Problem-Solving Education for Maternal Depression

Overseen By Amy Yule, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Suicidal ideation, Cognitive limitation

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

388 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help mothers with depression, called stepped-care intervention. The goal is to determine if this approach can prevent depression and encourage those already experiencing it to seek help. Mothers in the trial will either receive usual support or participate in special problem-solving education sessions (a type of therapy), with additional engagement sessions for those with more severe symptoms. The trial seeks mothers of young children in Head Start programs in Massachusetts who speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for mothers.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this stepped-care intervention is safe for addressing maternal depression?

Research shows that problem-solving education (PSE) can help prevent symptoms of depression by lowering stress, a common precursor to depression. Studies have found that PSE is as effective as other therapies and medications in reducing depression symptoms, with no major safety issues reported.

Engagement sessions also help prevent depression and improve mood over time. Research has shown that these sessions safely reduce depression symptoms, indicating they are generally safe for participants.

Both PSE and engagement sessions have research support for their safety and effectiveness. Participants in past studies have not reported major side effects, suggesting these treatments are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Problem-Solving Education (PSE) and Engagement Sessions for maternal depression because these approaches offer a tailored, proactive way to address mental health in mothers. Unlike standard treatments that often rely on medication or traditional therapy, PSE empowers mothers by teaching them practical problem-solving skills to manage stress and depressive symptoms. Additionally, the Engagement Sessions provide personalized support to mothers with higher depressive symptoms, ensuring they receive the right level of care. This stepped-care approach is unique because it adapts to the individual's needs, potentially enhancing engagement and outcomes.

What evidence suggests that this trial's treatments could be effective for maternal depression?

Research shows that problem-solving education (PSE), which participants in this trial may receive, can help prevent depression by reducing stress. PSE, a form of cognitive behavioral therapy (CBT), has proven effective in preventing depression. Studies also indicate that participating in these sessions can lessen depressive symptoms over time. Specifically, mothers involved in these sessions experienced noticeable improvements in mood and daily life. Overall, strong evidence supports these methods in managing and reducing depression. Meanwhile, participants in the usual care control group will receive standard Head Start services. ^{6 7 8 9 10}

Who Is on the Research Team?

Amy Yule, MD

Principal Investigator

Boston Medical Center

Emily Feinberg, ScD CPNP

Principal Investigator

Brown University

Michael Silverstein, MD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for mothers of children aged 0-5 enrolled in Head Start programs, who will continue to receive services for at least a year. Participants must report feelings of depression or loss of pleasure and be Medicaid beneficiaries. They should also speak English or Spanish.

Inclusion Criteria

The mother shows signs of feeling very sad or losing interest in things on the PHQ-9 questionnaire.

I am a mother of a young child in Head Start for the next 12 months.

The participant's mother is covered by Medicaid.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive a stepped-care intervention based on their depressive symptoms, including problem-solving education or engagement sessions

12 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Outcome Assessment

Assessment of maternal depressive symptoms, child absenteeism, and other secondary outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Engagement sessions
• Problem-solving education (PSE)
• Usual care

Trial Overview The study tests a stepped-care intervention (SCI) aimed at preventing and managing maternal depression within Head Start centers. It includes problem-solving education (PSE), engagement sessions, and usual care, with the approach tailored to the severity of symptoms.

How Is the Trial Designed?

Group I: Stepped-care intervention (SCI) group Experimental Treatment 2 Interventions

In the SCI group, mothers with low baseline depressive symptoms are offered the problem-solving education (PSE) prevention intervention, and mothers with greater depressive symptoms are offered Engagement Sessions.

Group II: Usual care control group Active Control 1 Intervention

Families in the control group will receive usual Head Start services.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Published Research Related to This Trial

The 'Gruen' Postpartum Depression Group Therapy, a ten-week intervention, significantly reduced depression scores in postpartum mothers, as measured by the Beck Depression Inventory II.

Participants found psychoeducation to be the most beneficial aspect of the therapy, highlighting the importance of providing information and support to mothers who may struggle to attend traditional therapy due to childcare responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group therapy and its barriers for women suffering from postpartum depression. Ugarriza, DN.[2019]

Problem-solving therapy (PST) is likely an effective treatment for adult depression, showing a moderate effect size of g=0.79 compared to control groups across 30 randomized controlled trials involving 3530 patients.

When compared to other psychotherapies, PST's effectiveness is similar, with a small effect size of g=0.34 in studies with low risk of bias, indicating that while PST may be slightly more effective, the differences are not significant when accounting for researcher bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for adult depression: An updated meta-analysis. Cuijpers, P., de Wit, L., Kleiboer, A., et al.[2020]

Problem-Solving Therapy (PST) is as effective as other psychosocial therapies and medications for reducing depressive symptoms, based on a meta-analysis of 21 independent studies.

PST shows greater effectiveness when it includes training in a positive problem orientation and all four major problem-solving skills, suggesting that a comprehensive approach enhances its therapeutic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for depression: a meta-analysis. Bell, AC., D'Zurilla, TJ.[2022]

Problem solving therapy (PST) is significantly more effective than no treatment, standard treatment, and attention placebo, with a large effect size of 1.37 compared to no treatment and moderate effect sizes of 0.54 for both treatment as usual and attention placebo, based on a meta-analysis of 31 studies involving 2895 participants.

PST's effectiveness does not significantly surpass that of other established treatments, indicating that while it is beneficial, it may not be superior to existing therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis. Malouff, JM., Thorsteinsson, EB., Schutte, NS.[2022]

A peer-delivered version of the WHO's Thinking Healthy Programme for perinatal depression in Pakistan and India has shown sustained effectiveness, with about 70% of peer volunteers remaining active after 5 years, indicating strong retention and competency in delivering the intervention.

Factors such as altruism, improved social status, and personal mental health benefits contributed to the volunteers' motivation, suggesting that community-based interventions can be sustainable even in low-resource settings, although challenges like financial incentives and logistical issues remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering maternal mental health through peer volunteers: a 5-year report. Atif, N., Bibi, A., Nisar, A., et al.[2023]

In a study involving 107 older primary care patients, Problem Solving Therapy (PST) led to a resolution of 59% of the 568 problems identified, highlighting its effectiveness in addressing health-related issues.

Patients were 2.2 times more likely to resolve their own identified problems compared to those identified by healthcare professionals, suggesting that PST empowers patients to take charge of their health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered approach to building problem solving skills among older primary care patients: problems identified and resolved. Enguidanos, S., Coulourides Kogan, A., Keefe, B., et al.[2018]

Problem Solving Therapy (PST) significantly reduces depressive symptoms in older adults with Major Depressive Disorder (MDD), as shown in a meta-analysis of nine studies involving 569 participants, with a notable effect size (d = 1.15).

PST not only alleviates depression but also helps reduce disability, indicating its potential as an effective treatment option for older adults suffering from MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of problem solving therapy for the treatment of major depressive disorder in older adults. Kirkham, JG., Choi, N., Seitz, DP.[2018]

A randomized clinical trial involving 70 pregnant women showed that problem-solving training significantly reduced depression scores in the experimental group, from an average of 16.06 to 12.83 immediately after the intervention.

In contrast, the control group, which only received routine prenatal care, did not show a significant change in depression scores, highlighting the effectiveness of problem-solving training as a supportive intervention for maternal mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of applying problem-solving training on depression in Iranian pregnant women: Randomized clinical trial. Khamseh, F., Parandeh, A., Hajiamini, Z., et al.[2020]

Home-based psychological interventions, including cognitive behavioral, psychodynamic, and non-directive counseling approaches, have been shown to significantly reduce postpartum depression (PPD) in four out of six studies reviewed.

The review highlights the need for further research to identify factors that influence the effectiveness of these interventions and to develop targeted prevention strategies for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of home-based interventions to prevent and treat postpartum depression. Leis, JA., Mendelson, T., Tandon, SD., et al.[2018]

The Solution-Focused Model (SFM) significantly reduced anxiety and postpartum depression (PPD) scores in nulliparous pregnant women compared to routine care, as assessed at multiple points during and after pregnancy.

SFM also improved sleep quality and resulted in higher nursing satisfaction among participants, indicating its effectiveness as a supportive intervention during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of the Solution-Focused Model on Anxiety and Postpartum Depression in Nulliparous Pregnant Women. Huang, C., Han, W., Hu, S.[2022]

The electronic Problem-Solving Treatment (ePST) program significantly improved the knowledge of 13 social workers and trainees about PST, with a notable increase in their understanding after using the program (P = .001).

Participants demonstrated sufficient competence to begin practicing PST under supervision after using ePST, suggesting that this self-instructional method could help widely disseminate effective depression treatment, although ongoing supervision is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Self-Guided Treatment Software (ePST) to Teach Clinicians How to Deliver Problem-Solving Treatment for Depression. Cartreine, JA., Chang, TE., Seville, JL., et al.[2021]

A study involving 92 mothers of newly diagnosed pediatric cancer patients showed that an 8-week problem-solving skills training (PSST) intervention significantly improved their problem-solving abilities and reduced negative feelings like depression and anxiety compared to standard care.

The improvement in mood was largely linked to better problem-solving behaviors, with the greatest benefits seen in constructive problem-solving, suggesting that enhancing these skills can effectively support mothers facing the stress of their children's serious illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving skills training for mothers of children with newly diagnosed cancer: a randomized trial. Sahler, OJ., Varni, JW., Fairclough, DL., et al.[2022]

Citations

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Perinatal depression and sun safety behaviors: Results of ... These data suggest that baseline sun safety behaviors may be a stronger indicator of future sun safety behaviors than affect at baseline for expectant mothers.