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NCT Number: NCT07239609

ACT for Individuals With MNCD and Their Care Partners

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Texas Tech University Plaza Building

Lubbock, Texas, 79409-2051, United States

Location status: Recruiting

Location contact

Jonathan Singer, Ph.D.

CONTACT

[email protected]

7757228066

About this study

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:

  • Evaluate the feasibility and acceptability of this shortened ACT program for persons with MCI or MNCD.
  • Assess the preliminary efficacy of this ACT program for persons with MCI or MNCD.
  • Evaluate if this intervention program has positive downstream effects on the care partners.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance Commitment Therapy

Behavioral

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 outcomes

  1. Patient Health Questionnaire-9

    Time frame: 6 weeks

    PHQ-9 is used to assess the presence and severity of depressive symptoms.

  2. Geriatric Depression Short From

    Time frame: 6 Weeks

    GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.

  3. The Generalized Anxiety Disorder-7

    Time frame: 6 weeks

    GAD-7 is used to assess the severity of generalized anxiety symptoms

  4. General Anxiety Scale-10

    Time frame: 6 Weeks

    The GAS-10 is designed to assess the severity of general anxiety symptoms

  5. Pre-death grief-12

    Time frame: 6 weeks

    The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.

Secondary outcomes

  1. Dyadic Coping Inventory

    Time frame: 6 Weeks

    The DCI assess how couples support each other and cope together with stress.

  2. Short Form Health Survey (SF-12)

    Time frame: 6 Weeks

    The SF-12 measures functional health and well-being

  3. Purpose in Life Scale

    Time frame: 6 Weeks

    The PIL is designed to assess an individual's sense of meaning and purpose in life.

  4. Herth Hope Index

    Time frame: 6 Weeks

    The HHI is designed to measure an individual's level of hope

  5. Inclusion of Other in the Self Scale

    Time frame: 6 Weeks

    The IOS is designed to assess perceived closeness in interpersonal relationships

  6. Perceived Stress Scale

    Time frame: 6 Weeks

    The PSS is a measure the degree to which individuals perceive their lives as stressful

  7. Pittsburgh Sleep Quality Index

    Time frame: 6 Weeks

    The PSQI assess sleep quality and disturbances.

  8. Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: 6 Weeks

    The RBANS is a neuropsychological assessment designed to evaluate cognitive functioning

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Singer, Ph.D.

CONTACT

[email protected]

17757228066

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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