Virtual Therapy for Anxiety and Mood Disorders

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Not using Teleo platform

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well children engage with virtual therapy for anxiety and mood issues. It compares a new therapy platform, Teleo, with regular video calls like Zoom. The trial aims to determine if Teleo improves therapy adherence in children. It suits children already using Teleo and diagnosed with a mental health condition. As an unphased trial, it provides a unique opportunity for children to contribute to innovative therapy research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Teleo virtual therapy platform is safe for children undergoing psychotherapy?

Research has shown that virtual therapy, such as Teleo, provides a safe way to receive mental health treatment from home. Teleo ensures privacy by adhering to strict confidentiality rules. However, specific safety guidelines for home-based therapy do not exist. Some therapists express concerns about potential issues, such as technology problems or the therapy's effectiveness for certain individuals. Despite these concerns, virtual therapy is widely used and generally effective for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Teleo because it offers a unique approach to virtual therapy for anxiety and mood disorders. Unlike traditional videoconferencing tools like Zoom, Teleo is specifically designed for therapeutic use, potentially enhancing the efficacy of virtual sessions. This specialized platform may provide a more tailored and effective therapy experience, which is why it's generating interest as a promising alternative to standard video platforms.

What evidence suggests that the Teleo virtual therapy platform is effective for anxiety and mood disorders?

Research has shown that online cognitive behavior therapy (ICBT) effectively treats anxiety and depression, leading to significant improvements. In this trial, participants will receive therapy through various virtual platforms. Teleo, a virtual therapy platform tested in this trial, aims to enhance remote therapy for children. Studies suggest that telehealth services, such as Teleo, are as effective as face-to-face therapy in reducing depression symptoms. Additionally, virtual reality therapy has improved anxiety. These findings suggest that Teleo could be a valuable tool for managing anxiety and mood disorders in young people. ^{1 2 4 6 7}

Who Is on the Research Team?

David S Hong, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children with mood or anxiety disorders who are undergoing psychotherapy. It's designed to see if a virtual therapy platform called Teleo increases engagement compared to standard videoconferencing. Families willing to participate in four therapy sessions and have their child's engagement measured can join.

Inclusion Criteria

I am between the ages of 5 and 14.

RCADS score > 65

Likely have at least 12 sessions remaining

Exclusion Criteria

Not under treatment with provider using Teleo platform

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psychotherapy through either the Teleo virtual therapy platform or standard video conferencing for 4 sessions

4 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for engagement and outcomes post-intervention

4 weeks

Post-intervention assessment (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Teleo

Trial Overview The study tests the 'Teleo' virtual therapy platform against standard videoconferencing methods over four sessions of psychotherapy. Engagement levels will be assessed using established measures, comparing how well each method keeps children involved in treatment.

How Is the Trial Designed?

Group I: Teleo Experimental Treatment 1 Intervention

Participants in this group will under therapy for 4 sessions using the Teleo virtual therapy video platform, sessions will be recorded and questionnaires and clinical data will be measured.

Group II: Standard videoconferencing Active Control 1 Intervention

Participants in this group will under therapy for 4 sessions using standard video platforms (e.g. zoom or other publicly available product), sessions will be recorded and questionnaires and clinical data will be measured.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

MainSquare Co. (dba 'Teleo')

Collaborator

Trials

1

Recruited

40+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Patients using the online telemental health platform (Brightside) showed a significantly higher rate of improvement in depression symptoms, with nearly 80% experiencing a reduction of 5 or more points on the PHQ-9 scale, compared to 52% in the treatment as usual (TAU) group.

The average reduction in PHQ-9 scores was greater for the Brightside group (-11.5) than for the TAU group (-10.1), indicating that the telemental health approach may be more effective in managing depression symptoms in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Evaluation of Measurement-Based Psychiatric Care Delivered via Specialized Telemental Health Platform Versus Treatment As Usual: A Retrospective Analysis. Chokshi, S., Senathirajah, Y., Yadav, V., et al.[2022]

Home-based telemental health (TMH) therapy for youth requires specific clinical, logistical, and safety procedures to address unique challenges, as highlighted in the Targeted Approach to Safer Use of Antipsychotics in Youth (SUAY) study involving youth ages 3-17.

Key adaptations include ensuring privacy during sessions, planning for crises, and providing technological support, which are essential for optimizing care and safety in a non-traditional therapy setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing home-based telemental health services for youth: Practices from the SUAY Study. Schoenfelder Gonzalez, E., Myers, K., Thompson, EE., et al.[2021]

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]

There is growing evidence that computer-based and online therapies (e-therapy) are effective in treating depression and anxiety in children and adolescents, supported by randomized controlled trials.

While many programs show promise, further research is needed to confirm their long-term effectiveness and to ensure that new e-therapy programs align with technological advancements for better engagement and delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Based and Online Therapy for Depression and Anxiety in Children and Adolescents. Stasiak, K., Fleming, T., Lucassen, MF., et al.[2022]

In a pilot study involving 100 patients using the Blues Begone computerized CBT program for depression and anxiety, 58 patients completed the program, showing promising engagement with the treatment.

Of those who completed the program, 72% achieved reliable improvement, and 62% experienced both reliable and clinically significant change, suggesting that Blues Begone could be an effective home-based treatment option with minimal human support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial in the NHS of Blues Begone: a new home based computerized CBT program. Purves, DG., Bennett, M., Wellman, N.[2019]

Digital media and electronic health systems can effectively assess and monitor both somatic and psychiatric disorders by collecting real-world data on symptoms, wellbeing, and physiological indicators over time.

For online interventions to be successful, patients require motivation and support from therapists, highlighting the need for mental health professionals to become proficient in using digital tools to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] Lüttke, S., Hautzinger, M., Fuhr, K.[2019]

Internet delivered cognitive behaviour therapy (ICBT) has been shown to be effective for treating anxiety and depression, with large clinical improvements and high patient satisfaction reported across clinics in Sweden, Denmark, Norway, Canada, and Australia.

ICBT services, which include therapist support and rigorous governance for quality and safety, can reach more patients, especially those in remote areas, compared to traditional face-to-face assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICBT in routine care: A descriptive analysis of successful clinics in five countries. Titov, N., Dear, B., Nielssen, O., et al.[2023]

Citations

1. med.stanford.edu med.stanford.edu/psychiatry/news/new-funding-announcement/teleo.html

Researchers at Stanford Psychiatry awarded grant to research ... Teleo is developing a HIPAA-compliant virtual therapy room for children with the goal of improving how clinicians deliver remote teletherapy to children.

2. withpower.com withpower.com/trial/phase-mood-disorders-6-2024-65f1e

Virtual Therapy for Anxiety and Mood Disorders Internet delivered cognitive behaviour therapy (ICBT) has been shown to be effective for treating anxiety and depression, with large clinical improvements and ...

3. withpower.com withpower.com/trial/phase-anxiety-disorders-8-2025-b5fec

Teleo Virtual Therapy for Anxiety Disorders It's designed to see if a virtual therapy platform called Teleo can help them more than standard videoconferencing used in psychotherapy. Inclusion Criteria.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8595951/

Comparing efficacy of telehealth to in-person mental health ... Results suggest telehealth as a viable care alternative with no significant differences between in-person and telehealth groups in depressive symptom reduction.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11904249/

Effectiveness of virtual reality therapy in the treatment ... The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

6. reporter.nih.gov reporter.nih.gov/search/f87G3bxuOEWA0P60NA-r7g/project-details/10922556

Engagement and clinical impact of the Teleo virtual therapy ... (dba “Teleo”) is developing a HIPAA-compliant virtual therapy room for children that transforms how clinicians deliver psychotherapy to children remotely, ...

7. hsrd.research.va.gov hsrd.research.va.gov/publications/esp/telehealth-mh-brief.pdf

Evidence Brief: Safety and Effectiveness of Telehealth Fewer studies were identified for other mental health conditions, including depression, anxiety- related disorders, and SUDs. No studies were ...