Group Psychotherapy for Mild Cognitive Impairment

(MIND-MCI Trial)

Not currently recruiting at 1 trial location

Overseen By Lindsay Jacobs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tuscaloosa Research & Education Advancement Corporation

Must not be taking: Psychotropics, Memory medications

Disqualifiers: Dementia, Schizophrenia, Bipolar, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether group psychotherapy delivered via video telehealth can help veterans with Mild Cognitive Impairment (MCI) feel better and improve their quality of life. The researchers aim to determine if this home-based video therapy is user-friendly and beneficial for veterans. Participants will join nine weekly, one-hour group sessions online. Veterans who have noticed memory problems and have a cardiovascular condition, such as high blood pressure or diabetes, might be a good fit for this trial. As an unphased trial, it offers veterans the opportunity to access innovative therapy from home, potentially enhancing their well-being.

Will I have to stop taking my current medications?

Participants will need to stay on their current dosages of psychotropic medications and medications for memory and cognition for the duration of the study.

What prior data suggests that this group psychotherapy via video telehealth is safe for veterans with Mild Cognitive Impairment?

Research shows that video-based group therapy is generally safe and well-tolerated. One study found that group therapy through video calls works as effectively as in-person sessions. This indicates that people usually manage it well without unexpected problems. Another study demonstrated that using video calls for therapy is both practical and acceptable, meaning people find it easy to use and are comfortable with it.

Although these studies focus on different conditions, therapy through video has proven to be a safe way to help people. This is encouraging for those considering joining a trial using video therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using group psychotherapy via video telehealth for mild cognitive impairment because it offers a unique delivery method that is accessible from home. Unlike traditional in-person therapy sessions, this approach eliminates the need for travel, making it convenient for those with mobility issues or living in remote areas. Additionally, the waitlist control group allows for comparison between immediate and delayed therapy, helping to determine the effectiveness of timely intervention. This innovative use of technology could potentially expand the reach of cognitive therapy to more people who need it.

What evidence suggests that group psychotherapy delivered via video telehealth is effective for mild cognitive impairment?

Research shows that group therapy sessions over video calls can benefit people with memory and thinking problems. Studies have found that this therapy can reduce anxiety and is well-received by participants. In this trial, participants will receive group therapy via video telehealth, either immediately or after a waiting period. For individuals with mild memory issues, similar video sessions have been tested to enhance mental health and improve quality of life. Additionally, video calls provide a convenient way for veterans to access therapy without leaving home. These findings suggest that this method could enhance well-being for those with mild memory problems. ^{3 6 7 8 9}

Who Is on the Research Team?

Patricia Pilkinton, MD

Principal Investigator

Tuscaloosa Veterans Affairs Medical Center

Lindsay Jacobs, PhD

Principal Investigator

Tuscaloosa Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking veterans aged 60 or older with Mild Cognitive Impairment (MCI) diagnosed at least a month prior. Participants must have one cardiovascular risk factor like hypertension, diabetes type II, high cholesterol, or obesity and feel their memory/thinking issues impact their life.

Inclusion Criteria

You can speak English and can sign a paper agreeing to participate in the study.

I have been diagnosed with a condition like high blood pressure, type 2 diabetes, high cholesterol, or obesity.

I was diagnosed with mild cognitive impairment over a month ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nine weekly 60-minute group therapy sessions via telehealth

9 weeks

9 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Group psychotherapy delivered via video telehealth

Trial Overview The study tests if a 9-week group psychotherapy via video telehealth can improve the well-being and quality of life for veterans with MCI. It compares immediate participation in therapy to a delayed start, using questionnaires before and after sessions to measure outcomes.

How Is the Trial Designed?

Group I: Group therapy delivered via video telehealth - wait list control Experimental Treatment 1 Intervention

Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period.

Group II: Group therapy delivered via video telehealth Experimental Treatment 1 Intervention

Nine sessions of 60 min each group therapy delivered via telehealth

Group psychotherapy delivered via video telehealth is already approved in United States for the following indications:

Approved in United States as Group psychotherapy delivered via video telehealth for:

• Mild Cognitive Impairment (MCI)

Who Is Running the Clinical Trial?

Tuscaloosa Research & Education Advancement Corporation

Lead Sponsor

Trials

15

Recruited

2,300+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The Tech-CBT study is the first trial to assess a technology-assisted cognitive behavioral therapy (CBT) intervention for reducing anxiety in individuals with mild cognitive impairment (MCI) and dementia, involving 70 participants split between the intervention and usual care groups.

The study aims to evaluate not only the efficacy of the Tech-CBT intervention in reducing anxiety but also its cost-effectiveness and acceptability, potentially improving access to psychological treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. Dissanayaka, N., Brooks, D., Worthy, P., et al.[2023]

Telehealth services for cognitive and neurologic assessments in patients with atypical neurodegenerative syndromes were found to be feasible, with 104 patient-carepartner dyads participating in video consultations during 2020.

Patient-carepartners reported high satisfaction with telehealth visits, with 93% willing to participate in future remote appointments, indicating that telehealth could enhance accessibility to multidisciplinary care for complex dementia cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of multidisciplinary telehealth evaluations in atypical dementia. Wong, B., Loyer, E., Sullivan, C., et al.[2022]

A secure telehealth videoconferenced support group was developed specifically for rural spouses caring for individuals with atypical and early-onset dementias, addressing the unique challenges faced by these caregivers.

Preliminary evidence suggests that this technology-facilitated intervention is effective, providing a valuable resource for caregivers who often lack access to traditional support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a telehealth videoconferenced support group for rural spouses of individuals diagnosed with atypical early-onset dementias. O'Connell, ME., Crossley, M., Cammer, A., et al.[2019]

A cognitive behavioural group therapy program for 22 patients with mild cognitive impairment and their significant others showed promising preliminary results, particularly in increasing acceptance among patients and awareness of memory issues among caregivers.

Despite no significant changes in distress or mood, the high attendance rate suggests strong motivation for participation, indicating that the program is feasible and warrants further investigation with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioural group therapy for patients diagnosed with mild cognitive impairment and their significant others: feasibility and preliminary results. Joosten-Weyn Banningh, LW., Kessels, RP., Olde Rikkert, MG., et al.[2018]

A 10-session cognitive behavioral therapy program for patients with mild cognitive impairment (MCI) showed lasting benefits, as patients maintained increased acceptance and insight into their condition 6 to 8 months after the intervention.

While MCI patients and their significant others reported worse feelings of helplessness and wellbeing at follow-up, the significant others experienced an increased sense of competence, suggesting the need for ongoing support after the therapy program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of group therapy for patients with mild cognitive impairment and their significant others: a 6- to 8-month follow-up study. Joosten-Weyn Banningh, LW., Roelofs, SC., Vernooij-Dassen, MJ., et al.[2020]

A 6-week program connecting older adults with mild cognitive impairment (MCI) to English language learners through videoconferencing showed high engagement, with 78% of scheduled sessions completed and only 7% missed.

Participants reported feeling comfortable and engaged during conversations, indicating that this intervention is both feasible and potentially beneficial for reducing loneliness and isolation in older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing a Purposeful and Stimulating Volunteer Opportunity for Older Adults With Mild Cognitive Impairment: A Pilot Study. Piette, JD., Roberts, JS., Marinec, N., et al.[2023]

A study involving 34 participants with progressive aphasia due to dementia demonstrated that telepractice for speech-language therapy (SLT) is feasible and effective, with 31 participants completing the 6-month evaluation.

Participants showed significant functional gains and increased confidence in communication, which were maintained at 6 months post-therapy, indicating the potential long-term benefits of Internet-based SLT for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Bridge: A pilot feasibility study of Internet-based speech-language therapy for individuals with progressive aphasia. Rogalski, EJ., Saxon, M., McKenna, H., et al.[2022]

A pilot study involving five caregivers of individuals with dementia showed that a weekly web-based videoconference support group was positively received, with participants reporting improvements in anxiety, depression, and physical health.

The study suggests that this online support format is a feasible and low-cost alternative to in-person meetings, effectively reducing barriers to attendance and enhancing caregivers' self-efficacy in managing challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a multiparty web based videoconference support group for family caregivers: Innovative practice. Austrom, MG., Geros, KN., Hemmerlein, K., et al.[2022]

A pilot study involving 39 older adults with mild cognitive impairment (MCI) showed that visual art therapy (VAT) can improve psychological well-being, as indicated by significant changes in depression scores, while both VAT and health education led to cognitive improvements.

Participants in the VAT group reported initial challenges but ultimately found the therapy beneficial for their cognitive and psychosocial health, suggesting that VAT is a feasible and potentially effective intervention for older adults with MCI and low literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Visual Art Therapy Be Implemented With Illiterate Older Adults With Mild Cognitive Impairment? A Pilot Mixed-Method Randomized Controlled Trial. Masika, GM., Yu, DSF., Li, PWC.[2021]

A pilot study involving 40 older veterans with suspected mild cognitive impairment showed that video-enhanced care management was feasible and preferred over traditional telephone calls, with higher completion rates and better engagement reported in the video group.

Participants who were familiar with technology rated the usability of the video platform higher, suggesting that comfort with technology can enhance the effectiveness of video telehealth interventions for managing complex health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Enhanced Care Management for Medically Complex Older Adults with Cognitive Impairment. Hastings, SN., Mahanna, EP., Berkowitz, TSZ., et al.[2022]

Citations

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Telehealth Rehabilitation for Cognitive Impairment This study investigated the feasibility and acceptability of delivering cognitive rehabilitation to individuals with subjective cognitive impairment (SCI), MCI, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37340492/

study protocol for a randomised trial This is the first trial to evaluate a novel technology-assisted CBT intervention to reduce anxiety in people living with MCI and dementia.

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Telehealth Cognitive Behavior Therapy to Reduce Anxiety ... Videoconference-delivered CBT has shown reduced anxiety symptoms and acceptability in people with anxiety disorders (Hailey et al., Citation2008 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05690243/minds-navigating-the-diagnosis-of-mild-cognitive-impairment

Minds Navigating the Diagnosis of Mild Cognitive Impairment The goal of this clinical trial is to find out if a 9 week group therapy using video from home will help veterans with Mild Cognitive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666606524001366

Clinical and cost-effectiveness of remote-delivered, online ... Participants were assigned to six 90-min sessions over 8-weeks using group-based, online videoconferencing comprising: (1) lifestyle therapy (targeting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7954114/

Feasibility and Initial Outcomes of a Group-Based ... Video teleconferencing group psychotherapy and support have been shown to be feasible and have produced similar outcomes to in-person care while ...

7. researchprotocols.org researchprotocols.org/2018/2/e43/

Telehealth Rehabilitation for Cognitive Impairment This study investigated the feasibility and acceptability of delivering cognitive rehabilitation to individuals with subjective cognitive ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015654/

The effects of telehealth-delivered mindfulness meditation, ... Group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access.

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07381-2

study protocol for a randomised trial This is the first trial to evaluate a novel technology-assisted CBT intervention to reduce anxiety in people living with MCI and dementia.