ACT for Individuals With MNCD and Their Care Partners
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance Commitment Therapy.
- Who it may be relevant to
- Registry conditions: Depression in Adults, Anxiety Disorder Generalized, Grief. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acceptance and Commitment Therapy for Individuals With MNCD and Their Care Partners: An In-Person and Telehealth Individual Therapy Approach
Overview
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.
Detailed description
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:
1. Evaluate the feasibility and acceptability of this shortened ACT program for persons with MCI or MNCD. 2. Assess the preliminary efficacy of this ACT program for persons with MCI or MNCD. 3. Evaluate if this intervention program has positive downstream effects on the care partners.
Interventions
- Behavioral Acceptance Commitment Therapy
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.
Primary outcome measures
- Patient Health Questionnaire-9 [Time frame: 6 weeks]
- Geriatric Depression Short From [Time frame: 6 Weeks]
- The Generalized Anxiety Disorder-7 [Time frame: 6 weeks]
- General Anxiety Scale-10 [Time frame: 6 Weeks]
- Pre-death grief-12 [Time frame: 6 weeks]
Secondary outcome measures (8)
- Dyadic Coping Inventory [Time frame: 6 Weeks]
- Short Form Health Survey (SF-12) [Time frame: 6 Weeks]
- Purpose in Life Scale [Time frame: 6 Weeks]
- Herth Hope Index [Time frame: 6 Weeks]
- Inclusion of Other in the Self Scale [Time frame: 6 Weeks]
- Perceived Stress Scale [Time frame: 6 Weeks]
- Pittsburgh Sleep Quality Index [Time frame: 6 Weeks]
- Repeatable Battery for the Assessment of Neuropsychological Status [Time frame: 6 Weeks]
Eligibility criteria
Inclusion criteria
Inclusion (person with MCI or MNCD):
- 18+
- MMSE= 21-27
- Able to communicate in English
Inclusion (care partner):
- 18+
- Identifies as a care partner of a person with MNCD
- Able to communicate in English
- MMSE= 28-30
- Is a family member or friend of the person with MNCD
Exclusion criteria
Exclusion (person with MCI or MNCD):
- Currently in an intervention for reducing anxiety or depression related to their dementia
- MMSE= 28+ or less than 21
Exclusion (care partner):
- MMSE= <28
- Is a formal (paid) caregiver
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Texas Tech University Plaza Building — Lubbock
Identifiers
NCT: NCT07239609 · TexasTechU7