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

October 15, 2018 updated by: The University of Texas Health Science Center at San Antonio

Effect of Stress-Busting Program on Caregivers' Quality of Life, Stress/Immunity Bio-markers, 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78207
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SBP ENGLISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in English
Behavioral: SBP 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.
Other Names:
  • SBP-E
Experimental: SBP SPANISH
Caregivers will complete the 9 -week Stress-Busting Program for Family Caregivers in Spanish
Behavioral: SBP 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.
Other Names:
  • SBP-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telomere length
Time Frame: Baseline and end of intervention (Week 9)
Baseline and end of intervention (Week 9)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

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

Investigators

  • Principal Investigator: Lyda C Arevalo-Flechas, PhD, RN, Audie L. Murphy Va Hospital, Stvhcs
  • Principal Investigator: Chih-Ko Yeh, BDS, PhD, Audie L. Murphy Va Hospital, Stvhcs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 15, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20160309H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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