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Clinical Trials/NCT02844478
NCT02844478
Completed
Not Applicable

Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, and Cellular Aging

The University of Texas Health Science Center at San Antonio1 site in 1 country37 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
37
Locations
1
Primary Endpoint
Telomere length
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to explore the differences in quality of life , inflammation, stress, telomere length, and mucosal immune function of Hispanic and non-Hispanic caregivers of persons with Alzheimer's disease and related dementias (ADRD). The caregivers will complete the Stress-Busting Program for Family Caregivers in the language of their choice (English or Spanish).

Detailed Description

The overarching goal of this project is to (1) explore the differences in quality of life (QoL), inflammation, stress, telomere length, and mucosal immune function of Hispanic caregivers of persons with ADRD and (2) determine whether a caregiver intervention can effectively improve the QoL, inflammation, stress, telomere length, and mucosal immune function biomarkers of Hispanic caregivers. The proposed study is a non-randomized trial design with three groups of ADRD caregivers that vary based on Hispanic ethnicity and English/Spanish language preference. The project's specific aims are: Specific Aim 1: To compare the quality of life (QoL) (stress, depression, and burden), mucosal immunity function (sIgA), stress (sCortisol and sAmylase), inflammation(CRP), and telomere length in Spanish-speaking Hispanic, English-speaking Hispanic, and English-speaking non-Hispanic caregivers who participate in an evidence-based Stress-Busting Program (SBP) for family caregivers of family members living with ADRD. Working hypothesis: At baseline, Spanish-speaking Hispanic caregivers have lower QoL and immune function, higher levels of inflammation and stress, and shorter telomeres as compared to Hispanic and non-Hispanic English-speaking caregivers. Specific Aim 2: To compare the impact of the SBP on QoL and biomarkers for stress, aging, inflammation and mucosal immunity among those caregivers completing the SBP (Hispanic caregivers completing the culturally adapted translated version to Spanish of SBP and Hispanic and non-Hispanic caregivers completing the English-SBP). Working Hypothesis: Spanish-speaking Hispanic caregivers completing the Spanish-SBP show more improvement in their QoL and biomarkers of stress, mucosal immunity, aging and inflammation post-intervention as compared to Hispanic and Non-Hispanic caregivers completing the English-SBP. To achieve these aims, the investigators propose to deliver the 9-week English SBP and the translated and culturally adapted Spanish-SBP. Saliva and blood samples and self- report measures of QoL will be collected at baseline and 9 weeks (end of intervention)

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
June 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • self-identified caregiver for a person living with ADRD. Family caregivers of people with ADRD include spouses, adult children, grandchildren, siblings, partners, and significant others.
  • In addition to Alzheimer's disease, other causes of dementia include multiple sclerosis, Parkinson's, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI),
  • over the age of 18,
  • those wishing to participate in the Spanish SBP must speak and read Spanish.

Exclusion Criteria

  • Speaking a language other than English or Spanish
  • Caring for an individual not diagnosed with a cognitive impairment as delineated in inclusion criteria.

Outcomes

Primary Outcomes

Telomere length

Time Frame: Baseline and end of intervention (Week 9)

Secondary Outcomes

  • C Reactive Protein (CRP)(Baseline and end of intervention (Week 9))
  • Saliva potential hydrogen (pH)(Baseline and end of intervention (Week 9))
  • Salivary protein(Baseline and end of intervention (Week 9))
  • Center for Epidemiologic Depression (CES-D)(Baseline and end of intervention (Week 9))
  • Salivary flow rate(Baseline and end of intervention (Week 9))
  • Perceived Stress Scale(Baseline and end of intervention (Week 9))
  • Screen for Caregiver Burden(Baseline and end of intervention (Week 9))
  • Salivary alpha Amylase (sAA)(Baseline and end of intervention (Week 9))
  • Secretory immunoglobulin A (SIgA)(Baseline and end of intervention (Week 9))

Study Sites (1)

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