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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

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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:

  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 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
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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  60
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.




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