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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Stress, Psychological, Telomere Shortening, Stress, Physiological

Intervention / Treatment
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* Behavioral: SBP English
* Behavioral: SBP SPANISH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SBP ENGLISH<br>Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English | Behavioral: SBP English<br>* The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks.<br>* Other names: SBP-E;|
| Experimental: SBP SPANISH<br>Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish | Behavioral: SBP SPANISH<br>* The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks. The Spanish translation and cultural adaptation of the SBP has been completed under the direction of the PI.<br>* Other names: SBP-S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomere length |  | Baseline and end of intervention (Week 9) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary flow rate |  | 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) | 
| Perceived Stress Scale |  | Baseline and end of intervention (Week 9) | 
| Center for Epidemiologic Depression (CES-D) |  | 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) | 
| C Reactive Protein (CRP) |  | Baseline and end of intervention (Week 9) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere