Problem Solving Therapy for Suicide Prevention in Veterans

Recruiting at 1 trial location

Overseen By Sherry A Beaudreau, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Antipsychotics for psychosis

Disqualifiers: Dementia, Bipolar, Severe OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 7 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to prevent suicide in older Veterans by testing Problem Solving Therapy (PST). It compares PST combined with usual care to usual care alone, which includes creating a suicide safety plan. The goal is to determine if PST can reduce suicide risk by addressing issues like functional disability (difficulty with daily tasks) and executive dysfunction (trouble with planning and organizing). Veterans aged 55 and older who have experienced suicidal thoughts in the past month and are dealing with depression, anxiety, or PTSD might be suitable candidates. As an unphased trial, this study offers Veterans the chance to contribute to important research that could enhance mental health care for others.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications, as long as they are not anti-psychotics prescribed for a psychotic disorder. Anti-psychotics for depression without psychosis and other psychotropic medications like SSRIs are allowed.

What prior data suggests that Problem Solving Therapy is safe for suicide prevention in older Veterans?

Research has shown that Problem Solving Therapy (PST) is generally safe and well-received. In previous studies, 75% of participants attended most of their PST sessions and reported high satisfaction. This therapy aims to lower the risk of suicide by teaching stress-coping strategies. Available data report no major negative effects from using PST, suggesting it is a safe option for older veterans at risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Problem Solving Therapy (PST) for suicide prevention in veterans because it offers a unique, structured approach to tackling the root causes of suicidal thoughts. Unlike traditional talk therapies that often focus on emotional exploration, PST helps individuals develop practical skills to address everyday problems effectively, potentially reducing feelings of helplessness. This hands-on technique empowers veterans to find solutions to their challenges, which could lead to a more immediate and tangible impact on their mental health. Combining PST with Enhanced Usual Care (EUC) may amplify these benefits by providing additional support and resources that veterans need.

What evidence suggests that Problem Solving Therapy might be an effective treatment for suicide prevention in Veterans?

Research has shown that Problem Solving Therapy (PST), which participants in this trial may receive alongside Enhanced Usual Care (EUC), can help lower the risk of suicide in older Veterans. Studies have found that PST improves emotional stress management by teaching individuals how to handle challenging situations. In earlier small studies, participants expressed high satisfaction with PST and attended most sessions. PST has also been shown to address issues like difficulty in daily activities and problems with thinking and planning, which are key risk factors for suicide. These findings suggest that PST could be a promising method to prevent suicide in older Veterans at risk. ^{1 2 4 5 6}

Who Is on the Research Team?

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 older Veterans (60+) with depression, anxiety, PTSD or similar conditions who have had suicidal thoughts but are not at imminent risk. They must be able to understand English and participate in therapy without severe cognitive impairment from dementia or recent head injury. Those with certain psychiatric disorders, substance abuse issues, unstable medical conditions, or currently in individual psychotherapy are excluded.

Inclusion Criteria

Eligibility now includes non-specific active suicidal thoughts to active SI with some planning (on C-SSRS item 3: 'Have you been thinking about how you might do this') and/or some intent to act (on C-SSRS item 4: 'Have you had these thoughts and had some intention of acting on them?') provided that those endorsing item 4 have an established relationship with a psychiatrist aware of this intent level (who is not also performing psychotherapy)

I am not currently taking anti-psychotics for a psychotic disorder.

I am taking anti-psychotics for depression without having psychosis.

Exclusion Criteria

I have been diagnosed with severe OCD, bipolar disorder, or have psychotic symptoms.

AUDIT Total score >14 for men or >12 for women (no current alcohol use disorder)

I am currently taking anti-psychotics for a psychotic disorder, not just for depression.

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 (PST) plus Enhanced Usual Care (EUC) or EUC only, delivered in six weekly sessions

7 weeks

6 visits (phone)

Follow-up

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

6 months

3 visits (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care (EUC)
• Problem Solving Therapy (PST) plus EUC

Trial Overview The study compares usual VA care for suicide prevention with an addition of Problem Solving Therapy (PST) to see if it better reduces suicide risk among older Veterans. PST aims to improve coping strategies and has shown promise in pilot studies for reducing late-life suicide risk.

How Is the Trial Designed?

Group I: Active treatment plus EUC Experimental Treatment 1 Intervention

Veterans randomized to this condition received the treatment plus EUC.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Active comparator (EUC only).

Problem Solving Therapy (PST) plus EUC is already approved in United States, European Union for the following indications:

Approved in United States as Problem Solving Therapy for:

• Suicide prevention in older adults
• Late-life depression
• Functional disability
• Executive dysfunction

Approved in European Union as Problem Solving Therapy for:

• Suicide prevention
• Depression
• Anxiety disorders

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Problem-solving therapy (PST) was effective in reducing suicide risk in two older adults with anxiety disorders, demonstrating its potential as a treatment option for this population.

Both individuals showed significant decreases in anxiety, worry, and depressive symptoms after completing six sessions of PST, suggesting that this therapy can improve overall mental health in older adults at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report of Problem Solving Therapy for Reducing Suicide Risk in Older Adults with Anxiety Disorders. Lutz, J., Mashal, N., Kramer, A., et al.[2022]

Problem-Solving Therapy for Suicide Prevention (PST-SP) was found to be acceptable and feasible for 16 U.S. Veterans with moderate-to-severe traumatic brain injury (TBI) and hopelessness, with 75% attending at least 80% of the sessions.

Participants reported high satisfaction with PST-SP, indicating it was valuable and beneficial without negative effects, which supports further testing of its efficacy in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving therapy for suicide prevention in veterans with moderate-to-severe traumatic brain injury. Barnes, SM., Monteith, LL., Gerard, GR., et al.[2022]

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]

In a pilot study involving 34 participants with a history of suicide attempts or depression, Problem Solving Training (PST) significantly reduced levels of depression and hopelessness after eight weeks of therapy.

PST also improved participants' problem-solving skills and goal orientation, suggesting it is an effective method for suicide prevention in both outpatient and inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An effective method of therapy in suicide prevention: problem solving training in the clinical population]. Ajtay, G., Bérdi, M., Szilágyi, S., et al.[2022]

Cognitive behavior therapy (CBT) and problem-solving therapy (PST) both led to significant improvements in various measures related to hopelessness and suicidal ideation among suicide attempters, indicating their efficacy as treatment options.

Participants receiving CBT and PST reported higher satisfaction levels compared to those receiving treatment as usual (TAU), highlighting the potential benefits of these brief therapies in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. Stewart, CD., Quinn, A., Plever, S., et al.[2018]

This clinical trial will evaluate the effectiveness of an updated version of Problem Solving Therapy (emotion-centered PST) combined with enhanced usual care (EUC) in reducing suicidal ideation among 150 older Veterans with active suicidal thoughts, compared to EUC alone.

The study aims to assess changes in suicidal ideation and reasons for living over multiple time points, providing insights into how effective EC-PST is in improving coping skills and potentially informing future clinical guidelines for suicide prevention in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond maintaining safety: Examining the benefit of emotion-centered problem solving therapy added to safety planning for reducing late life suicide risk. Beaudreau, SA., Lutz, J., Wetherell, JL., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28795831/

Problem-solving therapy for suicide prevention in veterans ... 75% (n = 12) of participants enrolled in the pilot study attended ≥80% of PST-SP sessions. Participants reported high satisfaction with PST-SP ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04763330

Reducing Suicide Risk in Older Veterans Using Problem ... The randomized control trial will compare VA usual care, which is suicide safety planning, with brief Problem Solving Therapy and suicide safety planning.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000708

Examining the benefit of emotion-centered problem solving ... PST may reduce suicide risk in older Veterans by helping them manage psychological distress through improved adaptive coping with stressful problems [15]. Poor ...

4. mirecc.va.gov mirecc.va.gov/visn19/treatmentworksforvets/suicide-prevention/index.asp

Learn About Proven Suicide Prevention Options Problem Solving Therapy for Suicide Prevention (PST-SP) is an evidence-based talk therapy that is effective for helping prevent suicide attempts ...

5. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-9-2021-545ef

Problem Solving Therapy for Suicide Prevention in Veterans Problem-solving therapy (PST) was effective in reducing suicide risk in two older adults with anxiety disorders, demonstrating its potential as a treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164054/

Examining the benefit of emotion-centered problem solving ... Ultimately, the goal of this study is to inform the evidence-based clinical practice guidelines for treatments to reduce suicide risk in older Veterans and ...