Meditation or Education for Alzheimer Caregivers

NCT00558402 | Completed Phase 2 DMC

• 1 other identifier: IRB00002226
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to determine how 6-week stress reduction techniques may decrease stress in primary caregivers of people with Alzheimer's disease. The 3 intervention programs are meditation, education, and respite care. There will be approximately 108 subjects over 3 years. Subjects will have a screening session over the phone to see if they are eligible (50-85 years old, spending at least 12 hours per week caring for a close relative with Alzheimer's disease, willing to be in any of the 3 groups, and without any very serious medical problem). The subjects will have 3 testing sessions, 1 before classes/respite and 2 after classes are over, each lasting about 3 hours. The classes are taught in a one-on-one setting, and they are 50 minutes per week for 6 weeks. Respite care is provided for the person with Alzheimer's disease in all the groups. Measurements include people's ratings of stress, psychological testing, and biological measurements of stress, including the following: saliva, blood, and urine collection; waist-to-hip ratio; weight; blood pressure; heart rate; respiration; reaction time task; voice recordings; electrocardiogram; electroencephalogram; and electro dermal activity.

Conditions

Caregivers; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Caregiver stress (Revised Memory and Behavior Problems Checklist)

  8 and 20 weeks

Secondary Outcomes (3)

• 5-Facet Mindfulness Questionnaire

  0, 8 and 20 weeks

• Perceived Self-Efficacy

  Measured 0, 8, and 16 Weeks

• EEG measuring reaction time

  Measured at 0, 8, and 16 weeks

Study Arms (3)

1

EXPERIMENTAL

Meditation class, 90min/week for 8 weeks, with home assignments, adapted from MBCT program

Behavioral: Meditation

2

ACTIVE COMPARATOR

Education

Behavioral: Education

3

ACTIVE COMPARATOR

Respite care only, 90 mins per week for 8 weeks

Behavioral: Respite only

Interventions

Meditation BEHAVIORAL

meditation class 1/week for 8 weeks

Also known as: Mindfulness Based Stress Reduction

1

Education BEHAVIORAL

Education class, 90 min per week for 8 weeks along with home assignments based on Powerful Tools for Caregivers

Also known as: Powerful Tools for Caregivers

2

Respite only BEHAVIORAL

Respite care 90 mins per week for 8 weeks

Also known as: Respite care

3

Eligibility Criteria

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

You may qualify if:

• year olds who are the primary caregiver of someone with Alzheimer disease (family member or other close relationship)

You may not qualify if:

• cognitively impaired
• unstable medical problems
• untreated significant depression
• taking CNS-active medications that have not been stable for 2 months
• significant visual impairment (acuity worse than 20/50 OU)
• experience with meditation classes of with Powerful Tools for Caregivers classes
• not have significant baseline stress
• evidence on history of certain significant neurological diseases
• unwilling to accept randomization or to commit to attending classes and practicing the interventions

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Meditation; Mindfulness-Based Stress Reduction; Educational Status; Caregivers; Respite Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness; Cognitive Behavioral Therapy; Socioeconomic Factors; Population Characteristics; Health Personnel; Health Care Facilities Workforce and Services; Home Nursing; Nursing Care; Patient Care; Home Care Services; Community Health Services; Health Services

Study Officials

• Barry S Oken, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

US (1)