Tele-BE for Delivering Cognitive Behavioral Therapy

(BENEFITS Trial)

Overseen By Megan Brady, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Imminent suicide risk, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is developing and testing a new online tool called Tele-BE to help mental health therapists deliver cognitive behavioral therapy (CBT) more effectively through telehealth. The aim is to simplify CBT use for therapists by collaborating with them to design and refine the tool. The study involves therapists and patients using the tool and providing feedback on its usefulness. It suits patients aged 14 and older who have had at least one telehealth therapy session and possess a computer or smartphone for online therapy. As an unphased trial, this study allows patients to contribute to the development of innovative therapy tools that could enhance future telehealth experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a telehealth tool for therapy, so it's likely you can continue your medications, but you should confirm with the trial coordinators.

What prior data suggests that this telehealth tool is safe for delivering cognitive behavioral therapy?

Research has shown that telehealth tools for cognitive behavioral therapy (CBT) are generally safe for patients. Studies have found that mental health treatments delivered through telehealth match the effectiveness and safety of in-person sessions. The Tele-BE platform helps therapists provide CBT more effectively during online sessions.

Evidence suggests that platforms like Tele-BE make remote therapy more accessible without adding significant risks. The system ensures secure communication and keeps records safe, which is crucial for patient safety. So far, no major reports of negative effects have emerged from using telehealth for CBT, indicating that the treatment is well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-BE because it enhances traditional cognitive behavioral therapy (CBT) by integrating a digital platform specifically for telehealth services. This allows for more consistent and potentially broader access to therapy, especially for patients who might struggle to attend in-person sessions. Unlike standard CBT, which relies heavily on face-to-face interactions, Tele-BE supports remote delivery, making therapy more flexible and accessible. By leveraging technology, Tele-BE aims to maintain the effectiveness of CBT while reaching a wider audience more conveniently.

What evidence suggests that the Tele-BE tool is effective for delivering cognitive behavioral therapy?

Studies have shown that the Tele-BE platform, which participants in this trial may receive, greatly improves the delivery of cognitive behavioral therapy (CBT) by helping therapists use CBT techniques more effectively. Specifically, patients using a similar online CBT program experienced a 23% reduction in depression and a 26% reduction in anxiety. This suggests that Tele-BE could enable therapists to provide better therapy sessions. Additionally, online CBT has successfully treated various mental health issues, such as eating disorders, by easing symptoms and increasing treatment accessibility. Overall, the evidence supports Tele-BE's potential to enhance CBT's effectiveness in online settings. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking mental health clinicians and their patients in Philadelphia. Clinicians must provide telehealth services, be trained in CBT through the Penn Collaborative, have completed a specific workshop, and have internet access. Patients must be 14+, able to consent or have a guardian who can.

Inclusion Criteria

Pilot randomized controlled trial phase - Clinician Participants: Clinician is an outpatient mental health clinician in the City of Philadelphia trained in transdiagnostic CBT through the Penn Collaborative for CBT and Implementation Science, has completed the 22-hour intensive CBT workshop through the BCI, is a practicing mental health clinician in the Philadelphia region in one of our partner local community agencies delivering telehealth services, has at least 2 clients on their caseload over the age of 14 with whom they are delivering telehealth services, is proficient in English language, and has access to a computer with internet connectivity

Prototyping open trial phase - Clinician Participants: Clinician is an outpatient mental health clinician in the City of Philadelphia trained in transdiagnostic CBT through the Penn Collaborative for CBT and Implementation Science, has completed the 22-hour intensive CBT workshop through the BCI, provides direct mental health services to a treatment-seeking population via telehealth, is proficient in English language, and has access to a computer with internet connectivity

Exclusion Criteria

My sex, background, or experience won't exclude me from this trial.

Pilot randomized controlled trial phase - Patient Participants: Patients will be excluded if they are unable to adequately consent to study procedures. For example, clients may be excluded if they are at imminent risk for suicide or homicide requiring hospitalization or are experiencing any cognitive impairment that prevents them from participating in therapy on the day their session is to be recorded, youth under the age of 18 will be excluded if they do not have an available legal guardian who is able to provide consent for their study participation (e.g., the state has legal custody of the youth), patients under the age of 14 will be excluded

I can give my consent and am not at immediate risk of harming myself or others.

Timeline for a Trial Participant

Development and Refinement

Participants collaborate to design and refine the Tele-BE prototype through focus groups, interviews, and surveys.

4-5 weeks

Multiple visits (virtual)

Field Testing

Field test and iteratively refine Tele-BE using rapid cycle prototyping with community clinicians and their patients.

4-5 weeks

Multiple visits (virtual)

Pilot Trial

Conduct a 12-week open trial to test the preliminary effectiveness of the refined Tele-BE platform.

12 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for acceptability and feasibility of Tele-BE from patient and clinician perspectives.

4 weeks

Interviews and surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Tele-BE

Trial Overview The study is testing 'Tele-BE', a telehealth tool designed to help clinicians better deliver cognitive behavioral therapy (CBT). It involves designing the prototype with clinician input, adapting it via feedback from users, then evaluating its use over several weeks.

How Is the Trial Designed?

Group I: Tele-BE Experimental Treatment 1 Intervention

Clinicians will deliver cognitive behavioral therapy as usual, as consistent with routine clinic practices, with the support of the Tele-BE platform, to patients receiving telehealth services

Group II: Treatment as usual Active Control 1 Intervention

Clinicians will deliver cognitive behavioral therapy as usual, as consistent with routine clinic practices, to patients receiving telehealth services

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The 'Talk to Me' Internet-based telepsychology program effectively treats fear of public speaking, showing equal efficacy whether self-administered or therapist-applied, based on a study with 127 participants.

Both treatment conditions significantly outperformed a waiting-list control group, and the benefits were maintained even after one year, highlighting the potential of Internet-delivered cognitive-behavioral therapy (CBT) to reach more individuals in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based self-help treatment for fear of public speaking: a controlled trial. Botella, C., Gallego, MJ., Garcia-Palacios, A., et al.[2019]

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]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

The INTERACT trial is evaluating a novel integrated online cognitive behavioral therapy (CBT) that combines live therapist-led sessions with online resources, aiming to improve adherence and effectiveness in treating depression among 434 participants from primary care settings.

This integrated approach, which includes nine live sessions and additional online materials, could potentially enhance access to effective depression treatment and may be introduced into existing psychological services if proven clinically and cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial. Tallon, D., Thomas, L., Brabyn, S., et al.[2023]

In a study of 96 clients undergoing internet-delivered cognitive behaviour therapy (ICBT), 61.5% reported experiencing at least one negative effect during treatment, highlighting the importance of monitoring these effects in real-time rather than relying solely on post-treatment reports.

Common negative effects included technical difficulties and negative emotional states, but serious adverse events like symptom deterioration were not reported, suggesting that while ICBT is generally effective, there are still challenges that need to be addressed to improve client experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. Gullickson, KM., Hadjistavropoulos, HD., Dear, BF., et al.[2020]

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]

Internet-based cognitive-behavioral therapy (CBT) is an effective self-help program that allows patients to receive psychological support via the Internet, making therapy more accessible, especially for those unable to attend traditional sessions.

This form of therapy has shown particular effectiveness in treating conditions like panic disorder, social phobia, and depression, indicating its potential to reach and help a wider range of individuals in need of mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. Holmberg, N., Kähkönen, S.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40966682/

Behavioral Nudges to Enhance Fidelity in Telehealth ... Objective: We will develop and evaluate "Tele-BE," a novel telehealth platform designed to nudge and incentivize clinicians to use core ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06601062

Leveraging Telepsychology and Behavioral Economics to ... The goal of this study is to develop and test a telehealth tool intended to support community mental health clinicians to deliver cognitive behavioral ...

3. withpower.com withpower.com/trial/phase-implementation-science-2025-4ee31

Tele-BE for Delivering Cognitive Behavioral Therapy ... Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in ...

4. researchprotocols.org researchprotocols.org/2025/1/e76035/PDF

Behavioral Nudges to Enhance Fidelity in Telehealth ... Test the preliminary effectiveness of Tele-BE versus telehealth as usual in engaging target mechanisms and enhancing clinician fidelity to CBT ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.04.07.25325397v1.full-text

Treatment Outcome of Adults Receiving Virtual Cognitive ... This study shows that virtually-delivered CBT-E effectively treats eating disorders by improving symptoms and accessibility to treatment.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK586283/

Evidence Brief: Safety and Effectiveness of Telehealth ... - NCBI Available evidence on the safety and effectiveness of telehealth-delivered mental health treatment compared with in-person delivery of the same treatment is ...

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201700477

Using Telehealth to Implement Cognitive-Behavioral Therapy The platform serves as a protected electronic record for session notes and supports secure electronic communication among the clinical team and ...

8. researchprotocols.org researchprotocols.org/2025/1/e76035

Behavioral Nudges to Enhance Fidelity in Telehealth ... Tele-BE is intended solely to support fidelity to the structural elements of CBT that should be present in sessions, regardless of where a ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722915000231

Cognitive Behavioral Therapy Using Televideo We provide a literature review of CBT over televideo across diagnoses. · We examine ethical practice in using televideo. · Televideo delivery addresses access ...