Problem-Solving Therapy for Caregiver Stress

Recruiting at 2 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

530 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

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 data supports the effectiveness of the treatment Problem-Solving Therapy for caregiver stress?

Research shows that Problem-Solving Therapy can effectively reduce anxiety, depression, and emotional distress in family caregivers, improving their overall well-being. This therapy has been successfully used in various settings, including for caregivers of cancer patients and stroke survivors, indicating its broad applicability and effectiveness. ^{1 2 3 4 5}

Is Problem-Solving Therapy safe for caregivers?

The research does not specifically mention any safety concerns related to Problem-Solving Therapy for caregivers, suggesting it is generally considered safe for use in humans. ^{1 2 3 4 6}

How is Problem-Solving Therapy different from other treatments for caregiver stress?

Problem-Solving Therapy is unique because it focuses on teaching caregivers how to effectively tackle and manage specific problems they face, which can reduce anxiety and depression. Unlike some treatments that may focus on emotional support, this therapy emphasizes practical problem-solving skills and can even be delivered over the phone, making it accessible and convenient for caregivers. ^{1 2 4 5 6}

Research Team

Karla Washington, Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Caring for family caregivers: An analysis of a family-centered intervention. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of problem solving technique applied by nurses: decreased anxiety and depression in family caregivers]. [2021]

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

Effectiveness of problem-solving technique in caring for family caregivers: a clinical trial study in an urban area of Catalonia (Spain). [2013]

4. England pubmed.ncbi.nlm.nih.gov

Delivering problem-solving therapy to family caregivers of people with cancer: A feasibility study in outpatient palliative care. [2019]

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

Telephone intervention with family caregivers of stroke survivors after rehabilitation. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

[Problem-solving counselling for caregivers of stroke survivors - an analysis of the addressed topics]. [2016]