fill all these gaps by testing a new CBT named Programme de Bien-Être Psychologique (PEP) especially designed to improve the quality of life of people with AD and their caregivers.
The CBT will include 8 weekly group sessions of 120 minutes each. The first hour will be carried out in two simultaneous groups led each of them by a psychologist: a group of AD participants and a group of caregivers. The second half of the session will combine all the participants in one group and will be led by both psychologists. Each session will focus on the implementation of pleasant activities aimed at reducing psychological distress and improve the quality of life. Indeed, the loss of pleasant activities has been shown to be a leading cause of psychological distress (i.e., depression, anxiety, etc.) in people with cognitive impairment. Moreover, the content of the sessions will be adapted to the characteristics of people with AD. In particular, emotions management strategies (e.g. abdominal breathing) will be simplified to ensure proper understanding.
The CBT group will be compared to a non-directive support group. This active control group was developed in a similar format as the CBT group (in terms of the number of sessions, duration, etc.).
Objectives: The first objective is to assess the feasibility and efficacy of the Programme de Bien-Être Psychologique (PEP). It is expected that the PEP will have significantly more effect on psychological distress, level of functioning and participants' quality of life between pre and post intervention than the non-directive support group. It also hypothesized that participants assigned to the PEP intervention will be significantly more likely to maintain their progress at 6 and 12-month follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with AD who is currently at a mild to moderate stage (resulting in score between 0.5 to 2 on Clinical Dementia Rating).
- •Have a minimal self-criticism level to be able to participate in discussions during group therapy.
- •Get a score of at least 15 on the Kessler psychological Distress Scale (K10) (one of the two members of the dyad must meet this criterion).
- •Have a caregiver (minimum of 8 hours of direct contact per week) who wishes to participate in the study.
- •Be able to understand, read and speak French (this criterion applies to older adults with AD and caregivers).
排除标准
- •for patients and caregivers:
- •Presenting a psychiatric disorder that requires immediate care (e.g. psychotic disorder).
- •Have behavioral problems (e.g. excessive agitation) contraindicated for a group therapy.
- •Have a disability (e.g. severe vision loss), physical illness (e.g. severe arthritis) or neurodegenerative disease (e.g. multiple sclerosis) that could compromise participation in group therapy.
结局指标
主要结局
Change in severity of depression assessed by Patient Health Questionnaire (PHQ-9) (for patients with AD and caregivers)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Patient Health Questionnaire (PHQ-9) contains 9 items that identify the presence of depressive symptoms on a likert scale of 0 to 3. The addition of the scores makes it possible to estimate the severity of the depression. Total score ranges from 0 to 27. Higher scores indicate more severe depression.
Change in quality of sleep assessed by Insomnia Severity Index (ISI) (for patients with AD and caregivers)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Insomnia Severity Index (ISI) contains 7 items that measure the severity of insomnia and related concerns on a 5-point response scale. Total score ranges from 0 to 28. Higher scores indicate more severe insomnia.
Change in intensity of depressive symptoms assessed by Geriatric Depression Scale (GDS-15) (for patients with AD only)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Geriatric Depression Scale (GDS-15) contains 15 items that measure the intensity of depressive symptoms on a dichotomous scale (yes or no). Total score ranges from 0 to 15. Higher scores indicate higher levels of depressive symptoms.
Change in psychological distress assessed by Kessler Psychological Distress Scale (K10) (for patients with AD and caregivers)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Kessler Psychological Distress Scale (K10) contains 10 items that detect the presence of psychological distress during the last 4 weeks on a 5-point response scale. Total score ranges from 10 to 50. Higher scores indicate higher levels of psychological distress.
Change in severity of worries assessed by Abbreviated Penn State Worry Questionnaire (PSWQ-A) (for patients with AD and caregivers)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Abbreviated Penn State Worry Questionnaire (PSWQ-A) contains 8 items that measure the severity of worries on a 5-point response scale. Total score ranges from 8 to 40. Higher scores indicate more worries.
Change in intensity of anxious symptoms assessed by Geriatric Anxiety Inventory (GAI) (for patients with AD only)
时间窗: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
The Geriatric Anxiety Inventory (GAI) contains 20 items that measure the intensity of anxious symptoms on a dichotomous scale (agree or disagree). Total score ranges from 0 to 20. A score of 10 or over is associated with the presence of a generalized anxiety disorder (GAD).
次要结局
- Change in satisfaction with life assessed by Satisfaction with life 5-scale (SWLS) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in quality of life assessed by Quality of Life-Alzheimer's Disease (QOL-AD) (for patients with AD and caregivers)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in level of functioning assessed by Disability Assessment for Dementia (DAD) (for caregivers only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in pleasant activities assessed by a questionnaire from "Entrevue Profil du Loisir, version 4.0" (for patients with AD and caregivers)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in general cognitive functioning assessed by The Montreal Cognitive Assessment (MoCA) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in medication taken and support received (for patients with AD and caregivers)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in episodic memory assessed by Rey Auditory Verbal Learning Test (RAVLT) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in executive functions assessed by Frontal Assessment Battery (FAB) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in quality of life assessed by Short-Form Health Survey (SF-12) (for caregivers only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in language and semantic memory assessed by Boston Naming Test (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in sociovocational integration assessed by Community Integration Questionnaire (CIQ) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in language and semantic memory assessed by verbal fluency test (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in memory assessed by Famous Faces Test (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in executive functions assessed by Trail Making Test A and B (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in memory assessed by Self-evaluation Questionnaire (QAM-A) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in short-term memory assessed by digit span subtest from The Wechsler Memory Scale (WMS-III) (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in memory and visuocontructional praxis assessed by Rey-Osterrieth Complex Figure (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in executive functions assessed by Stroop-Victoria (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
- Change in visuoperceptive and visuospatial functions assessed by Clock drawings (for patients with AD only)(1-2 weeks before and after intervention, and 6-month and 12-month follow-ups)
研究者
Dr Sébastien Grenier
Research Associate Professor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal