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Mindfulness Research Program: Designed to Enhance Wellbeing in People Living With Dementia and Their Spouses (MBCT_AD)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy
Sponsored by
Lakehead University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Dementia, Spouse Caregiver, Depression, Mind Body Therapy, Cognitive Therapy, Quality of Life, Attention, Memory

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Early stages of dementia
  • Spousal caregiver (no signs of dementia/mild cognitive impairment)
  • Evidence of at least mild depression (in at least one partner)
  • Speak, read, and write in English

Exclusion Criteria:

  • Neurological Disorder (other than dementia for dementia group)
  • Psychological Disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Waitlist Control

    Mindfulness-Based Cognitive Therapy

    Arm Description

    Participants in the control group will undergo a non-intervention 8-week period while on the 'waitlist control' then will be crossed-over to the Mindfulness-Based Cognitive Therapy intervention.

    Mindfulness-Based Cognitive Therapy is an 8-week intervention, one session per week for 2 hours, where participants will learn and practice formal and informal mindfulness meditation, and participate in group discussion and inquiry.

    Outcomes

    Primary Outcome Measures

    Change in Depression Symptoms
    Change score on Geriatric Depression Scale: Change from pre-intervention baseline depression symptoms (Week 1) at post-intervention (Week 10).

    Secondary Outcome Measures

    Change in Apathy Levels
    Change score on Apathy Evaluation Scale: Change from pre-intervention baseline apathy levels (Week 1) at post-intervention (Week 10).
    Change in Quality of Life
    Change score on Quality of Life-AD Scale: Change from pre-intervention baseline quality of life (Week 1) at post-intervention (Week 10).
    Change in Anxiety Levels
    Change score on Depression, Anxiety and Stress Scale: Change from pre-intervention baseline anxiety symptoms (Week 1) at post-intervention (Week 10).
    Change in Levels of Coping
    Change score on the Brief COPE: Change from pre-intervention baseline levels of coping (Week 1) at post-intervention (Week 10).
    Change in Burden Levels
    Change score on Zarit Burden Inventory: Change from pre-intervention baseline burden levels (Week 1) at post-intervention (Week 10).
    Change in Levels of Self-Compassion
    Change score on Self-Compassion Scale: Change from pre-intervention baseline level of self-compassion (Week 1) at post-intervention (Week 10).
    Change in Cognitive Functioning
    Change score on Montreal Cognitive Assessment (MoCA): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).
    Change in Cognitive Functioning
    Change score on Modified Mini-Mental State Exam (3MS): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).
    Change in Working Memory
    Change score on Digit Span Forward and Backward: Change from pre-intervention baseline working memory (Week 1) at post-intervention (Week 10).
    Change in Cognitive Flexibility
    Change score on Trail Making A and B Tasks: Change from pre-intervention baseline cognitive flexibility (Week 1) at post-intervention (Week 10).
    Change in Verbal Fluency
    Change score on Category Fluency Test: Change from pre-intervention baseline verbal fluency (Week 1) at post-intervention (Week 10).
    Change in Short-Term Verbal Memory
    Change score on trial one of California Verbal Learning Test: Change from pre-intervention baseline verbal memory (Week 1) at post-intervention (Week 10).
    Change in Attention
    Change score on Attention Network Task: Change from pre-intervention baseline attention (Week 1) at post-intervention (Week 10).
    Change in Depression Symptoms
    Change score on Depression, Anxiety, and Stress Scale: Change from pre-intervention baseline depression symptoms (Week 1) at post-intervention (Week 10).
    Change in Levels of Mindfulness
    Change score on 5 Facet Questionnaire: Change from pre-intervention baseline mindfulness levels (Week 1) at post-intervention (Week 10).

    Full Information

    First Posted
    January 14, 2013
    Last Updated
    April 2, 2015
    Sponsor
    Lakehead University
    Collaborators
    Alzheimer Society of Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01774448
    Brief Title
    Mindfulness Research Program: Designed to Enhance Wellbeing in People Living With Dementia and Their Spouses
    Acronym
    MBCT_AD
    Official Title
    The Efficacy of Mindfulness-Based Cognitive Therapy (MBCT) to Improve Depression Symptoms and Quality of Life in Individuals With Dementia and Their Caregivers: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lakehead University
    Collaborators
    Alzheimer Society of Canada

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    People with dementia forget things and have trouble concentrating. In addition, they and their caregivers can become depressed. This project will show whether Mindfulness-Based Cognitive Therapy (MBCT) can lessen depression, increase attention spans and improve quality of life for those affected by the disease and their caregivers. MBCT combines intensive training in mindfulness meditation with Cognitive Behavioural Therapy. Studies show the meditation component creates changes in areas of the brain associated with our ability to pay attention. This form of meditation can help those impacted by dementia become more aware of their depressive thinking, leading to improved ways of coping. The investigators predict that individuals in the early stages of dementia and their spousal caregivers will report fewer depression symptoms following the 8-week Mindfulness-Based Cognitive Therapy (MBCT) Program, as well as experience improvements in quality of life and daily mindfulness. If successful, MBCT could improve the quality of life in individuals with dementia and their caregivers, as well as may take pressure off the health care system by delaying institutionalization.
    Detailed Description
    The overall objective of the proposed study is to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) to alleviate depression symptoms, increase attention abilities, and improve quality of life in individuals with dementia and their caregivers. MBCT works to help individuals increase concentration and increase awareness of depressive thinking to ultimately provide a better means of coping and emotional regulation. While dementia is non-reversible and progressive in nature, supportive interventions, especially at the early stage of the disease, can make life more manageable for both dementia individuals and their caregivers. Along with the initial signs of forgetfulness and concentration difficulties, it is common for both individuals with dementia and their primary caregivers to also experience depression symptoms. For dementia individuals, depression symptoms are common early on as they still have insight into their disease. This increase in depression has been shown to be related to apathy, overall poorer quality of life and cognitive decline. Caregivers not only witness a significant change in daily functioning of someone they love and know well, they are also faced with new responsibilities associated with managing the disease, while simultaneously trying to juggling their own day-to-day tasks. These drastic changes and increased responsibilities have been shown to increase feelings of depression and burden, resulting in coping-related problems in caregivers. Counseling intervention in early stages of dementia has been shown to delay and even decrease patient admittance into long-term facilities, ultimately relieving stress placed on the healthcare system. MBCT is a specific program designed to, and proven successful at, treating various populations with recurrent depression. With its unique therapeutic approach of integrating intensive training in mindfulness meditation with Cognitive Behavioural Therapy, MBCT helps individuals pay greater attention, increase concentration, increase awareness of depressive thinking and learn to apply more skillful means of coping. In addition to treating depression, the meditation component of MBCT has also been shown to improve various aspects of attention and result in changes in neural networks implicated in attention processes. The investigators predict that MBCT will alleviate depression symptoms and increase quality of life in both patients and caregivers. The investigators also expect that individuals will experience improvements in attention and memory abilities. If successful, MBCT could improve overall quality of life in dementia individuals and caregivers, as well as benefit our healthcare system by delaying institutionalization. From a research perspective, success of this program may lead to a larger clinical controlled trial to further investigate the efficacy of MBCT in individuals affected by dementia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Dementia, Spouse Caregiver, Depression, Mind Body Therapy, Cognitive Therapy, Quality of Life, Attention, Memory

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Waitlist Control
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will undergo a non-intervention 8-week period while on the 'waitlist control' then will be crossed-over to the Mindfulness-Based Cognitive Therapy intervention.
    Arm Title
    Mindfulness-Based Cognitive Therapy
    Arm Type
    Experimental
    Arm Description
    Mindfulness-Based Cognitive Therapy is an 8-week intervention, one session per week for 2 hours, where participants will learn and practice formal and informal mindfulness meditation, and participate in group discussion and inquiry.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-Based Cognitive Therapy
    Intervention Description
    In the experimental condition, individuals with dementia (n = 15) and their spouses (n = 15) will partake in one MBCT session per week for 8 weeks. The partners will attend separate MBCT sessions (different day of the week). In the control condition, individuals with dementia (n = 15) and their spouses (n= 15) will go through an 8-week waitlist control period.
    Primary Outcome Measure Information:
    Title
    Change in Depression Symptoms
    Description
    Change score on Geriatric Depression Scale: Change from pre-intervention baseline depression symptoms (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Apathy Levels
    Description
    Change score on Apathy Evaluation Scale: Change from pre-intervention baseline apathy levels (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Quality of Life
    Description
    Change score on Quality of Life-AD Scale: Change from pre-intervention baseline quality of life (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Anxiety Levels
    Description
    Change score on Depression, Anxiety and Stress Scale: Change from pre-intervention baseline anxiety symptoms (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Levels of Coping
    Description
    Change score on the Brief COPE: Change from pre-intervention baseline levels of coping (Week 1) at post-intervention (Week 10).
    Time Frame
    10 Weeks
    Title
    Change in Burden Levels
    Description
    Change score on Zarit Burden Inventory: Change from pre-intervention baseline burden levels (Week 1) at post-intervention (Week 10).
    Time Frame
    10 Weeks
    Title
    Change in Levels of Self-Compassion
    Description
    Change score on Self-Compassion Scale: Change from pre-intervention baseline level of self-compassion (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Cognitive Functioning
    Description
    Change score on Montreal Cognitive Assessment (MoCA): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).
    Time Frame
    10 Weeks
    Title
    Change in Cognitive Functioning
    Description
    Change score on Modified Mini-Mental State Exam (3MS): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Working Memory
    Description
    Change score on Digit Span Forward and Backward: Change from pre-intervention baseline working memory (Week 1) at post-intervention (Week 10).
    Time Frame
    10 Weeks
    Title
    Change in Cognitive Flexibility
    Description
    Change score on Trail Making A and B Tasks: Change from pre-intervention baseline cognitive flexibility (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Verbal Fluency
    Description
    Change score on Category Fluency Test: Change from pre-intervention baseline verbal fluency (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Short-Term Verbal Memory
    Description
    Change score on trial one of California Verbal Learning Test: Change from pre-intervention baseline verbal memory (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Attention
    Description
    Change score on Attention Network Task: Change from pre-intervention baseline attention (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Depression Symptoms
    Description
    Change score on Depression, Anxiety, and Stress Scale: Change from pre-intervention baseline depression symptoms (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks
    Title
    Change in Levels of Mindfulness
    Description
    Change score on 5 Facet Questionnaire: Change from pre-intervention baseline mindfulness levels (Week 1) at post-intervention (Week 10).
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Early stages of dementia Spousal caregiver (no signs of dementia/mild cognitive impairment) Evidence of at least mild depression (in at least one partner) Speak, read, and write in English Exclusion Criteria: Neurological Disorder (other than dementia for dementia group) Psychological Disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lana J Ozen, PhD
    Organizational Affiliation
    Lakehead University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Michel Bedard, PhD
    Organizational Affiliation
    Lakehead University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Mindfulness Research Program: Designed to Enhance Wellbeing in People Living With Dementia and Their Spouses

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