What side effects are associated with this type of intervention?

Common treatments for mental disorders include pharmacological options such as antidepressants and antipsychotics, and telehealth interventions. Antidepressants, including SSRIs and SNRIs, can cause side effects like nausea, weight gain, sexual dysfunction, and insomnia. Antipsychotics may lead to weight gain, diabetes, and extrapyramidal symptoms such as tremors and rigidity. Telehealth interventions, while generally safe, may face challenges like technical issues, privacy concerns, and difficulty in establishing a patient-clinician connection. These side effects should be discussed with a healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

The FDA has approved various medications for the treatment of mental disorders, including antipsychotics like risperidone, olanzapine, and aripiprazole for schizophrenia and bipolar disorder. Antidepressants such as SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., venlafaxine) are also approved for depression and anxiety disorders. The Medherent platform's focus on telehealth care-coordination services aims to enhance adherence to these medications, addressing common issues in SMI populations such as poor clinical outcomes and high hospitalization rates. Telehealth interventions have gained traction, especially during the COVID-19 pandemic, highlighting the need for effective remote management of chronic mental health conditions.

What other types of research exist?

Promising alternatives to the Medherent platform for 2024 include: 1) Pear Therapeutics' reSET and reSET-O, which are FDA-approved digital therapeutics for substance use disorders; 2) Woebot Health, an AI-driven mental health chatbot that provides cognitive behavioral therapy and mood tracking; 3) Talkspace, an online therapy platform offering access to licensed therapists via text, video, and audio messaging; 4) Quartet Health, a platform that connects patients with mental health providers and coordinates care with primary care physicians; and 5) Brightside Health, which offers evidence-based therapy and medication management for depression and anxiety through telehealth services.

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Telehealth Care-Coordination for Mental Illness (BHH Trial)

N/A

Recruiting

Led By George Unick

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed psychiatric medications

Aged 18 to 80 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years prior to study enrollment to at least one year after study enrollment.

Awards & highlights

BHH Trial Summary

This trial will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies.

Who is the study for?

This trial is for adults aged 18-80 with Serious Mental Illness (SMI) who are prescribed psychiatric medications and receive services from a participating community mental health agency. They must be willing to have the Medherent device in their residence, either as current users or new participants.Check my eligibility

What is being tested?

The study tests the Medherent medication management platform along with additional telehealth care-coordination services aimed at improving health outcomes for individuals with SMI living in community settings.See study design

What are the potential side effects?

Since this trial involves a telehealth service rather than a drug, traditional side effects aren't expected. However, there may be challenges like adapting to technology use and privacy concerns.

BHH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking medication for a mental health condition.

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I am between 18 and 80 years old.

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I am unable to understand and consent to the study.

BHH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years prior to study enrollment to at least one year after study enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years prior to study enrollment to at least one year after study enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years prior to study enrollment to at least one year after study enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Health Service Costs

Consumer Satisfaction STAR-P

Diabetes control as reported hemoglobin A1c levels

+3 more

BHH Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: New MedherentExperimental Treatment1 Intervention

Group using Medherent Device with added interventional components.

Group II: Usual CareActive Control1 Intervention

Usual Care: no intervention elements.

Group III: Existing MedherentActive Control1 Intervention

Group using the Medherent Device with no added intervention components.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mental disorders include pharmacological interventions and telehealth services. Medications like antipsychotics, antidepressants, and mood stabilizers work by adjusting neurotransmitter levels in the brain to stabilize mood, reduce psychotic symptoms, and alleviate depression. Telehealth interventions, such as those studied in the Medherent platform, enhance medication adherence and health outcomes by providing remote access to healthcare services, continuous monitoring, and timely interventions. This approach is crucial for patients with serious mental illnesses who face barriers to in-person care, offering a more flexible and accessible way to manage their conditions and improve overall health outcomes.

Emerging Needs and Viability of Telepsychiatry During and Post COVID-19 Era: A Literature Review.Collaborative Care for Psychiatric Disorders in Older Adults: A Systematic Review.