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PST + EUC for Managing Caregiver Stress

SA
JA
CE
Overseen ByChristine E Gould, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Problem-Solving Therapy (PST), delivered via video, can reduce suicide risk in caregivers of Veterans with dementia. The research examines how this therapy might alleviate the stress and mental health challenges caregivers face, especially as the COVID-19 pandemic has increased their caregiving demands. This study may suit individuals who are 50 or older, care for a Veteran with dementia, and have experienced thoughts of suicide in the past month. Participants should not have dementia themselves and must have internet access to join the therapy sessions online. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance mental health support for caregivers.

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

The trial does not require you to stop your current medications. You can continue taking medications like SSRIs (a type of antidepressant) and anti-psychotics if they are prescribed for depression without psychosis. Medication changes are allowed after you join the study.

What prior data suggests that Problem Solving Therapy is safe for caregivers of Veterans with dementia?

Research has shown that Problem Solving Therapy (PST) is generally safe and well-tolerated. Many studies have examined its use for different groups, including caregivers and people with mental health issues, and no reports of serious side effects have emerged.

PST, a type of cognitive-behavioral therapy, helps people manage stress by teaching effective problem-solving skills. It has been used in various settings, such as doctor's offices and hospice care, without major safety concerns.

For those considering joining a clinical trial for PST, research suggests it is a safe choice. However, individual experiences may vary, so discussing any concerns with a healthcare provider is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about Problem Solving Therapy (PST) for managing caregiver stress because it offers a proactive approach that equips caregivers with practical skills to tackle daily challenges. Unlike many traditional treatments that primarily focus on emotional support or medication to manage stress, PST empowers caregivers by enhancing their problem-solving abilities. This method not only addresses current stressors but also builds resilience by helping caregivers develop strategies to effectively manage future problems. The inclusion of Enhanced Usual Care (EUC) ensures that caregivers continue to receive comprehensive support, making this approach a holistic option that could potentially improve caregivers' quality of life significantly.

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

Research has shown that Problem Solving Therapy (PST), which participants in this trial will receive, effectively reduces depression symptoms in caregivers, particularly those caring for individuals with early dementia. Studies have found that PST decreases stress and enhances problem-solving skills among family caregivers. It also improves mental health, daily functioning, and overall quality of life. Additionally, PST has proven effective in reducing anxiety and depression symptoms in older adults. These findings suggest that PST could help manage stress and lower the risk of suicide in dementia caregivers during challenging times, such as the COVID-19 pandemic.16789

Who Is on the Research Team?

SA

Sherry A Beaudreau, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for caregivers over 50 years old who look after a Veteran and have had suicidal thoughts in the past month but are not at immediate risk. They must be able to use the internet for video sessions, not have dementia or severe mental health issues like psychosis, bipolar disorder, or severe OCD. They should also not have recent head injuries, unstable chronic illnesses, or substance abuse problems.

Inclusion Criteria

I have not been diagnosed with severe mental health disorders like psychosis, bipolar, or severe OCD.
I am not currently taking anti-psychotics for a psychotic disorder.
No prominent homicidal ideation
See 14 more

Exclusion Criteria

My senses are not good enough for tests or treatment.
I have had a severe head injury or one in the past year.
AUDIT Total cut-off scores for exclusion
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Problem Solving Therapy and Enhanced Usual Care over six weekly sessions

6 weeks
6 visits (virtual)

Post-treatment Assessment

Assessment of suicidal ideation and reasons for living immediately after treatment

1 week
1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 1-, 3-, and 6-month intervals

6 months
3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Problem Solving Therapy (PST)
Trial Overview The study tests Problem-Solving Therapy delivered via video to reduce suicide risk among caregivers of Veterans with dementia during COVID-19. It aims to see if this approach is practical and well-received by participants.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Active treatment plus EUCExperimental Treatment1 Intervention

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

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Approved in United States as Problem-Solving Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

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 ...
Evaluation of a problem-solving (PS) techniques-based ...Results showed that PST training is indeed effective in alleviating distress and in decreasing dysfunctional problem solving (PS) styles among family carers of ...
Effectiveness of Problem-Solving Therapy in Improving ...This systematic review assessed the effectiveness of PST in improving mental health, functioning, quality of life, and mortality in this population.
A Problem Solving Intervention for Hospice CaregiversThe intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. Participant Group/ ...
Application of Problem Solving Therapy for Late-Life AnxietyFor example, applied relaxation, problem-solving training, and cognitive therapy have been shown to be clinically effective in reducing symptoms of GAD and MDD ...
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.
A Problem Solving Intervention for Hospice CaregiversThe intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients. Participant Group/ ...
Supporting Family Caregivers in Providing Care - NCBI - NIHResearch supporting this caregiver-as-client perspective focuses on ways to protect family caregivers' health and safety.
Bilingual problem-solving training for caregivers of adults ...These results will establish guidelines needed for an evidence-based, culturally-adapted, and implementable problem-solving intervention to reduce caregiver ...
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