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Clinical Trials/NCT00178568
NCT00178568
Completed
Not Applicable

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

Kathy Kennedy1 site in 1 country60 target enrollmentFebruary 2003
ConditionsSleep Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorders
Sponsor
Kathy Kennedy
Enrollment
60
Locations
1
Primary Endpoint
Polysomnography pre and post intervention
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
November 2009
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kathy Kennedy
Responsible Party
Sponsor Investigator
Principal Investigator

Kathy Kennedy

Research Program Administrator

University of Pittsburgh

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

Outcomes

Primary Outcomes

Polysomnography pre and post intervention

Time Frame: 18 months

collection of physiological \& psychological variables pre and post BBTI sleep disturbances and stress in caregivers

Study Sites (1)

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