What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT), including its remote internet-based form (eCBT), is generally well-tolerated with minimal side effects, though some patients may experience temporary increases in anxiety or emotional discomfort. Pharmacotherapy, particularly with selective serotonin reuptake inhibitors (SSRIs), can have side effects such as nausea, insomnia, sexual dysfunction, and weight gain. Combining CBT with pharmacotherapy can be effective but may also combine the side effects of both treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and atypical antidepressants like bupropion. These medications help alleviate depressive symptoms by altering brain chemistry. In addition to pharmacotherapy, cognitive-behavioral therapy (CBT) is a widely recognized and effective treatment for depression, focusing on changing negative thought patterns and behaviors. While eCBT is a newer modality, traditional face-to-face CBT has been well-established in clinical practice. The combination of medication and CBT is often recommended for more comprehensive treatment of major depressive disorder.

What other types of research exist?

Promising, novel alternatives to Remote Internet-Based Cognitive Behavior Therapy (eCBT) for depression patients in 2024 include: 1) Electroconvulsive Therapy (ECT) - particularly for treatment-resistant depression, 2) Transcranial Magnetic Stimulation (TMS) - a non-invasive brain stimulation technique, 3) Ketamine Infusion Therapy - shown to have rapid antidepressant effects, 4) Digital Medicine Systems - integrating medication management with digital monitoring, and 5) Virtual Reality Therapy - immersive environments to practice coping strategies and reduce symptoms.

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Cognitive Behavioral Therapy

eCBT for Depression (AMHI Trial)

N/A

Recruiting

Led By Robert Bossarte, PhD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 week follow-up

Awards & highlights

AMHI Trial Summary

This trial will test whether or not providing rural primary care clinicians with access to eCBT will help improve treatment of patients with MDD.

Who is the study for?

This trial is for individuals in rural West Virginia and Kentucky who are literate in English, seeking treatment for Major Depressive Disorder (MDD) for the first time in six months, have access to a smartphone or computer, and are suitable for outpatient treatment. It excludes those with hearing, vision or cognitive impairments that affect research participation.Check my eligibility

What is being tested?

The study tests if giving primary care doctors access to remote internet-based Cognitive Behavior Therapy (eCBT) can improve MDD treatment outcomes. Participants will receive eCBT through their smart devices or computers.See study design

What are the potential side effects?

Since this intervention involves therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort during therapy sessions as they address personal issues.

AMHI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 week follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

RDQ-7

Secondary outcome measures

Compliance with Antidepressant Medication Treatment

PROMIS Short Form v1.0 - Severity of Substance Use (past 30 days)

SDM-Q-9

AMHI Trial Design

3Treatment groups

Active Control

Group I: Primary Care TreatmentActive Control1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician for MDD.

Group II: Primary care treatment with guided eCBTActive Control1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of guided eCBT for MDD.

Group III: Primary care treatment with eCBTActive Control1 Intervention

The participant will receive treatment as usual as prescribed by the primary care physician with the addition of eCBT for MDD.

Do I qualify?Apply below to find out

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

Cognitive Behavioral Therapy (CBT) and its remote variant, eCBT, work by helping patients identify and change negative thought patterns and behaviors that contribute to their depression. This therapeutic approach aims to break the cycle of negative thinking and behavior, thereby improving mood and functioning. Pharmacotherapy, often involving selective serotonin reuptake inhibitors (SSRIs), works by increasing the levels of serotonin in the brain, which can help improve mood and emotional stability. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, recognize the importance of adherence, and set realistic expectations for their recovery process.

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

177 Previous Clinical Trials

58,831 Total Patients Enrolled

3 Trials studying Depression

561 Patients Enrolled for Depression

University of South FloridaLead Sponsor

414 Previous Clinical Trials

184,937 Total Patients Enrolled

18 Trials studying Depression

5,284 Patients Enrolled for Depression

Patient-Centered Outcomes Research InstituteOTHER

555 Previous Clinical Trials

29,944,116 Total Patients Enrolled

31 Trials studying Depression

136,519 Patients Enrolled for Depression

Media Library

Remote Internet-based Cognitive Behavior Therapy (eCBT) (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04120285 — N/A

Depression Research Study Groups: Primary Care Treatment, Primary care treatment with guided eCBT, Primary care treatment with eCBT

Depression Clinical Trial 2023: Remote Internet-based Cognitive Behavior Therapy (eCBT) Highlights & Side Effects. Trial Name: NCT04120285 — N/A

Remote Internet-based Cognitive Behavior Therapy (eCBT) (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04120285 — N/A

~560 spots leftby Feb 2025

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