Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178568
• Other study ID #: 021117
• Secondary ID: 1P01AG020677-01
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: May 26, 2015
• Start date: February 2003
• Est. completion date: November 2009

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dementia
• Dyssomnias
• Parasomnias
• Sleep Disorders

Intervention

Behavioral:
• Stress Management and Healthy Sleep Practices
Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Kathy Kennedy	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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* Note: There are 87 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography pre and post intervention	collection of physiological & psychological variables pre and post BBTI sleep disturbances and stress in caregivers	18 months	No

External Links

•   University of Pittsburgh Institute on Aging