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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to develop and test a telehealth tool intended to support community mental health clinicians to deliver cognitive behavioral therapy (CBT). The main aims of the study are to: 1. Collaborate with clinicians and supervisors to design an accessible prototype to increase clinician use of CBT in community mental health settings through focus groups, interviews, and surveys. 2. Adapt the initial model through feedback from clinicians and their patients who will be asked to test the tool then complete interviews and surveys. 3. Test the model with clinicians and their patients who will be asked to use the tool for several weeks. 4. Evaluate the acceptability and feasibility of using the tool in a pilot trial through surveys and interviews.

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 data supports the effectiveness of the treatment Tele-BE for delivering cognitive behavioral therapy?

Research shows that internet-based cognitive behavioral therapy (iCBT) can help reduce symptoms of depression and anxiety. In one study, patients using a digital mental health program experienced a 23% reduction in depression scores. This suggests that digital tools like Tele-BE can be effective in supporting mental health treatment. ^{1 2 3 4 5}

Is Tele-BE for delivering cognitive behavioral therapy safe for humans?

Research on telemental health (TMH) services, including internet-delivered cognitive behavioral therapy, shows that while some clients may experience negative effects like technical difficulties or emotional distress, severe adverse events are rare. Safety protocols and tools have been developed to ensure safe delivery of TMH, especially in home settings, and these protocols have been effective in addressing safety concerns when they arise. ^{6 7 8 9 10}

How is the Tele-BE treatment different from other treatments for this condition?

Tele-BE is unique because it delivers cognitive behavioral therapy (CBT) through the internet, allowing patients to receive therapy remotely. This approach makes therapy more accessible and can be as effective as traditional in-person CBT, especially for conditions like depression, social anxiety, and panic disorder. ^{11 12 13 14 15}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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-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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Blending online therapy into regular face-to-face therapy for depression: content, ratio and preconditions according to patients and therapists using a Delphi study. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Blended Care-Cognitive Behavioral Therapy for Depression and Anxiety in Real-World Settings: Pragmatic Retrospective Study. [2020]

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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

Working alliance in low-intensity internet-based cognitive behavioral therapy for depression in primary care in Spain: A qualitative study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Home-Based Telemental Health: A Proposed Privacy and Safety Protocol and Tool. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. [2020]

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

Home-based telemental healthcare safety planning: what you need to know. [2012]

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

Safety of telemental healthcare delivered to clinically unsupervised settings: a systematic review. [2018]

11. Finland pubmed.ncbi.nlm.nih.gov

[Internet-based cognitive-behavioral therapy in the treatment of psychiatric disorders]. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Feasibility of a traditional and teletreatment approach to mirror therapy in patients with phantom limb pain: a process evaluation performed alongside a randomized controlled trial. [2022]

13. England 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. [2023]

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

An Internet-based self-help treatment for fear of public speaking: a controlled trial. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavior therapy for depression, social anxiety disorder, and panic disorder: Effectiveness and predictors of response in a teaching clinic. [2021]