Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia - Tabular View

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Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

This study is ongoing, but not recruiting participants.
Information provided by University of Pittsburgh

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

Official Title ^†

AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia

Brief Summary

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

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:

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

Study Phase

Phase I

Study Type ^†

Observational

Study Design ^†

Case Control, Cross-Sectional

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Sleep Disorders

Intervention ^†

Behavioral: Stress Management and Healthy Sleep Practices

MEDLINE PMIDs

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Links

University of Pittsburgh Institute on Aging This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

February 2003

Completion Date

November 2008

Eligibility Criteria ^†

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00178568

Organization ID

021117

Secondary IDs ^††

1 P01 AG20677-01

Study Sponsor ^†

University of Pittsburgh

Collaborators ^††

National Institute on Aging (NIA)

Investigators ^†

Principal Investigator:	Martica Hall, Ph.D.	University of Pittsburgh
Study Director:	Lynn Martire, Ph.D.	University of Pittsburgh
Study Director:	Greg Seigel, Ph.D.	University of Pittsburgh
Study Director:	Richard Schulz, Ph.D.	University of Pittsburgh
Study Director:	Charles F. Reynolds, III, M.D.	University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

June 2008

First Received Date ^†

September 13, 2005

Last Updated Date

June 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.