Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings

Stanford University

Status: Not yet enrolling

Conditions: Mood Disorders; Anxiety

Treatments: Other: Standard Videoconferencing; Other: Teleo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07155707

80119

R42MH136878 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This Phase II trial will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the trial will examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Full description

This study aims to examine the impact of tailored telehealth psychotherapy environments on clinical outcomes in the context of pediatric mental health treatment. Researchers will conduct a full-scale RCT with 156 families to assess how Teleo compares to standard video conferencing (e.g., Zoom) on a range of clinical metrics, including cancellation/no-show rates, clinician satisfaction, duration of treatment, need for medication, and symptoms of anxiety and depression.

Enrollment: 156 estimated patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with a mood and/or anxiety disorder
• Have proficiency to participate in psychotherapy in English
• Scheduled to begin therapy at one of the study sites
• RCADS score > 65

Exclusion criteria

- Comorbid diagnosis of intellectual disability, autism spectrum disorder, psychotic disorders, high-risk suicidal behaviors requiring immediate hospitalization, substance use disorders, or other physical or mental condition that would prohibit them from engaging in telehealth settings.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Teleo

Experimental group

Description:

Participants in this arm will undergo therapy for 12 sessions using the Teleo virtual therapy video platform. Sessions will be recorded and questionnaires and clinical data will be measured.

Treatment:

Other: Teleo

Standard Videoconferencing

Active Comparator group

Description:

Participants in this group will undergo therapy for 12 sessions using standard video platforms (e.g. Zoom or Microsoft Teams). Sessions will be recorded and questionnaires and clinical data will be measured.

Treatment:

Other: Standard Videoconferencing