Clinical trial NCT00178568: Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia
Official title: AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: Caregiving
Spousal
Sleep disturbances
Progressive dementia
Stress
Health outcomes
Intervention
Affective self-management
Caregivers M01.526.485.200
Spouses F01.829.263.500.660
Alzheimer's disease C10.574.945.249
Parkinson's disease C10.574.812
Sleep disorder C10.886.425.800.800
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females over the age of 60 who are primary caregiver for spouse/partner diagnosed with progressive dementia.

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.

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

Primary outcomes:
measure: Polysomnography pre and post intervention
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Martica Hall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Lynn Martire, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh Medical Center
name: Greg Seigel, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh Medical Center
name: Richard Schulz, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh Medical Center
name: Charles F. Reynolds, III, M.D.
role: STUDY_DIRECTOR
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