Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

Sponsor
Kathy Kennedy (Other)
Overall Status
Completed
CT.gov ID
NCT00178568
Collaborator
National Institute on Aging (NIA) (NIH)
60
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81
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stress Management and Healthy Sleep Practices

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia
Study Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Polysomnography pre and post intervention [18 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • Kathy Kennedy
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Kathy Kennedy, Research Program Administrator, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178568
Other Study ID Numbers:
  • 021117
  • 1P01AG020677-01
First Posted:
Sep 15, 2005
Last Update Posted:
May 28, 2015
Last Verified:
May 1, 2015

Study Results

No Results Posted as of May 28, 2015