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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02844478
Enrollment
37
Registered
2016-07-26
Start date
2016-09-30
Completion date
2018-06-30
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Physiological, Stress, Psychological, Telomere Shortening

Keywords

Caregiving, Family caregiving, Stress, dementia caregiving, Hispanics, Spanish, Telomere

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)

Interventions

BEHAVIORALSBP English

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.

BEHAVIORALSBP SPANISH

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.

Sponsors

WellMed Charitable Foundation
CollaboratorUNKNOWN
The Claude D. Pepper Older Americans Independence Centers
CollaboratorOTHER
The Sam and Ann Barshop Institute for Longevity and Aging Studies
CollaboratorUNKNOWN
San Antonio Geriatrics Research Education and Clinical Center- GRECC
CollaboratorUNKNOWN
Caring Companions
CollaboratorUNKNOWN
Alzheimer's Association
CollaboratorOTHER
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Telomere lengthBaseline and end of intervention (Week 9)

Secondary

MeasureTime frame
Saliva potential hydrogen (pH)Baseline and end of intervention (Week 9)
Salivary proteinBaseline and end of intervention (Week 9)
Perceived Stress ScaleBaseline and end of intervention (Week 9)
Center for Epidemiologic Depression (CES-D)Baseline and end of intervention (Week 9)
Salivary flow rateBaseline 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)
Screen for Caregiver BurdenBaseline and end of intervention (Week 9)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026