Evaluation of a New CBT for People With Alzheimer's Disease and Their Caregivers

NCT03656159 | Completed DMC

• 1 other identifier: CRIUGM-006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Cognitive-Behavioral Therapy (CBT); Psychological Intervention; Older adults; Caregivers

Outcome Measures

Primary Outcomes (6)

• Change in psychological distress assessed by Kessler Psychological Distress Scale (K10) (for patients with AD and caregivers)

  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.

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

• Change in intensity of anxious symptoms assessed by Geriatric Anxiety Inventory (GAI) (for patients with AD only)

  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).

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

• Change in severity of worries assessed by Abbreviated Penn State Worry Questionnaire (PSWQ-A) (for patients with AD and caregivers)

  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.

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

• Change in intensity of depressive symptoms assessed by Geriatric Depression Scale (GDS-15) (for patients with AD only)

  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.

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

• Change in severity of depression assessed by Patient Health Questionnaire (PHQ-9) (for patients with AD and caregivers)

  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.

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

• Change in quality of sleep assessed by Insomnia Severity Index (ISI) (for patients with AD and caregivers)

  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.

  1-2 weeks before and after intervention, and 6-month and 12-month follow-ups

Secondary Outcomes (19)

• 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 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 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 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 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

Study Arms (2)

Non-directive support group

ACTIVE COMPARATOR

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.

Behavioral: Non directive support Group

Cognitive-Behavioral group therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-Behavioral group therapy

Interventions

Cognitive-Behavioral group therapy BEHAVIORAL

Intervention will consist of eight weekly sessions of two hours each with a break of 15 minutes. The CBT will be delivered by a clinical psychologist and a clinical neuropsychologist previously trained in this therapeutic approach.

Cognitive-Behavioral group therapy

Non directive support Group BEHAVIORAL

Intervention will consist of eight weekly sessions of two hours each with a break of 15 minutes. The support group will be delivered by Ph.D. students having no experience with CBT.

Non-directive support group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Sébastien Grenier: lead
• Alzheimer Society of Canada: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Montreal, Quebec, H3W 1W5, Canada

Location

Related Links

• lab website (in French only)

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sébastien Grenier, Ph.D.

  Centre de recherche de l'Institut universitaire de gériatrie de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: September 4, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CA (1)