PST for Care Partners of Adults With Alzheimer's and Alzheimer'S-related Dementia

NCT04748666 | Completed

• 1 other identifier: STU-2020-1276
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief Summary

Caregivers of individuals with Alzheimer's disease and related dementia rarely get the preparation or training they need to manage their caregiving responsibilities and to successfully balance their own self-care and their caregiving roles. As a result, caregivers often experience caregiver burden, emotional distress, and substance abuse. Therefore, there is a critical need to support the emotional and social functioning of caregivers to improve their health and well-being and to prevent caregiver burden and poor coping. Problem solving training (PST) is an evidence-based approach that teaches and empowers individuals to solve emergent problems contributing to their depressive symptoms, helps improve coping skills and increases self-efficacy. However, critical gaps in knowledge and care remain regarding the necessary components of training (eg. How many sessions? What is the influence of personal factors?) that affect how effective PST is for individual caregivers. Finally, caregiver interventions have almost exclusively been tested in English-speaking caregivers, further contributing to existing health disparities among minority groups. To address this critical need, Dr. Shannon Juengst, Assistant Professor of Physical Medicine and Rehabilitation was awarded a new Texas Alzheimer's Research and Care Consortium Collaborative Research Grant entitled, "Problem Solving Training (PST) for English- and Spanish-speaking Care Partners of Adults with Alzheimer's and Alzheimer's Related Dementia." For this project, Dr. Juengst has assembled a strong, multidisciplinary team with Dr. Gladys Maestre, Professor of Biomedical Sciences and Director of the NIA funded-Alzheimer's Disease Resource Center for Minority and Aging Research and Memory Disorders Center at UT Rio Grande Valley and Dr. Matthew Smith, Associate Professor of Environmental and Occupational Health and Co-Director of the Center for Population Health and Aging at Texas A\&M University. This project will establish the necessary guidelines for an evidence-based, implementable problem-solving intervention for both English- and Spanish-speaking caregivers to improve their health and well-being and identify potential mechanisms of action for such training.

Conditions

Alzheimer Disease; Frontotemporal Degeneration (FTD); Lewy Body Dementia (LBD); Vascular Contributions to Cognitive Impairment and Dementia (VCID); Mixed Etiology Dementias (MED); Mild Cognitive Impairment (MCI)

Keywords

Alzheimer Disease; Frontotemporal Degeneration; Lewy Body Dementia; Vascular contributions to cognitive impairment and dementia; Mixed etiology dementias; Mild Cognitive Impairment; Care partner; Caregiver; Alzheimer's-related Dementia

Outcome Measures

Primary Outcomes (2)

• The Mean Change in Patient Health Questionnaire (PHQ-8) Score

  Patient Health Questionnaire (PHQ-9) assesses DSIM-IV-TR symptoms that define major depressive episode. Scores range from 0-27 for severity. The PHQ8 omits the final question about suicidality, resulting in a validated scale with scores ranging from 0-24.: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and \>20 (severe).

  Baseline, 6 months

• The Mean Change in Zarit Burden Interview Score

  Zarit Burden Interview (ZBI) is a 22-item self-reported measure of perceived caregiver burden, including items related to psychological and emotional health, well-being, social and family life, finances, and perceive control. Cutoff scores are mild: 2-20; mild to moderate: 21-40; moderate to severe:41-60; severe: 61-88 burden

  Baseline, 6 months

Secondary Outcomes (3)

• The Mean Change in Family Caregivers Scale/Caregiver experience Score

  Baseline, 6 months

• The Mean Change in Client Satisfaction Questionnaire (CSQ-8) Score

  6 months

• Upstream Social Isolation Risk Screener (U-SIRS13)

  Baseline, 6 months

Study Arms (4)

3 PST sessions and no boosters

EXPERIMENTAL

Behavioral: Problem Solving Training

3 PST sessions with monthly boosters for 6 months

EXPERIMENTAL

Behavioral: Problem Solving Training

6 PST sessions, no boosters

EXPERIMENTAL

Behavioral: Problem Solving Training

6 PST sessions with monthly boosters for 6 months

EXPERIMENTAL

Behavioral: Problem Solving Training

Interventions

Problem Solving Training BEHAVIORAL

Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, that teaches a simple, systematic method for evaluating problems, generating and selecting solutions, developing specific goals and action plans, and evaluating and revising plans as needed.

3 PST sessions and no boosters; 3 PST sessions with monthly boosters for 6 months; 6 PST sessions with monthly boosters for 6 months; 6 PST sessions, no boosters

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female, Male, Transgender/other
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PHQ2 Score of 2 or higher and/or ZBI4 Score of 2 or higher
• years or older
• Able to speak fluently in English or Spanish
• Cognitively able to make decisions, as determined by ability to provide informed consent
• Care partner/caregiver to individual with AD/ADRD
• Individual must have at least one year or more of a relationship with patient with AD/ADRD

You may not qualify if:

• Dispute over care partner's role in the care of patient
• Has previously participated in other PST study at UTSW within the past year

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of Texas Rio Grande Valley: collaborator
• Texas A&M University: collaborator

Study Sites (3)

Texas A&M University

College Station, Texas, 77840, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Texas Rio Grande Valley

Edinburg, Texas, 78539, United States

Location

Related Publications (31)

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  BACKGROUND

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• Juengst SB, Osborne CL, Holavanahalli R, Silva V, Kew CL, Nabasny A, Bell KR. Feasibility Study of Problem-Solving Training for Care Partners of Adults With Traumatic Brain Injury, Spinal Cord Injury, Burn Injury, or Stroke During the Inpatient Hospital Stay. Arch Rehabil Res Clin Transl. 2019 Jun 27;1(3-4):100009. doi: 10.1016/j.arrct.2019.100009. eCollection 2019 Dec.

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  PMID: 41142740 DERIVED

Related Links

• Caregiving in the U.S. 2009 Full Report
• U.S. Census Bureau QuickFacts

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Dementia; Mixed Dementias; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders

Study Officials

• Shannon Juengst, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The investigators will compare a) care partner emotional symptom (depression) change and b) caregiver burden change from baseline to 6-months post-baseline, to assessed long-term effects of PST and booster sessions several months beyond completion of the training. The investigators will also measure secondary care partner outcomes, including caregiver self-efficacy, positive aspects of caregiving, and alcohol use. Finally, the investigators will assess care partners' satisfaction, confidence using the PST strategy, and engagement across all conditions.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: June 14, 2021
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)