What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT) works by helping patients identify and change negative thought patterns and behaviors that contribute to their depression. It involves techniques such as cognitive restructuring, which challenges and modifies unhelpful thoughts, and behavioral activation, which encourages engagement in positive activities. Understanding these mechanisms is crucial for depression patients because it empowers them to actively participate in their treatment, leading to better management of symptoms and improved overall outcomes. Additionally, knowing how CBT works can help patients set realistic expectations and stay motivated throughout the therapy process.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is generally considered safe with minimal side effects. Some patients may experience temporary discomfort or emotional distress as they confront and work through difficult thoughts and feelings. Internet-based CBT (iCBT) shares similar side effects, with the added potential for technical issues or reduced personal interaction. Pharmacotherapy, often used alongside CBT, can have side effects depending on the specific medication. Common side effects of antidepressants include nausea, weight gain, fatigue, insomnia, dry mouth, blurred vision, and sexual dysfunction. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate them effectively.

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. Cognitive Behavioral Therapy (CBT), although not requiring FDA approval as it is a form of psychotherapy, is a widely recognized and effective treatment for depression. CBT focuses on changing negative thought patterns and behaviors and has been shown to be highly effective, particularly in combination with pharmacotherapy. The Mom-Net trial specifically studies an internet-based CBT program for maternal depression, highlighting the adaptability and effectiveness of CBT in various formats.

What other types of research exist?

Promising novel alternatives to Mom-Net for depression patients in 2024 include: 1) Digital Cognitive Behavioral Therapy (CBT) platforms with enhanced features such as AI-driven personalization and real-time feedback, 2) Transcranial Magnetic Stimulation (TMS) which has shown efficacy in treatment-resistant depression, 3) Mindfulness-Based Cognitive Therapy (MBCT) which integrates mindfulness practices with cognitive therapy, 4) Ketamine and Esketamine treatments which offer rapid relief for severe depression, and 5) Integrative approaches combining psychotherapy with lifestyle interventions such as exercise and dietary modifications.

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Behavioural Intervention

Cognitive Behavioral Therapy for Depression

N/A

Recruiting

Led By Lisa B Sheeber, Ph.D.

Research Sponsored by Oregon Research Institute

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of implementation in year 2

Awards & highlights

Summary

This trial tests Mom-Net, an online program with live coaching, aimed at helping low-income women of childbearing age who are at risk for depression. The program teaches new ways of thinking and behaving to reduce depression, with guidance from a coach. Internet-based cognitive behavioral therapy (CBT) has been shown to be effective in treating depression and is a promising alternative to face-to-face therapy.

Who is the study for?

This trial is for low-income mothers with depression who have a child aged 3-5 enrolled in Head Start. They must show signs of depression (score at or above 10 on the Patient Health Questionnaire) and be able to communicate in English or Spanish.

What is being tested?

The study tests Mom-Net, an online cognitive behavioral therapy program with coaching, against usual care/waitlist. It examines if Head Start can successfully deliver this program and whether it effectively reduces maternal depression and improves parenting and child behavior.

What are the potential side effects?

As Mom-Net is a non-medical intervention focusing on cognitive behavioral therapy, there are no direct medical side effects. However, participants may experience emotional discomfort addressing mental health issues during the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of implementation in year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of implementation in year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of implementation in year 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Implementation Reach (IReach)

Maternal Acceptability (Modified System Usability Scale)

Maternal Engagement (Engage)

+2 more

Secondary study objectives

5-item World Health Organization Well-Being Index

Aggressive Interpersonal Behavior (Duration)

Aggressive Interpersonal Behavior (Proportion)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mom-NetExperimental Treatment1 Intervention

Mom-Net is a guided Internet intervention. Mom-Net is distinct from other CBT interventions for depression in addressing the link between maternal depression and parenting. Mom-Net's content includes core CBT skills taught in ways that are relevant to one's parenting interactions. Mothers will participate in Mom-Net with either high- or low-intensity coaching as determined by which version their HS was randomized to offer. Coaching is provided by HS staff. In the high-intensity version, coaches provide support both for engaging with the intervention and for learning content. Coaching phone calls occur weekly (20-30 min call per session). In the low-intensity version, coaches provides supportive accountability for engaging with the intervention. Mothers participate in 4 (10-15) min calls occurring post-randomization, and 3- and 6-weeks later.

Group II: Treatment as Usual/WaitlistActive Control1 Intervention

HS sites provide ongoing social and instrumental support to parents, including helping to connect families to needed services including community mental health providers. Additionally, research staff will provide lists of local mental health providers and information to support treatment seeking. Research staff will also provide National Crisis Lines for Mental Health Emergencies. Staff will inform participants to call research staff if they have trouble accessing services so that staff may provide additional help. Finally, staff will share a case note documenting referrals with the women's family service worker, so that worker may provide locally based assistance to the woman in accessing services. Subsequent to T2 assessment, participants in the TAU/Waitlist condition, will be offered the Mom-Net intervention variant (high- v low-intensity coaching) being provided by their respective HS agencies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mom-Net

2012

N/A

~270

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) works by helping patients identify and change negative thought patterns and behaviors that contribute to their depression. It involves techniques such as cognitive restructuring, which challenges and modifies unhelpful thoughts, and behavioral activation, which encourages engagement in positive activities. Understanding these mechanisms is crucial for depression patients because it empowers them to actively participate in their treatment, leading to better management of symptoms and improved overall outcomes. Additionally, knowing how CBT works can help patients set realistic expectations and stay motivated throughout the therapy process.

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.

Find a Location

Who is running the clinical trial?

Oregon Research InstituteLead Sponsor

85 Previous Clinical Trials

61,014 Total Patients Enrolled

10 Trials studying Depression

1,816 Patients Enrolled for Depression

Lisa B Sheeber, Ph.D.Principal InvestigatorOregon Research Institute

Edward G Feil, Ph.D.Principal InvestigatorOregon Research Institute

1 Previous Clinical Trials

162 Total Patients Enrolled

Media Library

Mom-Net (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05142384 — N/A

Depression Research Study Groups: Mom-Net, Treatment as Usual/Waitlist

Depression Clinical Trial 2023: Mom-Net Highlights & Side Effects. Trial Name: NCT05142384 — N/A

Mom-Net (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142384 — N/A

~457 spots leftby Jun 2026

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