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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Lakehead University
Sponsor:
Collaborator:
Alzheimer Society of Canada
Information provided by (Responsible Party):
Michel Bédard, Lakehead University
ClinicalTrials.gov Identifier:
NCT01774448
First received: January 14, 2013
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Dementia
Behavioral: Mindfulness-Based Cognitive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Lakehead University:

Primary Outcome Measures:
  • Change in Depression Symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Change score on Attention Network Task: Change from pre-intervention baseline attention (Week 1) at post-intervention (Week 10).

  • Change in Depression Symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Change score on 5 Facet Questionnaire: Change from pre-intervention baseline mindfulness levels (Week 1) at post-intervention (Week 10).


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Waitlist Control
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.
Experimental: Mindfulness-Based Cognitive Therapy
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.
Behavioral: Mindfulness-Based Cognitive Therapy
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774448

Contacts
Contact: Lana J Ozen, PhD (807) 343-4300 ext 4500 ozenl@tbh.net

Sponsors and Collaborators
Lakehead University
Alzheimer Society of Canada
Investigators
Principal Investigator: Lana J Ozen, PhD Lakehead University
Study Director: Michel Bedard, PhD Lakehead University
  More Information

No publications provided

Responsible Party: Michel Bédard, Full Professor, Lakehead University
ClinicalTrials.gov Identifier: NCT01774448     History of Changes
Other Study ID Numbers: ASC-1309
Study First Received: January 14, 2013
Last Updated: April 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lakehead University:
Dementia
Spouse Caregiver
Depression
Mind Body Therapy
Cognitive Therapy
Quality of Life
Attention
Memory

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014