Clinical trial NCT03656159: Evaluation of a New CBT for People With Alzheimer's Disease and Their Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Cognitive-Behavioral Therapy (CBT)
Psychological Intervention
Older adults
Caregivers
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Alzheimer Society of Canada
name: Université de Montréal
First posted: 2018-09-04
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The second objective is to test if the PEP intervention can slow down cognitive decline in participants with AD. It is expected that the intervention will be significantly more effective in slowing cognitive decline between pre-test and follow-ups compared to the non-directive support group.

The last objective is to survey the participants' opinion after the treatment to deepen the quantitative results.

Recruitment: 30 dyads of French-speaking participants will be recruited in Montreal from the cognition clinic of the IUGM, in the CRIUGM participants' database and among a number of community organizations working with seniors and caregivers. In addition, ads will be published in newsletters sent by local community organizations to their membership base, as well as ads placed in newspapers or magazines destined to the elderly population. Dyads wishing to participate will have to contact the research coordinator or will be contacted if consent has been given. In both cases, a phone interview will determine the eligibility of the dyads to participate in the study.

Eligible dyads will be then invited to complete the pretest. It will begin with a physician's assessment to confirm the diagnosis of AD and assess its severity with the Clinical Dementia Rating (CDR). In addition, the physician will assess the level of self-criticism of the person with AD to ensure that he/she is aware of his/her memory losses (see inclusion criteria). After, questionnaires assessing psychological health and quality of life will be administered to participants with AD and their caregivers (on an individual basis) by two students in psychology. A second assessment session will be taken in charge by a doctoral student in neuropsychology who will evaluate the cognitive status of people with AD using different neuropsychological tests.

After the two assessment sessions, eligible participants will be randomly assigned to either the PEP intervention (i.e. experimental group) or the non-directive support group (i.e. control group). They will be matched by gender, age, level of self-criticism, clinical dementia rating (CDR) scores, and intensity of psychological distress (K10).

With the exception of the physician's assessment, psychological and neuropsychological questionnaires will be administered again at post-intervention (T2) and at 6 (T3) and 12 months (T4) follow-ups. Moreover, booster sessions will be scheduled 6 and 12 months after the intervention. Finally, all dyads will be contacted monthly by phone during the year following the intervention. These follow-ups will be done to help reduce the attrition rate and to maintain therapeutic gains. All participants will be enrolled in the study for a period of 15 months.

The intervention: The CBT intervention (i.e., PEP group) is a modified version of one previously developed by Grenier and Ouellet for participants having mild cognitive impairment (MCI).This intervention has been manualized. Basically, the intervention will include behavioral activation, cognitive restructuring, and stress/anger management strategies (e.g. abdominal breathing, progressive muscle relaxation). In addition, knowledge about memory management and sleep disorders will be provided. The components of CBT will be adapted to people with AD by including easy instructions, repetition of information during and between sessions, visual support, practice during sessions and a comprehensive summary of each session.

The non-directive support group: This intervention will provide time and space to discuss the impact of AD. The objective will be to help participants feel less alone and better understood and to address the implications of AD in their daily life. The animators will facilitate the exchange of opinions and encourage discussions through questions or suggestions without teaching CBT strategies.

Eligibility criteria: Inclusion criteria:

1. 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).
2. Have a minimal self-criticism level to be able to participate in discussions during group therapy.
3. 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).
4. Have a caregiver (minimum of 8 hours of direct contact per week) who wishes to participate in the study.
5. Be able to understand, read and speak French (this criterion applies to older adults with AD and caregivers).

Exclusion criteria for patients and caregivers:

1. Presenting a psychiatric disorder that requires immediate care (e.g. psychotic disorder).
2. Have behavioral problems (e.g. excessive agitation) contraindicated for a group therapy.
3. 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.

Primary outcomes:
measure: Change in psychological distress assessed by Kessler Psychological Distress Scale (K10) (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in intensity of anxious symptoms assessed by Geriatric Anxiety Inventory (GAI) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in severity of worries assessed by Abbreviated Penn State Worry Questionnaire (PSWQ-A) (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in intensity of depressive symptoms assessed by Geriatric Depression Scale (GDS-15) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in severity of depression assessed by Patient Health Questionnaire (PHQ-9) (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in quality of sleep assessed by Insomnia Severity Index (ISI) (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
Secondary outcomes:
measure: Change in level of functioning assessed by Disability Assessment for Dementia (DAD) (for caregivers only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in quality of life assessed by Quality of Life-Alzheimer's Disease (QOL-AD) (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in quality of life assessed by Short-Form Health Survey (SF-12) (for caregivers only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in satisfaction with life assessed by Satisfaction with life 5-scale (SWLS) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in pleasant activities assessed by a questionnaire from "Entrevue Profil du Loisir, version 4.0" (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in medication taken and support received (for patients with AD and caregivers)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in sociovocational integration assessed by Community Integration Questionnaire (CIQ) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in general cognitive functioning assessed by The Montreal Cognitive Assessment (MoCA) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in language and semantic memory assessed by Boston Naming Test (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in language and semantic memory assessed by verbal fluency test (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in episodic memory assessed by Rey Auditory Verbal Learning Test (RAVLT) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in memory assessed by Famous Faces Test (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in memory assessed by Self-evaluation Questionnaire (QAM-A) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in short-term memory assessed by digit span subtest from The Wechsler Memory Scale (WMS-III) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in memory and visuocontructional praxis assessed by Rey-Osterrieth Complex Figure (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in executive functions assessed by Frontal Assessment Battery (FAB) (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in executive functions assessed by Trail Making Test A and B (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in executive functions assessed by Stroop-Victoria (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
measure: Change in visuoperceptive and visuospatial functions assessed by Clock drawings (for patients with AD only)
timeFrame: 1-2 weeks before and after intervention, and 6-month and 12-month follow-ups
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut universitaire de gériatrie de Montréal
name: Sébastien Grenier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: