AI-Powered Counseling for Depression and Anxiety

(SPEAC Trial)

No longer recruiting at 1 trial location

Overseen By Jun Ma, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antidepressants, Antianxiety

Disqualifiers: Bipolar, Psychotic disorder, Severe medical, others

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how coaching, either from an AI-powered virtual coach or a human coach, can improve emotional health in individuals with untreated mild-to-moderate depression and anxiety. Participants will be divided into three groups to receive problem-solving skills training through an AI coach, a human coach, or a delayed option for the AI coach. Ideal participants are those experiencing significant emotional distress from depression or anxiety but have not yet sought treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emotional health strategies for many.

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

Yes, you must not be on current pharmacotherapy for depression or anxiety to join the trial. However, if you start taking medications after joining, you won't be withdrawn from the study.

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

The trial requires that participants do not currently take medications for depression or anxiety. However, if you start taking these medications after joining, you won't be removed from the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that problem-solving treatment (PST) is generally safe for people with depression and anxiety. The Lumen Coached PST program uses a virtual voice-based coach to guide participants. Early studies with Lumen have shown promising results in improving thinking and emotional well-being without serious side effects. Participants found it helpful in managing daily challenges.

The Human Coached PST is also a well-known method. It has been used successfully to treat depression and anxiety, with no major safety concerns reported. This method involves working directly with a trained human coach, which many people find supportive and effective.

Both approaches focus on teaching problem-solving skills, which can help improve emotional well-being. While no treatment is completely risk-free, these methods are generally well-tolerated, with few negative effects reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they harness the power of technology to address depression and anxiety in innovative ways. The Lumen Coached PST Intervention uses AI-driven counseling through a digital coach named Lumen, providing a unique and accessible way to learn problem-solving skills at home. This approach can offer a personalized experience with the convenience of automated reminders and flexible scheduling through a study iPad. On the other hand, the Human Coached PST Intervention combines traditional in-person sessions with remote follow-ups via Zoom, blending the familiarity of human interaction with the convenience of technology. Both methods aim to make mental health support more adaptable and accessible compared to standard therapies, which often require regular in-person visits.

What evidence suggests that this trial's treatments could be effective for depression and anxiety?

Research has shown that both Lumen Coached Problem-Solving Treatment (PST) and Human Coached PST, studied in this trial, effectively reduce symptoms of depression and anxiety. Participants may receive the Lumen AI coach, which studies have found significantly improves mood and mental control, as measured by brain scans and symptom checklists. Alternatively, participants may receive Human Coached PST, a proven and trusted treatment for these conditions, which has long been a standard method for managing depression and anxiety. Both methods in this trial teach problem-solving skills to help with daily challenges affecting emotional health. ^{1 2 3 4 6}

Who Is on the Research Team?

Jun Ma, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Adults with mild-to-moderate, untreated depression or anxiety can join. They must score within certain ranges on the PHQ-9 and GAD-7 scales, be over 18 years old, and able to give informed consent in English. Exclusions include severe medical conditions, brain injuries or abnormalities, current heavy treatments for cancer, pregnancy or recent childbirth, other clinical trials participation that could interfere with this study's results.

Inclusion Criteria

Emotional distress defined by elevated depressive (PHQ-9 scores 10-19) and/or anxious symptoms (GAD-7 scores 10-14)

Willing and able to provide informed eConsent and HIPAA authorization

Exclusion Criteria

Unable to speak, read, or understand English for informed consent

I weigh 325 pounds or more.

I was diagnosed with cancer, other than non-melanoma skin cancer, in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Orientation

Participants attend an orientation session to receive training and materials for the PST program

1 week

1 visit (in-person)

Treatment

Participants complete 8 PST sessions over 12 weeks, either with Coach Lumen or a human coach

12 weeks

8 sessions (4 weekly, 4 biweekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 18 weeks

18 weeks

2 visits (in-person)

Optional Extension

Participants in the delayed Lumen Coached Group can choose to start PST sessions after the 18-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Human Coached PST Intervention
• Lumen Coached PST Intervention
• Optional (delayed) Lumen Coached PST (Waitlist control)

Trial Overview

The trial is testing a virtual voice-based coach called Lumen against human coaches to deliver Problem-Solving Treatment (PST) via an iPad or videoconference/phone. Participants will learn problem-solving skills over eight sessions to help manage daily problems contributing to their emotional distress.

How Is the Trial Designed?

Group I: Group 1: Lumen Coached Group Active Control 1 Intervention

Participants in this group will attend an Intervention Orientation session to receive the Coach Lumen tutorial, a study iPad, and a Lumen Intervention Workbook. They will complete 8 PST sessions with Coach Lumen using their study assigned iPad at home over 12 weeks. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminders on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions through the iPad. Participants will work with Coach Lumen to learn problem-solving skills to address current life challenges, plan activities, and complete home activities. Participants will also complete surveys before and after each PST session: a mood assessment survey before and a user experience survey after. At the end of study, Participants may be invited to provide their perspective regarding their Lumen use experience.

Group II: Group 2: Human Coached Group Active Control 1 Intervention

Participants in this group will receive a study iPad and Human-Coached Intervention Workbook and will complete the first of 8 PST sessions in person with a trained health coach. Participants' first PST session will be in person for approximately 1 hour. Participants will complete the remaining sessions remotely via Zoom (or by phone, if necessary) using their study iPad. The first 4 sessions occur weekly and then the last 4 occur every other week. Participants will receive automated reminder notifications on the day before and on the day of their scheduled session, and have the opportunity to reschedule sessions with their coach. Participants will also complete a mood assessment survey at the beginning of each PST session. Participants will work with their health coach to learn problem-solving skills to address current life challenges, plan activities, and complete home activities.

Group III: Group 3: Optional (Delayed) Lumen Coached Group Placebo Group 1 Intervention

Participants assigned to this group can choose to attend a Lumen Orientation session to receive training and a study iPad to complete 8 PST sessions with Coach Lumen after their follow-up assessment at 18 weeks. They will receive 8 Sunday mood assessment surveys to complete (4 every Sunday and then 4 every other Sunday).

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Chatbots can effectively support patients with anxiety and depression, serving as affordable and efficient virtual assistants, especially in areas with limited mental health resources.

Out of 42 studies reviewed, about 60% of chatbots targeted both anxiety and depression, indicating their versatility in addressing multiple mental health issues, while their role in mental health care is expected to grow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chatbot features for anxiety and depression: A scoping review. Ahmed, A., Hassan, A., Aziz, S., et al.[2023]

Project AFFECT aims to create an AI-based software, LyssnCBT, to automatically assess the quality of cognitive behavioral therapy (CBT) sessions, which could enhance training and supervision for therapists and improve treatment outcomes for clients.

In a planned Phase II trial involving 1,875 clients, the effectiveness of LyssnCBT will be evaluated to see if it can improve therapist skills, client outcomes, and reduce client drop-out rates, marking a significant step towards scalable quality assurance in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the quality of cognitive behavioral therapy in community mental health through artificial intelligence generated fidelity feedback (Project AFFECT): a study protocol. Creed, TA., Salama, L., Slevin, R., et al.[2023]

A computer-aided self-help clinic effectively increased the number of anxious and depressed patients treated per clinician while reducing the time each patient spent with a clinician, without compromising treatment effectiveness.

Patients showed improvement using one of four computer-aided cognitive behavior therapy (CBT) systems for various anxiety and mood disorders, highlighting the potential for these systems to enhance accessibility and reduce stigma associated with mental health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided CBT self-help for anxiety and depressive disorders: experience of a London clinic and future directions. Gega, L., Marks, I., Mataix-Cols, D.[2022]

The implementation of the ItFits-toolkit in the online clinic improved the intake procedure for therapists, providing them with more relevant patient information and leading to better alignment of expectations between patients and therapists.

Therapists reported that the new automated screening process resulted in a better fit of patients for treatment, increased patient inclusion in the program, and overall satisfaction, indicating that the ItFits-toolkit effectively enhanced the delivery of guided internet-based cognitive behavioral therapy (iCBT) for anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist perceptions of the implementation of a new screening procedure using the ItFits-toolkit in an iCBT routine care clinic: A mixed-methods study using the consolidated framework for implementation research. Tarp, K., Nielsen, SL., Holmberg, TT., et al.[2023]

An automated feedback system using machine learning and speech processing technologies was developed to provide therapists with real-time quality metrics on their motivational interviewing skills, making the feedback process more efficient and scalable.

In a study with 21 therapists, the majority found the system easy to use and reported that the feedback aligned with their self-assessment, indicating strong potential for integrating this technology into regular psychotherapy training and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design feasibility of an automated, machine-learning based feedback system for motivational interviewing. Imel, ZE., Pace, BT., Soma, CS., et al.[2022]

This study will evaluate the effectiveness of an innovative internet-based cognitive behavioral therapy (iCBT) program enhanced by artificial intelligence (AI) technologies to improve depression among 1400 healthy workers during the COVID-19 pandemic.

The program, called SMART-CBT, consists of a 6-week course with machine-guided exercises and aims to provide a cost-effective mental health solution that can be widely disseminated, marking the first randomized controlled trial of its kind.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial. Kawakami, N., Imamura, K., Watanabe, K., et al.[2021]

In a study involving 1,205 users of the Wysa app for mental health, users reported a strong therapeutic alliance with the AI conversational agent, with scores comparable to traditional therapy methods like CBT.

Over a brief period of 3 days, users' perceptions of their bond with Wysa improved, indicating that digital mental health services can effectively foster a therapeutic relationship similar to that found in face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Therapeutic Alliance With a Free-Text CBT Conversational Agent (Wysa): A Mixed-Methods Study. Beatty, C., Malik, T., Meheli, S., et al.[2022]

The ePST™ program, a stand-alone multimedia interactive treatment for depression, was well-received by participants, who found it highly usable, acceptable, and credible, with a therapeutic alliance comparable to live therapy.

Among the 29 participants, those who completed at least 4 sessions showed significant improvement in depressive symptoms over the 10-week study, suggesting that ePST™ may be an effective treatment option for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. Berman, MI., Buckey, JC., Hull, JG., et al.[2021]

A systematic review of 10 studies found that using artificial intelligence (AI), particularly conversational AI agents like chatbots, can significantly enhance psychotherapy outcomes and reduce symptoms in patients with emotional disorders.

Patients reported high satisfaction and engagement when AI was integrated into therapy, suggesting that AI can make psychological interventions more personalized and effective, although further robust research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Artificial Intelligence to Enhance Ongoing Psychological Interventions for Emotional Problems in Real- or Close to Real-Time: A Systematic Review. Gual-Montolio, P., Jaén, I., Martínez-Borba, V., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05603923

NCT05603923 | Study of a PST-Trained Voice-Enabled ...

Participants in the human coached PST arm will serve as active treatment controls given the demonstrated efficacy of human coached PST in depression and anxiety ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714424001575

Study of a PST-trained voice-enabled artificial intelligence ...

Participants in the human-coached PST group will serve as an active treatment comparison given the demonstrated efficacy of human-coached PST in depression and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10175049/

Effects of a virtual voice-based coach delivering problem ...

Lumen intervention also led to decreased HADS depression, anxiety, and overall psychological distress scores, with medium effect sizes (Cohen's d = 0.49, 0.51, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10660207/

Association Between User Interaction and Treatment ...

The pilot RCT demonstrated decreased depression and anxiety symptoms in the Lumen intervention group compared with the control group [19]. This ...

5.

withpower.com

withpower.com/trial/phase-depression-2023-5fa48

AI-Powered Counseling for Depression and Anxiety · Info ...

Is the treatment 'Human Coached PST Intervention, Lumen Coached PST Intervention' a promising treatment for depression and anxiety? Yes, the treatment is ...

6.

humanfactors.jmir.org

humanfactors.jmir.org/2023/1/e49715/

Association Between User Interaction and Treatment ...

This study evaluated the relationships between objective and subjective user interaction measures as well as treatment response on Lumen, a novel voice-based ...