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

NCT01774448 | Completed

• 1 other identifier: ASC-1309
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Keywords

Dementia; Spouse Caregiver; Depression; Mind Body Therapy; Cognitive Therapy; Quality of Life; Attention; Memory

Outcome Measures

Primary Outcomes (1)

• Change in Depression Symptoms

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

  10 weeks

Secondary Outcomes (15)

• Change in Apathy Levels

  10 weeks

• Change in Quality of Life

  10 weeks

• Change in Anxiety Levels

  10 weeks

• Change in Levels of Coping

  10 Weeks

• Change in Burden Levels

  10 Weeks

Study Arms (2)

Waitlist Control

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

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.

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lakehead University: lead
• Alzheimer Society of Canada: collaborator

MeSH Terms

Conditions

Dementia; Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lana J Ozen, PhD

  Lakehead University

  PRINCIPAL INVESTIGATOR

• Michel Bedard, PhD

  Lakehead University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 24, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04