Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

Completed

• Conditions: Sleep Disorders

• Registration Number: NCT00178568
• Lead Sponsor: Kathy Kennedy

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-11
• Study Completion: 2009-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polysomnography pre and post intervention	18 months	collection of physiological \& psychological variables pre and post BBTI sleep disturbances and stress in caregivers

Trial Locations

Locations (1)

University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States