ACT for Individuals With MNCD and Their Care Partners (ACT)

Acceptance and Commitment Therapy for Individuals With MNCD and Their Care Partners: An In-Person and Telehealth Individual Therapy Approach

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.

Study Overview

• Status: Recruiting
• Conditions: Grief; Anxiety Disorder Generalized; Depression in Adults
• Intervention / Treatment: Behavioral: Acceptance Commitment Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jonathan Singer, Ph.D.; Phone Number: 17757228066; Email: jonsinge@ttu.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409-2051
      • Recruiting
      • Texas Tech University Plaza Building
      • Contact: Jonathan Singer, Ph.D.; Phone Number: 7757228066; Email: jonsinge@ttu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9	PHQ-9 is used to assess the presence and severity of depressive symptoms.	6 weeks
Geriatric Depression Short From	GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.	6 Weeks
The Generalized Anxiety Disorder-7	GAD-7 is used to assess the severity of generalized anxiety symptoms	6 weeks
General Anxiety Scale-10	The GAS-10 is designed to assess the severity of general anxiety symptoms	6 Weeks
Pre-death grief-12	The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyadic Coping Inventory	The DCI assess how couples support each other and cope together with stress.	6 Weeks
Short Form Health Survey (SF-12)	The SF-12 measures functional health and well-being	6 Weeks
Purpose in Life Scale	The PIL is designed to assess an individual's sense of meaning and purpose in life.	6 Weeks
Herth Hope Index	The HHI is designed to measure an individual's level of hope	6 Weeks
Inclusion of Other in the Self Scale	The IOS is designed to assess perceived closeness in interpersonal relationships	6 Weeks
Perceived Stress Scale	The PSS is a measure the degree to which individuals perceive their lives as stressful	6 Weeks
Pittsburgh Sleep Quality Index	The PSQI assess sleep quality and disturbances.	6 Weeks
Repeatable Battery for the Assessment of Neuropsychological Status	The RBANS is a neuropsychological assessment designed to evaluate cognitive functioning	6 Weeks

Collaborators and Investigators

• Sponsor: Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mild Neurocognitive Disorder; Dyadic intervention; Mild Cognitive Impariment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Neurocognitive Disorders; Generalized Anxiety Disorder; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: TexasTechU7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will not be providing any individual participant data. It will all be aggregate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No