Depression in AdultsPhase 1ACTNCT07239609
ACT for Individuals With MNCD and Their Care Partners
A Phase 1 study testing Acceptance Commitment Therapy in people with Depression in Adults and Anxiety Disorder Generalized, run by Texas Tech University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Adults, Anxiety Disorder Generalized, Grief
- What is being tested?
- Acceptance Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+
- MMSE= 21-27
- Able to communicate in English
- 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
Who cannot join
- Currently in an intervention for reducing anxiety or depression related to their dementia
- MMSE= 28+ or less than 21
- MMSE= <28
- Is a formal (paid) caregiver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University Plaza Building
Lubbock, Texas, 79409-2051
Jonathan Singer, Ph.D., 7757228066, jonsinge@ttu.edu
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Depression in Adults, Anxiety Disorder Generalized, Grief
- Being tested
- Acceptance Commitment Therapy
- Keywords
- Mild Cognitive Impariment, Mild Neurocognitive Disorder, Dyadic intervention
- Medical subject headings
- Generalized Anxiety Disorder, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | 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. Receives: Behavioral: Acceptance Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9
PHQ-9 is used to assess the presence and severity of depressive symptoms.
Measured: 6 weeks
Geriatric Depression Short From
GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.
Measured: 6 Weeks
The Generalized Anxiety Disorder-7
GAD-7 is used to assess the severity of generalized anxiety symptoms
Measured: 6 weeks
General Anxiety Scale-10
The GAS-10 is designed to assess the severity of general anxiety symptoms
Measured: 6 Weeks
Pre-death grief-12
The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.
Measured: 6 weeks
Secondary outcomes (8)
Dyadic Coping Inventory
The DCI assess how couples support each other and cope together with stress.
Measured: 6 Weeks
Short Form Health Survey (SF-12)
The SF-12 measures functional health and well-being
Measured: 6 Weeks
Purpose in Life Scale
The PIL is designed to assess an individual's sense of meaning and purpose in life.
Measured: 6 Weeks
Herth Hope Index
The HHI is designed to measure an individual's level of hope
Measured: 6 Weeks
Inclusion of Other in the Self Scale
The IOS is designed to assess perceived closeness in interpersonal relationships
Measured: 6 Weeks
Perceived Stress Scale
The PSS is a measure the degree to which individuals perceive their lives as stressful
Measured: 6 Weeks
Pittsburgh Sleep Quality Index
The PSQI assess sleep quality and disturbances.
Measured: 6 Weeks
Repeatable Battery for the Assessment of Neuropsychological Status
The RBANS is a neuropsychological assessment designed to evaluate cognitive functioning
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Singer, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239609
- Sponsor's protocol ID
- TexasTechU7
- Acronym
- ACT
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not be providing any individual participant data. It will all be aggregate
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Individuals With MNCD and Their Care Partners: An In-Person and Telehealth Individual Therapy Approach
- ClinicalTrials.gov ID
- NCT07239609
- Acronym / sponsor ID
- ACT / TexasTechU7
- Conditions
- Depression in Adults, Anxiety Disorder Generalized, Grief
- Keywords
- Mild Cognitive Impariment, Mild Neurocognitive Disorder, Dyadic intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | Behavioral: Acceptance Commitment TherapyAcceptance 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18+
- MMSE= 21-27
- Able to communicate in English
- 18+
- Identifies as a care partner of a person with MNCD
Key exclusion criteria (4 listed)
- Currently in an intervention for reducing anxiety or depression related to their dementia
- MMSE= 28+ or less than 21
- MMSE= <28
- Is a formal (paid) caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance Commitment TherapyAcceptance 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. | Behavioural | Acceptance Commitment Therapy |
Primary outcome
Patient Health Questionnaire-9
Time frame: 6 weeks
PHQ-9 is used to assess the presence and severity of depressive symptoms.
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.
The Generalized Anxiety Disorder-7
Time frame: 6 weeks
GAD-7 is used to assess the severity of generalized anxiety symptoms
General Anxiety Scale-10
Time frame: 6 Weeks
The GAS-10 is designed to assess the severity of general anxiety symptoms
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. The investigators will not be providing any individual participant data. It will all be aggregate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acceptance Commitment Therapy in people with Depression in Adults and Anxiety Disorder Generalized, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Singer, Ph.D. (17757228066, jonsinge@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.