Acceptance Commitment Therapy for Major Neurocognitive Disorder

(ACT Trial)

Overseen By Jonathan Singer, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Texas Tech University

Disqualifiers: Formal caregiver, Anxiety intervention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Acceptance Commitment Therapy (ACT) for individuals with major neurocognitive disorders, such as Alzheimer's, and their care partners. ACT encourages acceptance of difficult thoughts and feelings while focusing on personal values and making positive behavior changes. The trial aims to determine if this therapy is practical and beneficial for both patients and their care partners. Suitable candidates include those diagnosed with mild cognitive impairment or a major neurocognitive disorder, along with their family members or friends who assist in their care. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently in an intervention for reducing anxiety or depression related to dementia, you may not be eligible to participate.

What prior data suggests that this therapy is safe for individuals with major neurocognitive disorder?

Research has shown that Acceptance Commitment Therapy (ACT) is generally easy for people to handle. Studies have found that ACT helps individuals become more adaptable when dealing with challenging thoughts and feelings. For example, a review found that ACT can reduce anxiety and depression, particularly in caregivers of people with dementia. This suggests that ACT might be safe and helpful for those facing stress and emotional difficulties.

Another study found that ACT could enhance cognitive functions such as thinking, learning, and memory. These findings suggest that ACT may offer mental health benefits without causing harm. While specific details about side effects are not available, ACT, as a form of talk therapy, is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Acceptance Commitment Therapy (ACT) is unique because it focuses on enhancing psychological flexibility rather than trying to eliminate difficult thoughts and feelings. Unlike standard treatments for major neurocognitive disorders, which often involve medications aiming to slow cognitive decline, ACT encourages individuals to accept their thoughts and emotions while committing to behavior changes aligned with their personal values. Researchers are excited about ACT because it offers a non-pharmacological approach that may improve quality of life by helping individuals adapt to cognitive challenges more effectively.

What evidence suggests that Acceptance Commitment Therapy might be an effective treatment for Major Neurocognitive Disorder?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial will receive, can improve mental health and thinking skills. Studies have found that ACT lowers anxiety, depression, and stress for those caring for someone with dementia. This therapy teaches individuals to accept difficult thoughts and feelings while taking actions aligned with their personal values. ACT has also reduced anxiety and burnout among healthcare workers. Overall, ACT is a proven method that enhances mental flexibility and well-being. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate memory or thinking problems (MMSE score 21-27) and their family members or friends who help care for them (care partners, MMSE score 28-30). Both must be able to communicate in English.

Inclusion Criteria

I am 18 years old or older.

My memory and thinking skills score is between 21 and 27.

I can communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acceptance Commitment Therapy (ACT) to enhance psychological flexibility through six core processes

6 weeks

In-person and telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance Commitment Therapy

Trial Overview

The study is testing Acceptance Commitment Therapy (ACT), a type of talk therapy, delivered together to people with memory issues and their care partners. The goal is to see if this joint approach helps with grief, depression, and anxiety.

How Is the Trial Designed?

Group I: Acceptance Commitment Therapy Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12983781/

Effects of acceptance and commitment therapy for family ...

The results indicated that ACT was effective in improving psychological health. Another review included 21 studies (10 on dementia ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10015206/

Effects of acceptance and commitment therapy on cognitive ...

The results of this study show that ACT intervention can improve cognitive function. Synthesizing data from this review found that two factors may have an ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/capr.12646

Acceptance and commitment therapy (ACT) for people with ...

This study aimed to investigate the effectiveness and acceptability of acceptance and commitment therapy (ACT) for people with dementia.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05749939

Acceptance Commitment Therapy for Caregivers of People ...

... ACT intervention is effective in improving relevant caregiver outcomes. While the 2021 pilot demonstrated that ACT could improve caregivers outcomes, the ...

5.

tandfonline.com

tandfonline.com/doi/abs/10.1080/07317115.2021.1920530

Effectiveness of Acceptance and Commitment Therapy ...

Acceptance and Commitment Therapy showed positive effects in healthcare professionals working with dementia by reducing anxiety and burnout.

6.

emerald.com

emerald.com/jap/article/26/3/140/1220158/Feasibility-and-acceptability-of-an-acceptance-and

Feasibility and acceptability of an ... - Emerald Publishing

The present study aimed to investigate the feasibility and acceptability of an ACT intervention tailored for caregivers of dementia patients experiencing ...

7.

researchgate.net

researchgate.net/publication/396944244_The_effects_of_acceptance_and_commitment_therapy_on_anxiety_depression_and_process_measures_in_informal_caregivers_of_people_with_dementia_a_systematic_review_and_meta-analysis

The effects of acceptance and commitment therapy on ...

Conclusion: ACT may be effective in reducing anxiety, depression, and experiential avoidance in informal caregivers of PwD. Future researchers are encouraged to ...