Psychoeducational Skills Training for Mild Cognitive Impairment

(EPICLA+ Trial)

Overseen By Dr. Gomez-Morales, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Disqualifiers: Hearing, Visual impairment, others

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

Compensation: Varies

Number of Visits: 12

Duration: 7 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with early-stage memory loss who live alone by offering an online psychoeducational skills training intervention. The sessions aim to reduce stress, improve well-being, address challenges, and assist participants in planning for the future. Participants will provide feedback to refine these programs for those experiencing early memory issues. Individuals with early-stage memory problems who can join Zoom sessions might find this trial suitable. As an unphased trial, this study presents a unique opportunity to contribute to the development of supportive interventions for memory loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing education and skills training rather than involving medication changes.

What prior data suggests that this psychoeducational skills training intervention is safe?

Research has shown that programs like EPICLA+, which teach skills and provide education, are generally easy for participants to handle. These programs assist people in managing early-stage memory loss. Studies indicate that this approach usually doesn't cause harmful side effects. Reports confirm that any side effects are minor and easy to manage. The program focuses on improving well-being, reducing stress, and planning for the future through online sessions, making it both convenient and safe. While some studies suggest these programs may not greatly enhance memory recall, they highlight other benefits like stress reduction and improved quality of life. Overall, joining such a program is considered safe and can be a helpful resource for those with mild memory challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the psychoeducational skills training intervention for mild cognitive impairment because it provides a personalized, interactive approach specifically designed for individuals with early-stage memory loss who live alone. Unlike traditional treatments like medication or general cognitive training, this program focuses on equipping participants with practical skills to manage stress, improve well-being, and plan for future challenges. Delivered via Zoom, it offers a convenient and accessible way for participants to engage in seven sessions, plus a booster session to reinforce learning, which is especially beneficial for those who may have difficulty accessing in-person support.

What evidence suggests that this psychoeducational skills training intervention is effective for early-stage memory loss?

Research has shown that programs like EPICLA+, which participants in this trial may receive, can boost mood and reduce everyday memory slips in people with mild memory problems. Similar treatments have helped participants feel less stressed and manage daily tasks more effectively. These programs focus on teaching skills that enhance well-being and assist with future planning. Although not all studies show significant improvements in thinking skills, learning these skills can promote independent living. Overall, these programs aim to help individuals maintain a better quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Dr. Gomez-Morales

Principal Investigator

ASU

Are You a Good Fit for This Trial?

This trial is for individuals living alone with early-stage memory loss, including mild cognitive impairment and early Alzheimer's disease. Participants should be able to use Zoom for virtual sessions aimed at improving their quality of life.

Inclusion Criteria

Must exhibit at least 2 of 8 changes caused by thinking and memory problems on the AD8 (a reliable and valid 8-item dementia screening tool)

I am 60 years old or older.

Must be a US resident

Exclusion Criteria

The participant demonstrates lack of skills with using a computer that precludes participation

The participant does not have a stable internet connection to connect to the video platform

I do not have severe hearing or vision problems that would stop me from joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants attend six group sessions and one individualized session via Zoom to learn strategies for handling new situations, reducing stress, improving mood, communicating better with others, and planning for the future.

7 weeks

7 visits (virtual)

Booster Session

Participants attend a booster session to reinforce skills and lessons learned during the treatment phase.

1 week

1 visit (virtual)

Follow-up

Participants are monitored for feedback and program improvement through interviews at the start, and again about 3 and 6 months.

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psychoeducational skills training intervention

Trial Overview The EPICLA+ project tests a psychoeducational skills training intervention delivered via Zoom. It focuses on reducing stress, enhancing well-being, managing daily challenges, and future planning for those with early-stage memory loss.

How Is the Trial Designed?

Group I: EPICLA+ Experimental Treatment 1 Intervention

Group EPICLA+ will start the intervention immediately after assessment 1. The EPICLA+ program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to assist people with early-stage memory loss that live alone in the community by providing early-stage-related education and skill-training sessions to reduce stress, enhance well-being, manage challenges, and plan for the future. Following the 7 EPIC sessions, participants will attend a booster session, held via Zoom, to reinforce the skills/lessons.

Group II: Wait List Control (WLC) Active Control 1 Intervention

The WLC group will start the intervention after 3 months of the EPICLA+ group start date, once T2 assessment is completed.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The process-based multi-task adaptive cognitive training (P-bM-tACT) program significantly improved executive function and other cognitive domains in older adults with mild cognitive impairment (MCI) over a 10-week period, with effects maintained for 3 months after training.

The program was well-received, demonstrating a high adherence rate of 83.4%, indicating its acceptability as a viable intervention for enhancing cognitive function in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transferability and sustainability of process-based multi-task adaptive cognitive training in community-dwelling older adults with mild cognitive impairment: a randomized controlled trial. Zhao, X., Ji, C., Zhang, C., et al.[2023]

In a study involving two older adults with Amnestic Mild Cognitive Impairment, cognitive training led to improved performance on untrained measures of attention and reasoning for one participant after 40 training sessions.

Both participants reported fewer cognitive failures in daily life and improved mood after completing the training, suggesting potential benefits of cognitive training beyond the specific tasks practiced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single case study of computerised cognitive training for older persons with mild cognitive impairment. Finn, M., McDonald, S.[2018]

The psychoeducational intervention aimed at improving family caregiver skills was found to be safe and acceptable, with some participants showing improvements in self-efficacy, mental health, anxiety, and depression after the intervention.

However, only 4 out of 9 caregivers completed the program, indicating that the intervention needs refinement to enhance feasibility and adherence among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Family Caregiver Skills Using a Simulation-Based Intervention: A Randomized Pilot Trial. Mazanec, SR., Sandstrom, K., Coletta, D., et al.[2020]

The study involved 66 older adults with mild cognitive impairment (MCI) who participated in a virtual interactive working memory training (VIMT) program, showing a significant improvement in working memory compared to an active control group after 36 training sessions.

The VIMT program not only helped maintain working memory but also potentially reduced cognitive decline in older adults with MCI, indicating its efficacy as an intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Yang, HL., Chu, H., Kao, CC., et al.[2020]

The HABIT® program, which includes various interventions like wellness education and yoga, significantly improves quality of life and mood for individuals with mild cognitive impairment (pwMCI), especially when wellness education is included.

Cognitive training (CCT) was found to have the most substantial effect on cognitive function, while yoga improved functional status and reduced caregiver burden, suggesting that a combination of these interventions tailored to patient preferences could optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. Levy, SA., Smith, G., De Wit, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06962111

Early-Stage Partner in Care Living Alone Plus (EPICLA+) The EPICLA+ program consists of a 7-session, psychoeducational skills training intervention, held via Zoom, designed to assist people with early-stage memory ...

2. withpower.com withpower.com/trial/phase-cognitive-dysfunction-3-2025-216e7

Psychoeducational Skills Training for Mild Cognitive ... Research shows that similar treatments, like cognitive training and health education, can improve mood and reduce cognitive failures in everyday life for people ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8482982/

Prevention of and Early Intervention for Cognitive Decline ... This study found no significant benefit of the intervention, but investigators speculated that the lack of dementia prevention may have ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2761651

Screening for Cognitive Impairment in Older Adults: US ... Incidence and outcome of mild cognitive impairment in a population-based prospective cohort. Neurology. 2002;59(10):1594-1599. doi:10.1212 ...

5. nature.com nature.com/articles/s41598-023-44771-7

Effectiveness of exercise interventions to improve long ... Effectiveness of exercise interventions to improve long-term outcomes in people living with mild cognitive impairment: a systematic review and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3943830/

A systematic review of treatments for Mild Cognitive ... Ten sessions of memory training, psychoeducation and relaxation did not improve recall on secondary outcomes in one small 6-month trial. Short term (6 week) ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2761650

Screening for Cognitive Impairment in Older Adults ... There is no empirical evidence, however, that screening for cognitive impairment improves patient or caregiver outcomes or causes harm.

8. researchgate.net researchgate.net/publication/354991182_Prevention_of_and_Early_Intervention_for_Cognitive_Decline_Due_to_Alzheimer's_Disease_and_Related_Disorders

Prevention of and Early Intervention for Cognitive Decline ... Recent research across disciplines suggest that prevention might be more effective than treatment once cognitive impairment is evident (Barnett et al., 2014; ...