First Randomized Controlled Trial Comparing Woebot to Clinician-Led Psychotherapy Reveals Digital Mental Health Intervention Is Non-Inferior in Reducing Depressive Symptoms Among Teens

Adolescents who talked to Woebot’s study app had reductions in symptoms of depression that were statistically indistinguishable from those experienced in clinician-delivered therapy

NEW YORK, October 26, 2023–(BUSINESS WIRE)–Woebot Health today announced positive results from a study at Children’s Hospital of The King’s Daughters (CHKD) showing that the digital mental health intervention W-GenZD, a Woebot-based study app, led to reductions in depressive symptoms that were non-inferior to those achieved by a clinician-led telehealth Cognitive Behavioral Therapy (CBT) skills group. Participants in both the W-GenZD and telehealth groups reported a significant reduction in depressive symptoms (PHQ-8) from baseline to end of treatment (week 4) and had similar levels of intervention feasibility and satisfaction. The results were presented in a poster presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) conference.

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This is the first known study to compare an agent-based digital mental health intervention to a therapist-led therapeutic intervention in a real-world clinical setting. It included multiple methods of safety monitoring of adolescents in both interventions. There were no serious adverse events in either group and no unanticipated adverse device effects in the W-GenZD group. The findings suggest a potential role for W-GenZD within outpatient mental health care clinics to address the ongoing adolescent mental health crisis.

The study was conducted by Woebot Health in collaboration with CHKD, a hospital and outpatient mental health clinic that uses a stepped care approach to triage patients depending on their presenting level of need. The 141 teen participants were actively seeking outpatient mental health services for symptoms of depression and/or anxiety and represented a mix of identities (92% non-Hispanic, 49% White, 34% African American and 60% heterosexual). The study was designed to investigate the feasibility, satisfaction and non-inferiority (for PHQ-8) of W-GenZD (n = 71) compared to a group receiving CBT skills delivered via telehealth and led by a licensed mental health clinician (n = 70).

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Importantly, both groups developed similar levels of therapeutic working alliance, meaning perceived alliance between the teen and the human group leader or between the teen and Woebot. Therapeutic alliance measures the relationship between provider and patient/participant, with research indicating that it is an important predictor of therapeutic outcomes. Previous research from Woebot Health has found that people reported formation of a therapeutic bond similar to the bond formed with human therapists in other studies.

The pandemic exacerbated a long-standing crisis of unmet pediatric mental health needs into a national state of emergency, prompting President Biden to highlight youth mental health as a priority in his 2023 State of the Union address and the Biden-Harris Administration to more recently provide more than $200 million in funding to expand youth mental health care services. Even before the skyrocketing demand for mental health services, CHKD had embarked on a major expansion of its team and services, including state-of-the-art preventive, outpatient and inpatient services in a new mental health facility.

“The unprecedented need for child mental health services, along with a national shortage of pediatric mental health providers, requires us to look for innovative approaches to provide support,” said Mary Margaret Gleason, MD, Vice Chair of Pediatrics at CHKD and Kay W. Abiouness Distinguished Professor at Eastern Virginia Medical School, and principal investigator of the study. “This study offered us a chance to examine a novel intervention that could help address adolescent anxiety and depression on their own schedule, in a familiar, digital environment. The positive findings indicate that high-quality, rigorously studied mobile health apps can be considered as part of our toolkit to address the child mental health crisis.”

One of the study participants confirmed the most helpful aspect of W-GenZD was its accessibility. “If I needed help immediately, I could get it. I think just knowing I had someone or something there to help me out reduced some of my anxiety.”

Woebot Health’s Chief Clinical Officer Athena Robinson, PhD, added, “This is a transformational time for evidence-based, technology-supported care, and it has been rewarding to work with an organization interested in evaluating new approaches to expand services for teens in need. We look forward to additional collaborations that examine and showcase technology’s potential to set a new framework for care.”

Study design and methodology

Between May 2022 and February 2023, after a clinical visit to the CHKD facilities, participants were triaged into standard outpatient mental health care and were screened and randomized to W-GenZD or a CBT Skills Group. Assessments were at baseline, 4 weeks end of treatment and 8-weeks end-of-study and included: a Patient Health Questionnaire (PHQ-8) assessing depression symptoms; a Generalized Anxiety Disorder (GAD-7) score assessing anxiety symptoms; a Working Alliance Inventory–Short Form (WAI-SR) score; a Usage Rating Profile–Intervention Revised (URP-IR) score for feasibility; and a Client Satisfaction Questionnaire (CSQ-8) satisfaction rating. A non-inferiority test was used to evaluate the study aim comparing the reduction in PHQ-8-measured depression symptoms between the two interventions at the end of treatment. Clinical trial information is available at https://clinicaltrials.gov/study/NCT05372913.

About Woebot Health

Woebot Health is the mental health ally for people and businesses that is answering the skyrocketing need for mental health care by breaking down the systemic constraints that block equal access to it. Our relational agent, Woebot, is at the heart of a powerful platform that can tailor products for specific intended uses and patient populations. It’s also the foundation of our solutions, which offer CBT-based support tools for adults, adolescents and new mothers. We work directly with virtual primary care companies, payers and IDNs to put scalable and validated mental health solutions directly in the hands of those who need them. For more information, visit woebothealth.com

W-GenZD is not evaluated, cleared or approved by the FDA. It may be considered as an adjunct to clinical care. It does not replace clinical care.

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Contacts

Margot Carlson Delogne
margot@woebothealth.com
(781) 492-1039