~249 spots leftby Apr 2028

Problem-Solving Education for Maternal Depression

Recruiting in Palo Alto (17 mi)
Overseen byMichael Silverstein, MD MPH
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brown University
Disqualifiers: Suicidal ideation, Cognitive limitation
No Placebo Group

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.

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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.

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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.

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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.
My mother speaks English or Spanish.
+1 more

Trial 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

Participant Groups

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Stepped-care intervention (SCI) groupExperimental Treatment2 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 groupActive Control1 Intervention
Families in the control group will receive usual Head Start services.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Boston Medical CenterBoston, MA
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Who Is Running the Clinical Trial?

Brown UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
Boston Medical CenterCollaborator

References

Using Self-Guided Treatment Software (ePST) to Teach Clinicians How to Deliver Problem-Solving Treatment for Depression. [2021]Problem-solving treatment (PST) offers a promising approach to the depression care; however, few PST training opportunities exist. A computer-guided, interactive media program has been developed to deliver PST electronically (ePST), directly to patients. The program is a six-session, weekly intervention modeled on an evidence-based PST protocol. Users are guided through each session by a clinician who is presented via hundreds of branching audio and video clips. Because expert clinician behaviors are modeled in the program, not only does the ePST program have the potential to deliver PST to patients but it may also serve as a training tool to teach clinicians how to deliver PST. Thirteen social workers and trainees used ePST self-instructionally and subsequently attended a day-long workshop on PST. Participants' PST knowledge level increased significantly from baseline to post-ePST (P = .001) and did not increase significantly further after attending the subsequent workshop. Additionally, attending the workshop did not significantly increase the participants' skill at performing PST beyond the use of the ePST program. Using the ePST program appears to train novices to a sufficient level of competence to begin practicing PST under supervision. This self-instructional training method could enable PST for depression to be widely disseminated, although follow-up supervision is still required.
Problem-solving therapy for depression: a meta-analysis. [2022]Problem-Solving Therapy (PST) is a cognitive-behavioral intervention that focuses on training in adaptive problem-solving attitudes and skills. The purpose of this paper was to conduct a meta-analysis of controlled outcome studies on efficacy of PST for reducing depressive symptomatology. Based on results involving 21 independent samples, PST was found to be equally effective as other psychosocial therapies and medication treatments and significantly more effective than no treatment and support/attention control groups. Moreover, component analyses indicated that PST is more effective when the treatment program includes (a) training in a positive problem orientation (vs. problem-solving skills only), (b) training in all four major problem-solving skills (i.e., problem definition and formulation, generation of alternatives, decision making, and solution implementation and verification), and (c) training in the complete PST package (problem orientation plus the four problem-solving skills).
Problem-solving therapy for adult depression: An updated meta-analysis. [2020]Problem-solving therapy (PST) is one of the best examined types of psychotherapy for adult depression. No recent meta-analysis has examined the effects of PST compared to control groups or to other treatments. We wanted to verify whether PST is effective, whether effects are comparable to those of other treatments, and whether we could identify the possible sources of high heterogeneity that was found in earlier meta-analyses.
Patient-centered approach to building problem solving skills among older primary care patients: problems identified and resolved. [2018]This article describes problems identified by older primary care patients enrolled in Problem Solving Therapy (PST), and explores factors associated with successful problem resolution. PST patients received 1 to 8, 45-min sessions with a social worker. Patients identified problems in their lives and directed the focus of subsequent sessions as consistent with the steps of PST. The 107 patients identified 568 problems, 59% of which were resolved. Most commonly identified problems included health related issues such as need for exercise or weight loss activities, medical care and medical equipment needs, home and garden maintenance, and gathering information on their medical condition. Problems identified by patients were 2.2 times more likely to be solved than those identified by a health care professional. Using PST in primary care may facilitate patients in addressing key health and wellness issues.
Meta-analysis of problem solving therapy for the treatment of major depressive disorder in older adults. [2018]Major depressive disorder (MDD) affects many older adults and is associated with poor medical and mental health outcomes. Problem Solving Therapy (PST) has emerged as a promising psychotherapy for MDD in older adults, although the efficacy of PST in this population has not been well described. We examined the effectiveness of PST for the treatment of MDD in older adults in a systematic review and meta-analysis.
Problem-solving skills training for mothers of children with newly diagnosed cancer: a randomized trial. [2022]Mothers of children with serious illnesses have lower levels of well-being than mothers in the general population. Problem-solving therapy (PST), a cognitive-behavioral intervention, has been shown to be effective in treating negative affectivity (depression, anxiety) and other manifestations of reduced well-being. This report describes a problem-solving skills training (PSST) intervention, based on problem-solving therapy, for mothers of newly diagnosed pediatric cancer patients. Ninety-two mothers were randomly assigned to receive PSST or to receive standard psychosocial care (Control Group). After the 8-week intervention, mothers in the PSST Group had significantly enhanced problem-solving skills and significantly decreased negative affectivity compared with controls. Analysis revealed that changes in self-reports of problem-solving behaviors accounted for 40% of the difference in mood scores between the two groups. Interestingly, PSST had the greatest impact on improving constructive problem solving, whereas improvement in mood was most influenced by decreases in dysfunctional problem solving. The implications of these findings for refinement of the PSST intervention and for extension to other groups of children with serious illnesses are discussed.
The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis. [2022]This paper describes a meta-analysis of 31 studies that examined the efficacy of problem solving therapy (PST). The meta-analysis, encompassing 2895 participants, showed that PST is significantly more effective than no treatment (d=1.37), treatment as usual (d=0.54), and attention placebo (d=0.54), but not significantly more effective than other bona fide treatments offered as part of a study (d=0.22). Significant moderators included whether the PST included problem-orientation training, whether homework was assigned, and whether a developer of PST helped conduct the study.
The Effects of the Solution-Focused Model on Anxiety and Postpartum Depression in Nulliparous Pregnant Women. [2022]Solution-focused model (SFM) is an intervention method that fully mobilizes patients' initiative through their potential. We aimed to investigate the effects of SFM on anxiety and postpartum depression (PPD) in nulliparous pregnant women compared with routine care services.
Group therapy and its barriers for women suffering from postpartum depression. [2019]Data were collected to pilot-test the feasibility and the effects of the "Gruen" Postpartum Depression Group Therapy as an intervention for depression for a small treatment and control group of postpartum depressed mothers. Treatment was a ten-week group therapy consisting of four interacting aspects: (1) education and information, (2) stress reduction techniques,(3) development of support systems, and (4) cognitive restructuring. Beck Depression Inventory II scores were significantly lower post treatment in the treatment group. Women stated psychoeducation was the greatest help to them. One of the problems associated with treating postpartum women was their inability to get to therapy because of childcare responsibilities.
Effectiveness of applying problem-solving training on depression in Iranian pregnant women: Randomized clinical trial. [2020]Depression during pregnancy is one of the major concerns in mental health, hence using interventional methods for the treatment or reducing the rate of depression is considered a priority for maternal and fetal health. The present study aimed to examine the effectiveness of problem-solving training in reducing depression in pregnant women.
Delivering maternal mental health through peer volunteers: a 5-year report. [2023]Label="BACKGROUND" NlmCategory="BACKGROUND">Maternal depression affects one in five women in low-and middle income countries (LMIC) and has significant economic and social impacts. Evidence-based psychosocial interventions delivered by non-specialist health workers are recommended as first-line management of the condition, and recent studies on such interventions from LMIC show promising results. However, lack of human resource to deliver the interventions is a major bottle-neck to scale-up, and much research attention has been devoted to 'task-sharing' initiatives. A peer-delivered version of the World Health Organization's Thinking Healthy Programme for perinatal depression in Pakistan and India showed clinical, functional and social benefits to women at 3 months postpartum. The programme has been iteratively adapted and continually delivered for 5 years in Pakistan. In this report, we describe the extended intervention and factors contributing to the peers' continued motivation and retention, and suggest future directions to address scale-up challenges.
A systematic review of home-based interventions to prevent and treat postpartum depression. [2018]This systematic review evaluated randomized controlled trials assessing home-based psychological interventions to prevent and treat postpartum depression (PPD). Six studies meeting inclusion criteria were identified, five assessing treatments for PPD and one assessing a preventive intervention for PPD. Interventions used cognitive behavioral, psychodynamic, and non-directive counseling approaches. Of the six studies reviewed, four reported statistically significant treatment effects on PPD following the intervention. Each of the three types of psychological interventions were shown to reduce levels of maternal depression. Recommendations for future development and evaluation of home-based psychological interventions for PPD are discussed. These include identification of mediators and moderators of intervention efficacy, exploring strategies for prevention of PPD, and targeting high-risk groups.