← Back to Search

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

Study Summary

This trial is examining whether the Mom-Net cognitive behavioral treatment for depression can be delivered successfully by Head Start agencies, with the goal of reducing maternal depression.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implementation Reach (IReach)
Maternal Acceptability (Modified System Usability Scale)
Maternal Engagement (Engage)
+2 more
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Oregon Research InstituteLead Sponsor
84 Previous Clinical Trials
65,307 Total Patients Enrolled
10 Trials studying Depression
1,632 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: Treatment as Usual/Waitlist, Mom-Net
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities for participants in this trial?

"Clinicaltrials.gov states that this trial, first published on October 28th 2022, is still accepting participants. The study's information was last revised on December 1st 20202."

Answered by AI

How many participants are being monitored in this experiment?

"Absolutely. Clinicaltrials.gov reveals that the study, which was initially made public on October 28th 2022, is currently recruiting patients. About 1200 participants are required from 1 research centre."

Answered by AI

What are the core aims of this investigation?

"The primary goal of this 5-month trial is to ascertain its Implementation Reach (IReach). Secondary objectives include the Parent Behavior Inventory (PBI) which assesses maternal behaviour by assigning a rating from 0 to 5 on each item, then summing for subscale totals; Supportive/Engaged sub-scale range 0-55 and Hostile/Coercive subscale range 0-45. Additionally, a Child Behavior Checklist (CBCL 1 ½ - 5 years), with raw score ranges of Internalizing (36 items) = 0-72 and Externalizing (24 items) =0–48 will be used in"

Answered by AI

Who else is applying?

What site did they apply to?
Oregon Research Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I hate my depression and my meds are not helping as much as I’d like.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start
2022. "ICBT (Internet Based Cognitive Behavioral Therapy) for Maternal Depression: Community Implementation in Head Start". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05142384.
~571 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top