Alexa Program for Depression

Overseen By Allison Carroll, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cognitive impairment, No Wi-Fi, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new voice-assisted program using Amazon Alexa to help manage depression, known as the VIPA Treatment Program. Participants will use Alexa for goal setting, reminders, and other services, with some receiving extra guidance to maximize the program's benefits. The study lasts 12 weeks and involves completing surveys about the experience. It suits adults 65 or older with depression who have Wi-Fi and can understand English. Caregivers supporting older adults may also participate. As an unphased trial, this study offers a unique opportunity to explore innovative technology for managing depression.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 using a voice-assisted program for mental health management, so it's unlikely that medication changes are required.

What prior data suggests that this voice-assisted program is safe for mental health management?

Research has shown that voice-activated personal assistants, like Amazon Alexa, are being explored for mental health support. These tools can provide reminders and prompts that might help people manage depression. The VIPA Treatment Program uses Alexa in this way.

Specific study data on the safety of the VIPA program itself is not available. However, using Alexa for mental health does not involve medication or medical procedures, suggesting minimal risk.

Other studies on voice assistants have found them generally easy to use and helpful for managing tasks or routines. No major safety concerns have been reported in similar setups with voice assistants.

Prospective participants should discuss any concerns with the research team. They can provide more details about what to expect and how they ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VIPA Treatment Program is unique because it leverages a digital mental health intervention using an Amazon Alexa device to support older adults with depression. Unlike traditional treatments, such as medication or in-person therapy, this program offers a new way to engage with mental health support through voice-activated technology, making it more accessible and user-friendly for seniors. Researchers are excited about this approach because it combines convenience with innovative technology, potentially reaching individuals who face barriers to accessing conventional mental health care. This method aims to enhance patient engagement and adherence, offering a personalized and interactive experience that stands out from standard treatment options.

What evidence suggests that the VIPA Treatment Program could be effective for depression?

Research has shown that voice-activated personal assistants like Amazon Alexa can help manage depression, particularly in older adults. In this trial, participants in the Digital Mental Health Intervention (DMHI) arm will receive an Amazon Alexa device with the newly designed VIPA treatment program installed. One study found that these devices can suggest simple activities to encourage positive behavior, potentially reducing depression symptoms. Older adults who stay at home often struggle to access mental health resources, and these voice assistants provide an easy and supportive option. Early results suggest that using these devices can help users set daily goals and remind them to practice positive habits, improving their mood over time. While more research is needed, the initial findings are promising for those seeking new ways to manage depression at home. ^{1 2 3 4 5}

Who Is on the Research Team?

David C Mohr, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 65 or older with depression (PHQ-9 score ≥10), who are cognitively sound (MOCA score ≥24), homebound, and have Wi-Fi. It also includes their caregivers who are over 18 and provide at least two hours of weekly support. Participants must be able to consent.

Inclusion Criteria

I am over 18, speak English, support someone over 65, have Wi-Fi, and can consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use Amazon Echo Show 8 and the VIPA program for goal setting, reminders, and mood improvement

8 weeks

Regular virtual check-ins with a caregiver or coach

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Surveys and assessments completed virtually

What Are the Treatments Tested in This Trial?

Interventions

• VIPA Treatment Program

Trial Overview The study tests a voice-assisted program using Amazon Alexa aimed at managing mental health in older adults. Over 16 weeks, participants will use the program with or without a guidebook and complete surveys about their experience.

How Is the Trial Designed?

Group I: Digital Mental Health Intervention (DMHI) Experimental Treatment 1 Intervention

Participants randomized to Arm 1 will be sent an Amazon Alexa device, with a newly designed VIPA treatment program installed, and will receive a guidebook to help the older adult understand the device and utilize the VIPA treatment program to its fullest potential.

Group II: Control Treatment (CT) Active Control 1 Intervention

Participants randomized to Arm 2 will be sent an Amazon Alexa device with guidebook to help the older adult understand how to use the device.

VIPA Treatment Program is already approved in United States for the following indications:

Approved in United States as VIPA Treatment Program for:

• Depression management among older adults

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study of 14 patients with epilepsy, 28.57% experienced mild cognitive impairment (MCI) after starting valproic acid (VPA) therapy, indicating a potential link between VPA and cognitive issues.

Discontinuing VPA led to clinical improvement in four out of five patients with cognitive impairment, suggesting that VPA may contribute to cognitive dysfunction regardless of dosage or ammonia levels in the blood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYPERAMMONAEMIA AND COGNITIVE IMPAIRMENT IN EPILEPSY PATIENTS TREATED WITH VALPROIC ACID - PRELIMINARY STUDY. Szczygieł-Pilut, EE., Zajączkowska-Dutkiewicz, A., Pilut, D., et al.[2022]

In a study of 100,000 VA patients undergoing depression treatment, it was found that patients experienced less than one high-risk period for suicide each year, but they averaged only 2.4 monitoring visits after antidepressant changes and 4.9 visits after psychiatric hospitalization.

Implementing intensive monitoring during all high-risk periods would be costly, estimated at $183-$270 million annually, but focusing on monitoring after psychiatric hospitalizations alone could be a more feasible option, costing $15-$17 million.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service implications of providing intensive monitoring during high-risk periods for suicide among VA patients with depression. Valenstein, M., Eisenberg, D., McCarthy, JF., et al.[2022]

A 60-year-old female patient developed severe neurological symptoms, including tremor, rigidity, and cognitive impairment, after 16 years of treatment with the antiepileptic drug valproate (VPA).

After stopping VPA, the patient fully recovered her cognitive functions and physical abilities, highlighting that VPA-induced encephalopathy, although rare, is a serious side effect that should be monitored in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Valproate can induce reversible encephalopathy]. Prakash, S., Harbo, T., Christensen, J.[2017]

In a study of 162 adult inpatients receiving valproic acid (VPA), 20.4% developed hyperammonemia, indicating a significant risk associated with this medication.

Among those with hyperammonemia, 16.0% exhibited symptoms, and 8.0% were diagnosed specifically with VPA-induced hyperammonemia, highlighting the need for monitoring ammonia levels in patients on VPA, especially if they show signs of altered mental status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperammonemia in patients receiving valproic acid in the hospital setting: A retrospective review. McMorris, T., Chu, A., Vu, L., et al.[2022]

In a study assessing four voice assistants (Apple Siri, Amazon Alexa, Google Assistant, and Microsoft Cortana) for their responses to postpartum depression (PPD) questions, the best performing assistant provided clinically appropriate advice only 29% of the time, indicating a significant gap in effective support for users seeking help.

All voice assistants demonstrated high accuracy in recognizing PPD-related queries (79% to 100%), but none provided adequate clinical advice, highlighting the need for collaboration between technology companies and healthcare organizations to enhance the quality of health information delivered through these platforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Advice by Voice Assistants on Postpartum Depression: Cross-Sectional Investigation Using Apple Siri, Amazon Alexa, Google Assistant, and Microsoft Cortana. Yang, S., Lee, J., Sezgin, E., et al.[2023]

In a study of 793 patients treated with valproate, 2.52% were found to have symptoms of valproate-induced hyperammonemic encephalopathy (VHE), suggesting it may be more common in psychiatric patients than previously thought.

Despite the recognition of VHE, treatment was often inadequate; only 40% of patients had valproate discontinued, and lactulose, the primary ammonia-lowering treatment, was used in only a few cases, highlighting the need for increased awareness and better management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valproate-Induced Hyperammonemic Encephalopathy in General Hospital Patients With One or More Psychiatric Disorders. Lewis, C., Tesar, GE., Dale, R.[2022]

A study involving 41 patients demonstrated that a voice-based delivery system of the PHQ 9 using Amazon Alexa is highly reliable, with a reliability score of α = .86, comparable to the traditional paper version.

Patients showed a strong preference for the Alexa format, with 85.7% expressing willingness to use it at home, suggesting that this innovative approach could enhance the usability and engagement in monitoring depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within Clinic Reliability and Usability of a Voice-Based Amazon Alexa Administration of the Patient Health Questionnaire 9 (PHQ 9). Beaman, J., Lawson, L., Keener, A., et al.[2022]

The study found that stroke patients with depressive symptoms were able to engage with an automated interactive voice response (IVR) system, completing 74% of weekly assessments, indicating good feasibility for this monitoring approach.

The IVR system not only supported self-management of depression but also facilitated communication with caregivers and primary care providers, with notifications sent for critical issues like suicidal ideation and medication non-adherence, highlighting its potential for improving post-stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-An Innovative Approach to Post-Stroke Depression Self-Management Support. Skolarus, LE., Piette, JD., Pfeiffer, PN., et al.[2018]

The study demonstrated that using interactive voice response (IVR) technology to screen for depression is feasible among low-income, urban pregnant women, with all 54 participants successfully completing the screening process.

About 29.6% of participants scored in the moderate to severe range for depressive symptoms, indicating a significant need for mental health support, although most preferred to discuss their issues with social workers or obstetricians rather than mental health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated depression screening in disadvantaged pregnant women in an urban obstetric clinic. Kim, H., Bracha, Y., Tipnis, A.[2016]

In a study of 104 patients at a public sector women's clinic, 38% were found to have current major depressive episodes (MDEs), highlighting the high prevalence of depression in this setting.

Computerized voice recognition for depression screening was found to be as effective as live interviews, with strong agreement in results, suggesting it could be a reliable tool for identifying depression in both English and Spanish speakers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression screening in a women's clinic: using automated Spanish- and English-language voice recognition. Muñoz, RF., McQuaid, JR., González, GM., et al.[2021]

In a randomized, double-blind study of 135 patients with BP-II depression, adding memantine to valproate treatment did not significantly improve depression or mania symptoms compared to valproate plus placebo.

However, the addition of memantine significantly increased levels of high-density lipoprotein cholesterol (HDL-C), suggesting a potential metabolic benefit even without changes in mood symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Add-on memantine to valproate treatment increased HDL-C in bipolar II disorder. Lee, SY., Chen, SL., Chang, YH., et al.[2022]

Voice assistants (VAs) show promise in promoting healthy lifestyle behaviors across various populations, as indicated by a scoping review of 10 studies that explored their use in behavioral health interventions.

Most interventions using VAs were multicomponent and involved various behavior change techniques, but many studies are still in early development stages, highlighting the need for more rigorous efficacy trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of patient-facing, behavioral health interventions with voice assistant technology targeting self-management and healthy lifestyle behaviors. Sezgin, E., Militello, LK., Huang, Y., et al.[2021]

The COPE self-help program, which included treatment booklets and telephone calls to an Interactive Voice Response system, showed significant improvements in depression symptoms, with a 41% reduction in Hamilton Rating Scale for Depression scores among participants after 12 weeks.

Out of the 41 patients, 68% completed the program, and 64% of those completers were considered responders, indicating that this self-help approach can be an effective alternative for individuals with mild-to-moderate depression who may not have access to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered psychotherapy for depression using a telephone-accessed computer system plus booklets: an open U.S.-U.K. study. Osgood-Hynes, DJ., Greist, JH., Marks, IM., et al.[2019]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06114485

Voice Activated Personal Assistant for Depression Among ... ... Amazon Alexa to test a new voice-assisted program for mental health management. ... behavioral activation prompts to older adults with depression. Through ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11262314/

Voice Assistants for Mental Health Services: Designing ... The number of older adults who are homebound with depressive symptoms is increasing. Due to their homebound status, they have limited access ...

4. trialx.com trialx.com/clinical-trials/listings/289450/voice-activated-personal-assistant-for-depression-among-older-adults/

Voice Activated Personal Assistant for Depression Among ... Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The older adult and their support ...

5. withpower.com withpower.com/trial/alexa-program-for-depression-c56d1

Alexa Program for Depression · Info for Participants This N/A medical study run by Northwestern University needs participants to evaluate whether VIPA Treatment Program will have tolerable side effects ...