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Completed

NCT Number: NCT01774448

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy

Behavioral

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 outcomes

  1. Change in Depression Symptoms

    Time frame: 10 weeks

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

Secondary outcomes

  1. Change in Apathy Levels

    Time frame: 10 weeks

    Change score on Apathy Evaluation Scale: Change from pre-intervention baseline apathy levels (Week 1) at post-intervention (Week 10).

  2. Change in Quality of Life

    Time frame: 10 weeks

    Change score on Quality of Life-AD Scale: Change from pre-intervention baseline quality of life (Week 1) at post-intervention (Week 10).

  3. Change in Anxiety Levels

    Time frame: 10 weeks

    Change score on Depression, Anxiety and Stress Scale: Change from pre-intervention baseline anxiety symptoms (Week 1) at post-intervention (Week 10).

  4. Change in Levels of Coping

    Time frame: 10 Weeks

    Change score on the Brief COPE: Change from pre-intervention baseline levels of coping (Week 1) at post-intervention (Week 10).

  5. Change in Burden Levels

    Time frame: 10 Weeks

    Change score on Zarit Burden Inventory: Change from pre-intervention baseline burden levels (Week 1) at post-intervention (Week 10).

  6. Change in Levels of Self-Compassion

    Time frame: 10 weeks

    Change score on Self-Compassion Scale: Change from pre-intervention baseline level of self-compassion (Week 1) at post-intervention (Week 10).

  7. Change in Cognitive Functioning

    Time frame: 10 Weeks

    Change score on Montreal Cognitive Assessment (MoCA): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).

  8. Change in Cognitive Functioning

    Time frame: 10 weeks

    Change score on Modified Mini-Mental State Exam (3MS): Change from pre-intervention baseline cognitive functioning (Week 1) at post-intervention (Week 10).

  9. Change in Working Memory

    Time frame: 10 Weeks

    Change score on Digit Span Forward and Backward: Change from pre-intervention baseline working memory (Week 1) at post-intervention (Week 10).

  10. Change in Cognitive Flexibility

    Time frame: 10 weeks

    Change score on Trail Making A and B Tasks: Change from pre-intervention baseline cognitive flexibility (Week 1) at post-intervention (Week 10).

  11. Change in Verbal Fluency

    Time frame: 10 weeks

    Change score on Category Fluency Test: Change from pre-intervention baseline verbal fluency (Week 1) at post-intervention (Week 10).

  12. Change in Short-Term Verbal Memory

    Time frame: 10 weeks

    Change score on trial one of California Verbal Learning Test: Change from pre-intervention baseline verbal memory (Week 1) at post-intervention (Week 10).

  13. Change in Attention

    Time frame: 10 weeks

    Change score on Attention Network Task: Change from pre-intervention baseline attention (Week 1) at post-intervention (Week 10).

  14. Change in Depression Symptoms

    Time frame: 10 weeks

    Change score on Depression, Anxiety, and Stress Scale: Change from pre-intervention baseline depression symptoms (Week 1) at post-intervention (Week 10).

  15. Change in Levels of Mindfulness

    Time frame: 10 weeks

    Change score on 5 Facet Questionnaire: Change from pre-intervention baseline mindfulness levels (Week 1) at post-intervention (Week 10).

Sponsors and collaborators

Lead sponsor

Lakehead University

Other

Collaborators

  • Alzheimer Society of Canada

Registry information

Official study 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

Acronym: MBCT_AD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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