Cognitive Behavioral Therapy for Depression

Recruiting at 1 trial location

Overseen By Gulcan Cil, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Institute

Disqualifiers: Psychosis, Major mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a program called Mom-Net can reduce depression in low-income mothers by providing online cognitive behavioral therapy (CBT) with coaching. It will assess Mom-Net's effectiveness and its delivery through Head Start centers. The trial includes two groups: one receiving the Mom-Net program with coaching, and the other receiving standard support with an option to try Mom-Net later. Mothers with noticeable depression symptoms and a child aged 2-5 in Head Start may qualify for this trial. As an unphased trial, this study offers a unique opportunity to access innovative therapy methods that could enhance mental health support for mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing therapy rather than changing medication use.

What prior data suggests that this cognitive behavioral therapy is safe for low income women of childbearing age?

Research has shown that internet-based cognitive behavioral therapy (ICBT), like Mom-Net, is generally safe and easy to use. Studies indicate that ICBT can help reduce symptoms of depression, anxiety, and stress. For example, one study found that participants using therapist-assisted ICBT experienced less anxiety and stress after childbirth and had better overall mental health.

Another study found that ICBT can be more accessible and affordable than traditional in-person therapy, making it easier for people to continue. While ICBT is effective in the short term, it also provides long-lasting mental health benefits.

Overall, research supports ICBT, such as Mom-Net, as a safe option for those seeking help with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mom-Net is unique because it targets maternal depression by integrating core Cognitive Behavioral Therapy (CBT) skills with parenting strategies, addressing the specific link between depression and parenting. Unlike traditional CBT, which focuses broadly on individual mental health, Mom-Net customizes its approach for mothers, making the therapy more relevant to their daily interactions with their children. Additionally, Mom-Net offers flexible coaching options, allowing participants to choose between high-intensity weekly support or more spaced-out, low-intensity check-ins, which can make the treatment more accessible and tailored to individual needs. Researchers are excited about Mom-Net because it not only aims to alleviate depression but also seeks to improve parenting dynamics, potentially offering a dual benefit.

What evidence suggests that Mom-Net is effective for reducing depression in low-income women?

Research has shown that Mom-Net, a treatment in this trial, is an online program using cognitive behavioral therapy (CBT) that effectively reduces depression symptoms. Studies have found that guided online CBT can significantly help with stress, anxiety, and depression, particularly in new mothers. In earlier trials of Mom-Net, participants experienced notable reductions in depression and improvements in parenting and their children's behavior. The program becomes even more effective with live coaching, enhancing engagement and support for parenting. Guided online CBT programs like Mom-Net offer more support and better results than those without guidance. Participants in this trial may receive Mom-Net with either high- or low-intensity coaching, while others will be in the Treatment as Usual/Waitlist group. ^{6 7 8 9 10}

Who Is on the Research Team?

Edward Feil, Ph.D.

Principal Investigator

Oregon Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child, aged 3-5, is enrolled in Head Start and I can communicate in English or Spanish.

I am a mother.

My child is between 3-5 years old and is enrolled in Head Start.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Head Start agencies are randomized to deliver Mom-Net with either high- or low-intensity coaching. Mothers participate in the Mom-Net program or receive Treatment as Usual (TAU).

5 months

Weekly coaching calls for high-intensity; 3 calls for low-intensity

Follow-up

Participants are monitored for changes in depressive symptoms, parenting behavior, and child adjustment.

12 months

Assessments at 5 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Mom-Net
• Treatment as Usual/Waitlist

Trial Overview 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.

How Is the Trial Designed?

Group I: Mom-Net Experimental Treatment 1 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/Waitlist Active Control 1 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.

Mom-Net is already approved in United States, Canada for the following indications:

Approved in United States as Mom-Net for:

• Maternal depression
• Postpartum depression

Approved in Canada as ICBT for:

• Postpartum depression

Who Is Running the Clinical Trial?

Oregon Research Institute

Lead Sponsor

Trials

87

Recruited

62,600+

Published Research Related to This Trial

Only 20.5% of primary care organizations in Sweden currently offer Internet-administered cognitive behavioral therapy (ICBT), despite its proven effectiveness for treating depression and anxiety, as recommended by national guidelines.

Implementing organizations reported fewer technical problems and greater resource availability for ICBT compared to nonimplementers, highlighting key barriers and facilitators that could inform future efforts to increase ICBT adoption in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Implementers and Nonimplementers of Internet-Administered Cognitive Behavioral Therapy for Depression and Anxiety: Survey of Primary Care Decision Makers in Sweden. Brantnell, A., Woodford, J., Baraldi, E., et al.[2021]

Self-guided internet-based cognitive behavioral therapy (iCBT) significantly reduces depressive symptoms compared to control groups, with a moderate effect size indicating its efficacy as a treatment option.

The study analyzed data from 3876 participants across 13 trials, showing that adherence to iCBT is linked to better treatment outcomes, suggesting that engagement with the program is crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. Karyotaki, E., Riper, H., Twisk, J., et al.[2022]

Adding scheduled telephone support (STS) to internet-delivered cognitive behavioral therapy (iCBT) significantly improved treatment adherence, with 58% of patients reaching midtreatment compared to 36% in the usual support group.

Patients receiving STS also showed greater improvement in depressive symptoms, with an average decrease of 3.63 points on the Beck Depression Inventory, compared to just 1.1 points in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scheduled Telephone Support for Internet Cognitive Behavioral Therapy for Depression in Patients at Risk for Dropout: Pragmatic Randomized Controlled Trial. Pihlaja, S., Lahti, J., Lipsanen, JO., et al.[2021]

A case study of a first-time mother with postpartum depression showed that therapist-assisted internet-delivered cognitive behavior therapy (ICBT) led to significant symptom reduction over 12 weeks, indicating its potential efficacy for treating PPD.

The participant reported high treatment satisfaction and a strong therapeutic alliance with her therapist, suggesting that this approach could be a valuable option for clinicians working with women experiencing PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet therapy for postpartum depression: a case illustration of emailed therapeutic assistance. Pugh, NE., Hadjistavropoulos, HD., Fuchs, CM.[2022]

The Thrive internet-based cognitive behavior therapy (iCBT) intervention significantly reduced depression and anxiety symptoms over 12 months, with improvements in work and social functioning and resilience, as evidenced by substantial reductions in scores on various mental health scales.

Higher adherence to the Thrive program, indicated by more logins and completed lessons, was associated with greater reductions in depression and anxiety symptoms, suggesting that engagement with the program enhances its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. Schure, M., McCrory, B., Tuchscherer Franklin, K., et al.[2021]

A study involving 141 participants with major depressive disorder found that both clinician-assisted and technician-assisted internet-based cognitive behavioral therapy (iCBT) led to significant reductions in depression scores, demonstrating large effect sizes comparable to traditional face-to-face treatments.

At a 4-month follow-up, participants in the technician-assisted group showed further improvements and had significantly lower depression scores than those in the clinician-assisted group, suggesting that technician guidance can be as effective as clinician guidance in iCBT for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance. Titov, N., Andrews, G., Davies, M., et al.[2022]

The BIP OCD Junior program, an internet-delivered cognitive behavioral therapy (ICBT) for children aged 7-11 with OCD, showed significant improvement in symptoms after 12 weeks, with a large effect size (Cohen's d = 1.86).

Both children and parents found the treatment credible and were highly satisfied, suggesting that ICBT could be a feasible option for young children with OCD, although further randomized controlled trials are needed to confirm its efficacy compared to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioural therapy for young children with obsessive-compulsive disorder: development and initial evaluation of the BIP OCD Junior programme. Aspvall, K., Andrén, P., Lenhard, F., et al.[2022]

A systematic review of 76 randomized controlled trials involving 11,704 participants found that behavioral activation in internet cognitive behavioral therapy (iCBT) may significantly reduce depression severity, while relaxation techniques could potentially be harmful.

Combining human and automated encouragement in iCBT programs was shown to decrease dropout rates, suggesting that support mechanisms are crucial for maintaining engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Furukawa, TA., Suganuma, A., Ostinelli, EG., et al.[2022]

Therapist-supported Internet-based cognitive behavior therapy (iCBT) significantly reduces stress, anxiety, and depressive symptoms in postpartum women, with effect sizes ranging from small to large based on a meta-analysis of 8 randomized controlled trials involving 1523 participants.

The majority of the studies (65%) showed a low risk of bias, indicating reliable results, and the findings suggest that iCBT can be an effective intervention for improving mental health in postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-Supported Internet-Based Cognitive Behavior Therapy for Stress, Anxiety, and Depressive Symptoms Among Postpartum Women: A Systematic Review and Meta-Analysis. Lau, Y., Htun, TP., Wong, SN., et al.[2022]

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Internet-Based Cognitive Behavioral Therapy for Depression In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression.

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