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

Trial Summary

What is the purpose of this trial?

This trial aims to help older Veterans at risk for suicide by teaching them problem-solving skills and providing safety planning. The goal is to see if this method can better reduce suicidal thoughts and increase reasons for living.

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 data supports the effectiveness of the treatment Problem Solving Therapy for Suicide Prevention in Veterans?

Research shows that Problem Solving Therapy (PST) can significantly reduce suicidal thoughts and improve problem-solving skills in high-risk groups, including older adults and those with anxiety disorders. PST has also been found effective in reducing depression, which is often linked to suicide risk. ^{1 2 3 4 5}

Is Problem Solving Therapy (PST) safe for humans?

Problem Solving Therapy (PST) has been used safely in various studies to help reduce suicide risk, anxiety, and depression in older adults and Veterans. It is a non-drug therapy that focuses on improving problem-solving skills and has shown promise without significant safety concerns reported in the research. ^{1 2 3 4 6}

How is Problem Solving Therapy for Suicide Prevention (PST-SP) different from other treatments for preventing suicide in veterans?

Problem Solving Therapy for Suicide Prevention (PST-SP) is unique because it focuses on improving problem-solving skills and attitudes, which are often low in individuals vulnerable to suicide. Unlike other treatments, PST-SP is a structured, short-term therapy that includes training in positive problem orientation and all major problem-solving skills, making it particularly effective for veterans with traumatic brain injuries and feelings of hopelessness. ^{1 3 4 5 6}

Research Team

Sherry A Beaudreau, PhD

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. [2018]

2. United States 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. [2023]

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

A Case Report of Problem Solving Therapy for Reducing Suicide Risk in Older Adults with Anxiety Disorders. [2022]

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

Problem-solving therapy for suicide prevention in veterans with moderate-to-severe traumatic brain injury. [2022]

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

Problem-solving therapy for depression: a meta-analysis. [2022]

6. Hungary pubmed.ncbi.nlm.nih.gov

[An effective method of therapy in suicide prevention: problem solving training in the clinical population]. [2022]