Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging

Not Applicable

Completed

• Conditions: Stress, Physiological; Telomere Shortening; Stress, Psychological
• Interventions: Behavioral: SBP English; Behavioral: SBP SPANISH

• Registration Number: NCT02844478
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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)

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Study Start: 2016-09
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. 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),

2. over the age of 18,

3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBP ENGLISH	SBP English	Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
SBP SPANISH	SBP SPANISH	Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish

Primary Outcome Measures

Name	Time	Method
Telomere length	Baseline and end of intervention (Week 9)

Secondary Outcome Measures

Name	Time	Method
Salivary protein	Baseline and end of intervention (Week 9)
Center for Epidemiologic Depression (CES-D)	Baseline and end of intervention (Week 9)
C Reactive Protein (CRP)	Baseline and end of intervention (Week 9)
Salivary flow rate	Baseline and end of intervention (Week 9)
Saliva potential hydrogen (pH)	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)

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States