Group Psychotherapy for Mild Cognitive Impairment

(MIND-MCI Trial)

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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Impairment (MCI). The main questions it aims to answer are: * is the video therapy user-friendly for veterans? * does it improve veterans well-being and quality-of-life? Veterans will be asked to attend nine 1 hour small group video sessions and will complete questionnaires before and after the sessions. Researchers will compare the group of veterans that starts the video sessions right away with a group that waits before starting the video sessions.

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 data supports the effectiveness of group psychotherapy delivered via video telehealth for mild cognitive impairment?

Research shows that cognitive behavioral therapy (CBT) delivered via telehealth can effectively reduce anxiety in people with mild cognitive impairment (MCI) and dementia. Additionally, social interactions, like those in group therapy, have cognitive and emotional benefits for older adults with MCI, suggesting that video-based group psychotherapy could be beneficial. ^{1 2 3 4 5}

Is video-based group psychotherapy safe for humans?

Research on video-based group therapy for caregivers and older adults with mild cognitive impairment suggests it is generally safe, with participants reporting positive experiences and no negative effects. ^{3 4 6 7 8}

How is group psychotherapy via video telehealth different from other treatments for mild cognitive impairment?

Group psychotherapy via video telehealth is unique because it allows people with mild cognitive impairment to participate in therapy sessions from their own homes using video calls. This approach is particularly beneficial for those who may have difficulty traveling to in-person sessions, and it provides a way to connect with others facing similar challenges, which can be supportive and comforting. ^{1 2 3 9 10}

Research Team

Patricia Pilkinton, MD

Principal Investigator

Tuscaloosa Veterans Affairs Medical Center

Lindsay Jacobs, PhD

Principal Investigator

Tuscaloosa Veterans Affairs Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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]

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 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]

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]

References

1. England 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. [2023]

2. England 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. [2018]

3. England 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Providing a Purposeful and Stimulating Volunteer Opportunity for Older Adults With Mild Cognitive Impairment: A Pilot Study. [2023]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Communication Bridge: A pilot feasibility study of Internet-based speech-language therapy for individuals with progressive aphasia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Video-Enhanced Care Management for Medically Complex Older Adults with Cognitive Impairment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Use of a multiparty web based videoconference support group for family caregivers: Innovative practice. [2022]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of multidisciplinary telehealth evaluations in atypical dementia. [2022]