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

Trial Summary

What is the purpose of this trial?

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

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 data supports the idea that Problem-Solving Education for Maternal Depression is an effective treatment?

The available research shows that Problem-Solving Therapy (PST) is as effective as other therapies and medication treatments for reducing depression symptoms. It is significantly more effective than no treatment or just receiving support. Additionally, PST is more successful when it includes training in positive problem orientation and all major problem-solving skills. This suggests that PST can be a strong option for treating depression, including maternal depression. ^{1 2 3 4 5}

What safety data exists for Problem-Solving Therapy for maternal depression?

The research indicates that Problem-Solving Therapy (PST) is a well-examined cognitive-behavioral intervention for depression, showing effectiveness comparable to other psychosocial therapies and medications. It is significantly more effective than no treatment or support/attention control groups. The studies do not specifically address safety concerns, but the consistent effectiveness and widespread examination suggest it is a safe option for treating depression. The meta-analyses and trials included in the research focus on efficacy rather than safety, but the lack of reported adverse effects in these studies implies a favorable safety profile. ^{1 2 3 6 7}

Is Problem-Solving Education a promising treatment for maternal depression?

Yes, Problem-Solving Education (PSE) is a promising treatment for maternal depression. Research shows that problem-solving training can effectively reduce depression in pregnant women, making it a valuable approach for improving mental health during and after pregnancy. ^{8 9 10 11 12}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 '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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for depression: a meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Using Self-Guided Treatment Software (ePST) to Teach Clinicians How to Deliver Problem-Solving Treatment for Depression. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for adult depression: An updated meta-analysis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-centered approach to building problem solving skills among older primary care patients: problems identified and resolved. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of problem solving therapy for the treatment of major depressive disorder in older adults. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Problem-solving skills training for mothers of children with newly diagnosed cancer: a randomized trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of the Solution-Focused Model on Anxiety and Postpartum Depression in Nulliparous Pregnant Women. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. India pubmed.ncbi.nlm.nih.gov

Effectiveness of applying problem-solving training on depression in Iranian pregnant women: Randomized clinical trial. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Delivering maternal mental health through peer volunteers: a 5-year report. [2023]

12. Austria pubmed.ncbi.nlm.nih.gov

A systematic review of home-based interventions to prevent and treat postpartum depression. [2018]