Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

NCT ID: NCT00178568

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Study Completion Date

2009-11-30

Brief Summary

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People under stress, such as those caring for an ill family member, often have trouble with their sleep. The aim of this study is to see if reducing stress and changing a caregiver's sleep and wake patterns will improve his/her sleep. The investigators also will see whether improvements in sleep result in improved mood, health, and general functioning.

Detailed Description

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The general aim of this study is to characterize stress-related sleep disturbances in spousal caregivers of patients with progressive dementia and to test the efficacy of an intervention designed to reduce stress and sleep disturbances. We will compare the efficacy of a Stress Management Plus Health Sleep Practices (SM+HSP) intervention to an attention-only control condition in spousal caregivers of patients with progressive dementia.

Specific Aims for this study are:

Aim 1: To characterize stress-related sleep disruptions in spousal caregivers of patients with progressive dementia.

Aim 2: To test the short-term efficacy of a Stress Management Plus Healthy Sleep Practices (SM+HSP) intervention versus an attention-only control for improving sleep and health outcomes in caregivers of patients with progressive dementia.

Aim 3: To test the durability of the SM+HSP intervention among spousal caregivers of patients with progressive dementia.

Aim 4: To characterize:

1. the impact of stress-related sleep disruptions on health in older adults, and
2. the effects of sleep interventions on health and functioning.

Conditions

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Sleep Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Stress Management and Healthy Sleep Practices

Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Ages 60 or older
* Spousal caregivers of patients with progressive dementia
* Patients have a diagnosis of possible or probable Alzheimer's disease or other progressive dementia
* Affirm that it is a physical and emotional strain to care for spouse
* Pittsburgh Sleep Quality Index score of 5 or above or a polysomnographically determined sleep efficiency of 90% or worse.

Exclusion Criteria

* Psychotic disorder or substance abuse disorder
* Apnea-hypopnea index of greater than 30
* Score of less than 24 on Mini-Mental State Exam
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Kathy Kennedy

OTHER

Sponsor Role lead

Responsible Party

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Kathy Kennedy

Research Program Administrator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martica Hall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Lynn Martire, Ph.D.

Role: STUDY_DIRECTOR

University of Pittsburgh Medical Center

Greg Seigel, Ph.D.

Role: STUDY_DIRECTOR

University of Pittsburgh Medical Center

Richard Schulz, Ph.D.

Role: STUDY_DIRECTOR

University of Pittsburgh Medical Center

Charles F. Reynolds, III, M.D.

Role: STUDY_DIRECTOR

University of Pittsburgh Medical Center

Locations

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University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

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Related Links

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http://www.aging.upmc.com

University of Pittsburgh Institute on Aging

Other Identifiers

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1P01AG020677-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

021117

Identifier Type: -

Identifier Source: org_study_id

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