Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

May 26, 2015 updated by: Kathy Kennedy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

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

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Males and females over the age of 60 who are primary caregiver for spouse/partner diagnosed with progressive dementia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography pre and post intervention
Time Frame: 18 months
collection of physiological & psychological variables pre and post BBTI sleep disturbances and stress in caregivers
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathy Kennedy

Collaborators

National Institute on Aging (NIA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021117
  • 1P01AG020677-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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