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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The participant will use this program to help with goal setting, reminders, and various other services. The participant may be supported by a caregiver, if available, or by research team member who will serve as a coach for the duration of the study to guide them with using the program. Participants will be asked to complete surveys and assessments about their experiences during the 12-week study period. Participants will be randomized into two groups: those who receive a guide to help them with utilization of the program to its fullest potential and those who do not receive that guide.

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 data supports the idea that Alexa Program for Depression is an effective treatment?

The available research shows that the Alexa Program for Depression is reliable and well-received by users. In a study where patients used Alexa to complete a depression questionnaire, the results were consistent with traditional paper methods, showing high reliability. Additionally, 85.7% of participants expressed a willingness to use Alexa at home, indicating a positive user experience. Compared to other treatments like Interactive Voice Response systems, which also support depression management, Alexa's voice-based system is preferred by users for its attractiveness and novelty. ^{1 2 3 4 5}

What data supports the effectiveness of the Alexa Program for Depression treatment?

Research shows that voice assistants like Amazon Alexa can reliably deliver mental health assessments, such as the PHQ 9 for depression, with high user satisfaction. Additionally, similar voice-based systems have been effective in supporting self-management of depression in other contexts, like post-stroke care. ^{1 2 3 4 5}

What safety data exists for the Alexa Program for Depression?

The available research does not directly address safety data for the Alexa Program for Depression. However, studies on voice assistant technology, including Amazon Alexa, suggest high reliability and positive user experience in administering mental health assessments like the PHQ 9. These studies indicate a preference for voice-based formats over traditional methods, but they do not provide specific safety data for the Alexa Program for Depression. Further research is needed to evaluate the safety and efficacy of this specific treatment program. ^{1 2 6 7 8}

Is the Alexa Program for Depression safe for humans?

Research on using Amazon Alexa for mental health, like depression, shows it is reliable and users generally have positive experiences with it. However, detailed safety data specific to the Alexa Program for Depression is not available, but studies suggest it is well-received and usable. ^{1 2 6 7 8}

Is the VIPA Treatment Program a promising treatment for depression?

The VIPA Treatment Program, which uses a voice-activated personal assistant like Amazon Alexa, is a promising treatment for depression among older adults. It offers a new way to manage mental health by providing support and interaction, which can be especially helpful for those who may feel isolated or have difficulty accessing traditional therapy. ^{9 10 11 12 13}

How is the Alexa Program for Depression different from other treatments for depression?

The Alexa Program for Depression is unique because it uses a voice-activated personal assistant, like Amazon Alexa, to help manage mental health, which is different from traditional treatments that typically involve medication or face-to-face therapy sessions. ^{9 10 11 12 13}

Research Team

David C Mohr, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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 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 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 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 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]

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]

References

1. Canada 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. [2023]

2. United States 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). [2022]

3. United States 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. [2019]

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

Interactive Voice Response-An Innovative Approach to Post-Stroke Depression Self-Management Support. [2018]

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

Depression screening in a women's clinic: using automated Spanish- and English-language voice recognition. [2021]

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

Service implications of providing intensive monitoring during high-risk periods for suicide among VA patients with depression. [2022]

7. England 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. [2021]

8. Austria pubmed.ncbi.nlm.nih.gov

Automated depression screening in disadvantaged pregnant women in an urban obstetric clinic. [2016]

9. Poland pubmed.ncbi.nlm.nih.gov

HYPERAMMONAEMIA AND COGNITIVE IMPAIRMENT IN EPILEPSY PATIENTS TREATED WITH VALPROIC ACID - PRELIMINARY STUDY. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Valproate-Induced Hyperammonemic Encephalopathy in General Hospital Patients With One or More Psychiatric Disorders. [2022]

11. Denmark pubmed.ncbi.nlm.nih.gov

[Valproate can induce reversible encephalopathy]. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Add-on memantine to valproate treatment increased HDL-C in bipolar II disorder. [2022]

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

Hyperammonemia in patients receiving valproic acid in the hospital setting: A retrospective review. [2022]