Problem-Solving Therapy for Caregiver Stress

Enrolling by invitation at 3 trial locations

Overseen By George Demiris, Ph.D., FACMI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Paid caregiver, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Problem-Solving Therapy to help family caregivers manage stress while caring for loved ones with cancer who receive outpatient palliative care. Participants will be divided into groups; some will receive the therapy, while others will have supportive visits without therapy. The goal is to determine if this therapy helps caregivers better handle stress and challenges. This trial suits unpaid family caregivers involved in caring for someone with cancer who is receiving outpatient palliative care. As an unphased trial, it offers caregivers the opportunity to explore new ways to manage stress and improve their caregiving experience.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that Problem-Solving Therapy is safe for caregivers?

Research has shown that caregivers have responded positively to problem-solving therapy in past studies. For instance, one study found that 60.4% of caregivers experienced a significant reduction in stress after participating. This suggests the therapy can be beneficial without causing harm.

No serious side effects have been reported from this therapy. Problem-solving therapy is a talking-based treatment that helps people manage problems more effectively. It does not involve medication or physical treatments, typically resulting in fewer side effects.

Overall, problem-solving therapy appears to be a safe option for reducing caregiver stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Problem-Solving Therapy (PST) for caregiver stress because it offers a fresh approach by enhancing caregivers' skills in tackling everyday challenges. Unlike standard therapies that may focus on emotional support or medication, PST empowers caregivers by teaching them practical problem-solving strategies, which can lead to greater self-sufficiency and reduced stress. This method not only strengthens caregivers' ability to manage stress but also integrates seamlessly with existing outpatient palliative care services, potentially maximizing its impact without significant disruption to current care routines.

What evidence suggests that Problem-Solving Therapy might be an effective treatment for caregiver stress?

Research has shown that Problem-Solving Therapy (PST) can help reduce stress and depression for caregivers. In past studies, caregivers who tried PST showed noticeable improvements in managing their stress and depression. PST proved especially effective at lowering depression compared to other educational programs. Caregivers also felt more capable and better at managing their tasks after PST. In this trial, some caregivers will participate in the Problem-Solving Therapy intervention, while others will receive attention-matched control sessions. These findings suggest that PST can be a useful tool for caregivers facing emotional challenges. ^{6 7 8 9 10}

Who Is on the Research Team?

Karla Washington, Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for unpaid family caregivers of cancer patients receiving outpatient palliative care, regardless of legal or biological relationship. Participants must be over 18 and involved in the patient's care at one of the clinical sites. They need to consent to join the study.

Inclusion Criteria

You must work for or be associated with the healthcare system that is part of the clinical trial.

You are taking care of a family member with cancer who is receiving palliative care as an outpatient. You don't get paid for your caregiving work. It's okay if you don't have a legal or biological relationship with the patient.

Requirements for non-family caregivers who want to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a three-session problem-solving therapy intervention or three sessions of attention-matched control in addition to usual care

4 weeks

3 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in anxiety, depression, and positive aspects of caregiving

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Problem-Solving Therapy

Trial Overview The study tests problem-solving therapy for these caregivers, comparing it with an attention-matched control group. Caregivers are randomly assigned to either receive this specific therapy or participate in interviews that match for time and attention but don't include therapeutic intervention.

How Is the Trial Designed?

Group I: Problem Solving Therapy Intervention Experimental Treatment 1 Intervention

Family caregivers in the intervention study arm will participate in three problem-solving therapy sessions with a trained interventionist in addition to receiving the services and support provided as part of usual outpatient palliative care.

Group II: In-Depth Interviews for non-FCG Stakeholders Experimental Treatment 1 Intervention

Each year of the project, the investigators will recruit 6 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the PST intervention into clinical practice for a total of 30 unique stakeholders who will be interviewed over the duration of this 5-year study.

Group III: Attention Control Placebo Group 1 Intervention

Family caregivers in the attention control study arm will receive three sessions of attention-matched control in addition to the services and support provided as part of usual outpatient palliative care. Attention-matched control will consist of three "friendly visits" with a trained research staff person.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41142740/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0xg0ltB9IaEqEAiUOKhgoUkCsKVd-ibxpiQXcNIy3KG&fc=None&ff=20251028133121&v=2.18.0.post22+67771e2

Problem-solving training to improve caregiver burden and ... Conclusion: Most caregivers demonstrated a clinically meaningful improvement in caregiver burden and/or depressive symptoms after receiving PST/ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4021000/

Effects of Problem Solving Therapy on Mental ... Relative to nutritional education, PST led to significantly reduced depression symptoms, particularly among early dementia caregivers. PST also lowered ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224005672

Evaluation of a problem-solving (PS) techniques-based ... Carers in the intervention group showed significantly improved task-oriented coping, mastery, and competence and significantly reduced emotion-oriented coping, ...

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1682373/pdf

Problem-solving training to improve caregiver burden and ... PST has demonstrated efficacy in improving caregiver burden and reducing mood symptoms (22, 24, 27–30, 37) and negative problem-solving.

5. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(25)00232-7/fulltext

Three versus six sessions of problem-solving training with ... PST/DSJ was effective for improving caregiver burden and depressive symptoms in as few as three sessions without boosters, though six sessions may have greater ...

6. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1682373/full

Problem-solving training to improve caregiver burden and ... Results: Ninety-one caregivers were included in responder analysis, with 55 (60.4%) demonstrating a clinically meaningful improvement in caregiver burden and/or ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK2665/

Supporting Family Caregivers in Providing Care - NCBI - NIH Caregiver burden and strain have been related to the caregiver's own poor health status, increased health-risk behaviors (such as smoking), and higher use of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2579756/

Resources for Enhancing Alzheimer's Caregiver Health ... A long-term education intervention based in a primary care setting was effective in reducing caregiver stress and burden. Miami, Family-based Structural Multi- ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S019745722030241X

The safety challenges of therapeutic self-care and informal ... As a result of the high levels of anxiety, some ICs reported psychological distress associated with the burden of care. In particular, ICs reported the most ...

10. research.aota.org research.aota.org/ajot/article/78/2/7802390010/25081/Occupational-Therapy-Interventions-for-Caregivers

Occupational Therapy Interventions for Caregivers of People ... The burden of caregiving often leads to poorer physical and emotional health for the caregiver ... safety, sequencing, and problem solving ...