AI-Powered Counseling for Depression and Anxiety (SPEAC Trial)

N/A

Recruiting

Led By Jun Ma, MD, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 18 weeks

Summary

This trial studies ways to help people with mild-to-moderate depression/anxiety improve their emotional health via 8 coaching sessions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves counseling interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal issues during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Magnetic Resonance Imaging

Secondary study objectives

Change from baseline Penn State Worry Questionnaire (PSWQ) at 18 weeks

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Group 1: Lumen Coached GroupActive Control1 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 GroupActive Control1 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 GroupPlacebo Group1 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).

Do I qualify?Apply below to find out