What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT), including its internet-based variant like Empower@Home, works by helping patients identify and change negative thought patterns and behaviors that contribute to their depression. This therapeutic approach aims to improve emotional regulation and develop personal coping strategies. Pharmacotherapy, often involving antidepressants, works by altering brain chemistry to improve mood and emotional state. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, set realistic expectations, and actively engage in their recovery process.

What side effects are associated with this type of intervention?

Internet-based Cognitive Behavioral Therapy (CBT) for depression is generally well-tolerated with minimal side effects. Unlike pharmacological treatments, CBT does not have physical side effects such as nausea, weight gain, or sexual dysfunction. However, some individuals may experience temporary emotional discomfort as they confront challenging thoughts and feelings during therapy. Additionally, there may be issues related to the digital format, such as technical difficulties or reduced personal interaction compared to face-to-face therapy. Overall, the side effects are relatively minor and manageable.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. While the FDA has not specifically approved internet-based Cognitive Behavioral Therapy (CBT) for depression, CBT itself is a well-established, evidence-based treatment for depression. The Empower@Home trial is exploring the effectiveness of an internet-based CBT program, which aligns with the broader trend of utilizing digital health interventions to increase accessibility and convenience for patients.

What other types of research exist?

Promising alternatives to Empower@Home for treating depression in 2024 include: 1) Mobile phone-based interventions, which have shown effectiveness in smoking cessation and could be adapted for depression treatment. 2) Digital CBT-I (Cognitive Behavioral Therapy for Insomnia), which has demonstrated improvements in psychological well-being and could be tailored for depression. 3) Smartphone-assisted self-help programs, which have been effective for binge eating disorder and could be repurposed for depression. These alternatives leverage technology to provide accessible and effective mental health support.

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Cognitive Behavioral Therapy

Internet Cognitive Behavioral Therapy for Depression

N/A

Waitlist Available

Led By Xiaoling Xiang, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

have at least mild depressive symptoms, based on PHQ-9 >=5

≥50 years

Must not have

Have severe vision impairment that can not be corrected and with no in-home help to assist them with using a mobile device

They do not speak English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline phq-9 at 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online therapy program called Empower@Home for older adults with high levels of depression. The program includes online sessions and coaching calls to help participants change negative thoughts and behaviors. It aims to make therapy more accessible for homebound seniors.

Who is the study for?

This trial is for Michigan residents over 50 with mild depression, as indicated by a PHQ-9 score of at least 5. It's not suitable for those with active suicidal thoughts, terminal illness, severe vision impairment without help, probable cognitive impairment, non-English speakers, or recent substance abuse issues.

What is being tested?

The study tests Empower@Home—an internet-based cognitive behavioral therapy program designed to reduce depressive symptoms in older adults. The intervention lasts about 10 weeks and aims to demonstrate improved mood post-treatment.

What are the potential side effects?

Since this is a psychological therapy program delivered online, there are no direct medical side effects like you'd expect from medication; however, participants may experience emotional discomfort addressing mental health issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

I experience mild or more severe depression symptoms.

Select...

I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe vision problems and no one to help me use a mobile device.

Select...

I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline phq-9 at 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline phq-9 at 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline phq-9 at 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Patient Health Questionnaire-9 (PHQ-9)

Modified Treatment Evaluation Inventory

Secondary study objectives

Change in Duke Social Support Index (DSSI)-10

Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)

Change in PROMISE-SI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Internet-based programExperimental Treatment1 Intervention

Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empower@Home

2022

N/A

~320

0 / 4Eligibility 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

Cognitive Behavioral Therapy (CBT), including its internet-based variant like Empower@Home, works by helping patients identify and change negative thought patterns and behaviors that contribute to their depression. This therapeutic approach aims to improve emotional regulation and develop personal coping strategies. Pharmacotherapy, often involving antidepressants, works by altering brain chemistry to improve mood and emotional state. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, set realistic expectations, and actively engage in their recovery process.

The effectiveness of psychosocial modalities in the treatment of alcohol problems in adults: a review of the evidence.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.Addressing the challenges of a cross-national investigation: lessons from the Pittsburgh-Pisa study of treatment-relevant phenotypes of unipolar depression.