Problem Solving Therapy for Depression

(BRSR Trial)

Overseen By Victoria Tang, MD, MAS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Severe cognitive impairment, Substance abuse, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether problem-solving therapy can assist older adults facing depression before major surgery. The research aims to determine the practicality and acceptability of this therapy for patients both pre- and post-surgery. Participants will receive either structured therapy sessions or enhanced usual care, which includes additional mental health education. Suitable candidates are aged 65 or older, preparing for major surgery with a hospital stay of three or more days, and experiencing depressive symptoms such as low mood or lack of interest in daily activities. As an unphased trial, this study provides a unique opportunity to enhance understanding of how therapy can improve mental health outcomes in older adults undergoing surgery.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Problem Solving Therapy (PST) is safe for older adults undergoing major surgery?

Research has shown that Problem Solving Therapy (PST) is generally safe and well-tolerated. In past studies, PST successfully helped people with depression, including older adults, without major safety concerns. For example, one study found that older adults with depression and mild memory problems improved without serious side effects. Another review found that PST was as effective as other therapies and medications, with no additional safety risks.

Since PST is a type of talk therapy, it doesn't involve medication or physical procedures, often resulting in fewer side effects. Overall, PST has been used in various settings with positive results and minimal negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Problem Solving Therapy (PST) is unique because it empowers patients to tackle depression by teaching them practical problem-solving skills. Unlike traditional antidepressants or talk therapies, PST is delivered through convenient videoconferencing or phone calls, making it more accessible and flexible for patients. Researchers are excited about PST because it not only helps patients identify and solve their problems but also monitors the effectiveness of their solutions, potentially leading to sustainable mental health improvements.

What evidence suggests that Problem Solving Therapy might be an effective treatment for depression?

Research has shown that Problem Solving Therapy (PST), which participants in this trial may receive, effectively treats depression. Studies have found that people with depression who receive PST improve faster than those who do not. A meta-analysis, which combines results from many studies, found PST to be as effective as other therapies and some medications for depression. Additionally, PST has successfully reduced symptoms of depression in older adults and those with anxiety. These findings suggest that PST can be a promising option for managing depression, especially in older adults facing surgery. Participants in the control arm of this trial will receive "enhanced usual care," which includes additional mental health education. ^{2 6 7 8 9}

Who Is on the Research Team?

Victoria Tang, MD, MAS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for older adults who are about to have major surgery and either feel depressed or lack social support. It's designed to see if a type of counseling called Problem Solving Therapy (PST) can help them before and after the operation.

Inclusion Criteria

I am scheduled for a major surgery that will require a hospital stay of more than 3 days.

I am 65 years old or older on the day of my surgery.

I have had major surgery, such as for bones, chest, abdomen, or heart.

Exclusion Criteria

Those with severe cognitive impairment (Short Portable Mental Status Questionnaire--SPMSQ: screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment)

Unable to read, speak, and understand English

Current alcohol or other substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive 2-3 sessions of Problem Solving Therapy (PST) before surgery

2-3 weeks

2-3 sessions (virtual or phone)

Post-operative Treatment

Participants receive 6-7 sessions of Problem Solving Therapy (PST) after surgery

6-7 weeks

6-7 sessions (virtual or phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Problem Solving Therapy (PST)

Trial Overview

The study is testing Problem Solving Therapy (PST), which is a counseling technique aimed at improving mental health and potentially aiding recovery in older patients undergoing surgery.

How Is the Trial Designed?

Group I: Problem Solving Therapy (PST) Experimental Treatment 1 Intervention

Participants in the intervention arm will receive Problem Solving Therapy (PST). Meetings via videoconferencing or phone will occur at a frequency of 1 time every week for an estimated 2-3 sessions before surgery and 6-7 sessions after surgery for a total of 9 sessions. Essential components of the PST that the patient will be taught include: (1) define the nature of the problem, (2) generate wide range of possible solutions, (3) systematically evaluate the potential solutions and select the most optimal ones to implement, and (4) monitor and evaluate the actual solution outcome after implementation.

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

Participants in the control arm will receive "enhanced usual care". They will receive additional mental health education in the form of educational handouts mailed or emailed to them.

Problem Solving Therapy (PST) is already approved in United States for the following indications:

Approved in United States as Problem-Solving Therapy for:

• Major Depression
• Executive Dysfunction
• Geriatric Depression

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Problem-solving therapy (PST) is effective in managing depression and anxiety among primary care patients, showing a significant treatment effect size of 0.673 based on a systematic review of 11 studies involving 2072 participants.

PST delivered by physicians also demonstrated a meaningful, though smaller, effect size of 0.35, indicating that even brief interventions in primary care can lead to improvements in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Problem-Solving Therapy for Primary Care Patients' Depressive and/or Anxiety Disorders: A Systematic Review and Meta-Analysis. Zhang, A., Park, S., Sullivan, JE., et al.[2019]

Problem solving therapy (PST) is an effective psychological strategy for treating common mental health conditions, showing similar efficacy to antidepressants in managing depression.

PST empowers patients by teaching them problem-solving skills that can be applied to their specific life challenges, making it a suitable intervention in general practice settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem solving therapy - use and effectiveness in general practice. Pierce, D.[2012]

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) 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 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 for primary care (PST-PC) and dietary coaching were both effective in preventing major depression episodes in older adults with subsyndromal depressive symptoms, with low incidence rates observed over two years (9% in blacks and 8% in whites).

Participants experienced a sustained mean decrease of 4 points in depressive symptoms over the study period, suggesting that both interventions could be safe and scalable options for preventing depression in diverse older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention to preempt major depression among older black and white adults. Reynolds, CF., Thomas, SB., Morse, JQ., et al.[2023]

In a randomized clinical trial involving 74 older adults with major depression and cognitive impairment, Problem Adaptation Therapy (PATH) significantly reduced depression and disability compared to supportive therapy for cognitively impaired patients (ST-CI) over 12 weeks.

PATH led to a higher remission rate of depression (37.84% vs 13.51%) and demonstrated greater efficacy in improving emotional regulation and overall well-being, highlighting its potential as a valuable treatment option for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem adaptation therapy for older adults with major depression and cognitive impairment: a randomized clinical trial. Kiosses, DN., Ravdin, LD., Gross, JJ., et al.[2021]

Problem-solving treatment (PST) is an effective brief psychological intervention for patients with major depression and other emotional disorders in primary care settings, as reviewed in studies conducted in Oxford.

While PST may have higher direct costs compared to usual treatments, it could lead to greater overall savings when considering indirect costs, making it a feasible option for managing mild to moderate mental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving treatment: evidence for effectiveness and feasibility in primary care. Mynors-Wallis, L.[2017]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2593861/

Problem-Solving Treatment and Coping Styles in Primary ...

Analysis using linear mixed modeling revealed significant effects of treatment and coping such that those in PST-PC improved at a faster rate, and those ...

2.

jabfm.org

jabfm.org/content/31/1/139.full-text.pdf

The Effectiveness of Problem-Solving Therapy for Primary ...

Conclusions: Results from the study supported PST's effectiveness for primary care depression and/or anxiety. Our preliminary results also ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10262169/

Problem Adaptation Therapy (PATH): Origins, Current ...

An intervention designed to help reduce depression and disability in older adults with major depression and cognitive impairment.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0272735809000269

Problem-solving therapy for depression: A meta-analysis

Based on results involving 21 independent samples, PST was found to be equally effective as other psychosocial therapies and medication treatments and ...

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psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ps.201900100

Moderators of Outcome in Problem-Solving Therapy for ...

HIGHLIGHTS. •. Depressive symptoms improved more over time among women offered problem-solving therapy in primary care settings than among men.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4583822/

Problem Adaptation Therapy (PATH) for Older Adults with ...

PATH is a treatment for older adults with major depression, cognitive impairment (from mild cognitive deficits to moderate dementia) and disability.

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researchgate.net

researchgate.net/publication/242658685_Problem-Solving_Treatment_for_Primary_Care_PST-PC_A_Treatment_Manual_for_Depression

Problem-Solving Treatment for Primary Care (PST-PC)

Problem Solving therapy (PST) is a low intensity cognitive-behavioral intervention that focuses on training in adaptive problem-solving attitudes and skills.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2943727/

Problem Solving Therapy for Subthreshold Depression in ...

Results of this pilot randomized controlled trial indicated that the Problem Solving Therapy in Home Care (PST-HC) intervention had significant positive effects ...

9.

jamanetwork.com

jamanetwork.com/journals/jamapsychiatry/fullarticle/1922089

Problem Adaptation Therapy for Older Adults With Major ...

Problem-solving therapy led to greater reduction in depression and disability than supportive therapy in older adults with MDD and mild executive dysfunction.