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Completed

NCT Number: NCT02844478

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBP English

Behavioral

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.

Other names: SBP-E

SBP SPANISH

Behavioral

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.

Other names: SBP-S

Primary outcomes

  1. Telomere length

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

Secondary outcomes

  1. Salivary flow rate

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

  2. Saliva potential hydrogen (pH)

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

  3. Salivary protein

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

  4. Perceived Stress Scale

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

  5. Center for Epidemiologic Depression (CES-D)

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

  6. Screen for Caregiver Burden

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

  7. Salivary alpha Amylase (sAA)

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

  8. Secretory immunoglobulin A (SIgA)

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

  9. C Reactive Protein (CRP)

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Alzheimer's Association
  • Caring Companions
  • San Antonio Geriatrics Research Education and Clinical Center- GRECC
  • The Claude D. Pepper Older Americans Independence Centers
  • The Sam and Ann Barshop Institute for Longevity and Aging Studies
  • WellMed Charitable Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2016
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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