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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Teleo for anxiety and mood disorders?

Research shows that internet-based treatments, including those guided by therapists, are effective for anxiety and mood disorders, often matching the effectiveness of face-to-face therapy. These treatments have been shown to lead to significant improvements and high patient satisfaction in various studies. ^{1 2 3 4 5}

Is virtual therapy for anxiety and mood disorders safe for humans?

There are no specific safety guidelines for home-based virtual therapy, but therapists have expressed concerns about risks with certain clients, technology issues, and privacy. However, virtual therapy has been shown to reduce barriers and improve access to mental health care. ^{6 7 8 9 10}

How is the treatment Teleo for anxiety and mood disorders different from other treatments?

Teleo is a virtual therapy that uses technology to provide treatment for anxiety and mood disorders, offering increased access to care and reducing the stigma of visiting mental health clinics. Unlike traditional face-to-face therapy, it can be accessed from home, making it more convenient and potentially more effective for those with social anxiety or mobility issues. ^{1 11 12 13 14}

Research Team

David S Hong, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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2. Italy pubmed.ncbi.nlm.nih.gov

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ICBT in routine care: A descriptive analysis of successful clinics in five countries. [2023]

5. Switzerland 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Advantages and disadvantages of online and blended therapy: Replication and extension of findings on psychotherapists' appraisals. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Developing home-based telemental health services for youth: Practices from the SUAY Study. [2021]

8. United States 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. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

The therapeutic relationship in e-therapy for mental health: a systematic review. [2022]

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Therapist perspectives on telehealth-based virtual reality exposure therapy. [2023]

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Telemental health: A status update. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

An open trial in the NHS of Blues Begone: a new home based computerized CBT program. [2019]

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[E-Health in diagnosis and therapy of mental disorders : Will therapists soon become superfluous?] [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Computer-Based and Online Therapy for Depression and Anxiety in Children and Adolescents. [2022]