PST + EUC for Managing Caregiver Stress

Overseen By Julie A Lutz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Antipsychotics

Disqualifiers: Dementia, Psychotic disorders, Bipolar, 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: 10

Duration: 6 weeks

Trial Summary

What is the purpose of this trial?

The COVID-19 pandemic has led to increased caregiving demands for caregivers of Veterans with dementia. Dementia caregivers are particularly at-risk for depression and anxiety, known risk factors for increased suicidality. Emerging research also suggests that dementia caregivers are experiencing greater suicidality during COVID-19 at a time when VHA is also devoting increased efforts toward caregiver health and support services. Aims are to determine the feasibility and acceptability of video-delivered Problem-Solving Therapy for reducing suicide risk in caregivers of Veterans with dementia.

Research Team

Sherry A Beaudreau, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Active treatment plus EUC Experimental Treatment 1 Intervention

All caregivers are assigned to this condition and receive the treatment plus EUC.

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?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+