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OpenTrials
Completed

NCT Number: NCT00178568

Reducing Caregiver Stress and Sleep Disturbances in 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Management and Healthy Sleep Practices

Behavioral

Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.

Primary outcomes

  1. Polysomnography pre and post intervention

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Kathy Kennedy

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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