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Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia
This study is ongoing, but not recruiting participants.
Study NCT00178568   Information provided by University of Pittsburgh
First Received: September 13, 2005   Last Updated: June 9, 2008   History of Changes

September 13, 2005
June 9, 2008
February 2003
November 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00178568 on ClinicalTrials.gov Archive Site
 
 
 
Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia
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.

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.
Phase I
Observational
Case Control, Cross-Sectional
Sleep Disorders
Behavioral: Stress Management and Healthy Sleep Practices
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178568
Dr. Martica Hall, University of Pittsburgh Medical Center - WPIC
021117, 1 P01 AG20677-01
University of Pittsburgh
National Institute on Aging (NIA)
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
University of Pittsburgh
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP