Texas Tech University Plaza Building
Lubbock, Texas, 79409-2051, United States
Location status: Recruiting
NCT Number: NCT07239609
This project aims to implement and evaluate a dyadic intervention (i.e., acceptance commitment therapy) for persons with AD/ADRD and their care partners. We hypothesize the intervention will be feasible, acceptable, and show preliminary efficacy of the dyadic interveniotns.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Lubbock, Texas, 79409-2051, United States
Location status: Recruiting
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (AD/ADRD) are life-limiting, long-term, neurodegenerative conditions estimated to affect more than 6.5 million adults over the age of 65 in the U.S. (Alzheimer's Association, 2023a). A majority of persons with AD/ADRD are over the age of 75 (73%; Alzheimer's Association, 2023a). With an aging population (estimated 1 in 6 people in the world will be over the age of 60 by 2030; World Health Organization, 2022), no known cure, and modern medical advances increasing life expectancy, the prevalence of AD/ADRD continues to rise, an estimated 13.8 million by 2060 (Alzheimer's Association, 2023a). Due to this mostly affecting older adults, 69.1% are living with a comorbid diagnosis (e.g., hypertension; diabetes) (Bennett et al., 2018; Poblador-Plou et al., 2014). AD/ADRD presents a global health crisis, posing profound challenges to not only the individuals with the disease, but has downstream effects on the family unit and the healthcare systems. As number of individuals with AD/ADRD are expected to increase over the next 10 years, it is vital to investigate non-pharmacological interventions for this population in order to improve the negative consequences of this diagnosis. This study aims to bridge this gap by investigating a modified evidence-based intervention, Acceptance Commitment Therapy (ACT), for persons with AD/ADRD and their care partners.
An integral part of an AD/ADRD journey is the care partner, who is usually a spouse or adult child. These care partners provide more than 10 billion hours of care in the United States to individuals with AD/ADRD. This has been found to result in negative outcomes, including high rates of pre-death grief, caregiver burden, and stress. There have been numerous non-pharmacological interventions for these care partners, but few studies have investigated the effects of dyadic interventions for persons with AD/ADRD and their care partners. Dyadic interventions have been found to be effective in improving psychosocial outcomes with persons with other chronic conditions (e.g., cancer) and their care partners (Hu etl a., 2019). The overarching goal of this project is to evaluate if acceptance commitment therapy will have a positive effect on persons recently diagnosed with early stage AD/ADRD.
More specifically, we will:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion (person with MCI or MNCD):
Inclusion (care partner):
Exclusion criteria
Exclusion (person with MCI or MNCD):
Exclusion (care partner):
Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that aims to enhance psychological flexibility through six core processes: acceptance, cognitive defusion, being present, self-as-context, values clarification, and committed action. Rather than attempting to eliminate difficult thoughts and feelings, ACT encourages individuals to accept them while committing to behavior changes consistent with their personal values.
Time frame: 6 weeks
PHQ-9 is used to assess the presence and severity of depressive symptoms.
Time frame: 6 Weeks
GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.
Time frame: 6 weeks
GAD-7 is used to assess the severity of generalized anxiety symptoms
Time frame: 6 Weeks
The GAS-10 is designed to assess the severity of general anxiety symptoms
Time frame: 6 weeks
The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.
Time frame: 6 Weeks
The DCI assess how couples support each other and cope together with stress.
Time frame: 6 Weeks
The SF-12 measures functional health and well-being
Time frame: 6 Weeks
The PIL is designed to assess an individual's sense of meaning and purpose in life.
Time frame: 6 Weeks
The HHI is designed to measure an individual's level of hope
Time frame: 6 Weeks
The IOS is designed to assess perceived closeness in interpersonal relationships
Time frame: 6 Weeks
The PSS is a measure the degree to which individuals perceive their lives as stressful
Time frame: 6 Weeks
The PSQI assess sleep quality and disturbances.
Time frame: 6 Weeks
The RBANS is a neuropsychological assessment designed to evaluate cognitive functioning
Contact information is provided by the study sponsor or research team.
Texas Tech University
Other
Acceptance and Commitment Therapy for Individuals With MNCD and Their Care Partners: An In-Person and Telehealth Individual Therapy Approach
Acronym: ACT
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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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