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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

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 data supports the effectiveness of the treatment Problem Solving Therapy for Depression?

Research shows that Problem Solving Therapy (PST) is effective in reducing depression symptoms, being as effective as other therapies and medications. It is particularly beneficial when it includes training in positive problem orientation and all major problem-solving skills. Additionally, PST has been effective in managing depression and anxiety in primary care patients. ^{1 2 3 4 5}

Is Problem Solving Therapy safe for humans?

Problem Solving Therapy (PST) is generally considered safe for humans, as it is a type of talk therapy that helps people develop problem-solving skills. It has been used successfully in various settings, including primary care, and for different conditions like depression and anxiety, without reports of harm. ^{1 2 3 4 6}

How is Problem Solving Therapy (PST) different from other treatments for depression?

Problem Solving Therapy (PST) is unique because it focuses on teaching adaptive problem-solving skills and attitudes, which include defining problems, generating alternatives, making decisions, and implementing solutions. It is equally effective as other therapies and medications but stands out by emphasizing a positive problem orientation and comprehensive skill training. ^{3 4 5 7 8}

Research Team

Victoria Tang, MD, MAS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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 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]

References

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

Early intervention to preempt major depression among older black and white adults. [2023]

2. 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]

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

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

4. United States 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. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

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

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

Problem adaptation therapy for older adults with major depression and cognitive impairment: a randomized clinical trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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