Reducing Suicide Risk in Older Veterans Using Problem Solving Therapy

NCT04763330 | Terminated DMC

• 1 other identifier: MHBC-003-20S
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief Summary

Suicide is a national crisis, especially among older Veterans for whom evidence-based suicide prevention efforts are lacking. This proposal responds to the national priority to develop and improve interventions for suicide prevention, with a focus on at-risk older Veterans. The randomized control trial will compare VA usual care, which is suicide safety planning, with brief Problem Solving Therapy and suicide safety planning. This study uses Problem Solving Therapy because it has support from our pilot data and from secondary data analysis from other studies for reducing late life suicide risk. This treatment also has support for alleviating two key risk factors for late life suicide risk, functional disability and executive dysfunction, and thus this study will examine how older Veterans with varying levels of functional disability and executive functioning respond to treatment to inform future targeted implementation. In accordance with national priorities, existing infrastructure in Problem Solving Training could be expanded to support more rapid VA-wide implementation.

Conditions

Suicidal Ideation; Depressive Disorder; Anxiety Disorders; Post Traumatic Stress Disorder

Keywords

older adult; Cognitive Behavioral Therapy; suicidal ideation; suicide prevention; executive functioning; functional disability

Outcome Measures

Primary Outcomes (2)

• Geriatric Suicide Ideation Scale (GSIS)

  Geriatric Suicide Ideation Scale (GSIS) will assess SI over time. This 31-item self-report measure has four factors (suicide ideation, death ideation, loss of personal and social worth, and perceived meaning in life). The total score will serve as the outcome measure. Total scores range from 31 to 155. Higher scores indicate greater severity of suicide-related thinking. Internal consistency is excellent ( alpha = .90), with strong test-retest reliability (r = .86 over 1- to 2-month period). Construct and discriminant validity have been established. The GSIS will be administered at 11 timepoints: baseline, after each of the 6 weekly treatment sessions, posttreatment (7 weeks), 1-, 3-, and 6-month follow-up.

  Change across 11 timepoints: baseline, after each of the 6 weekly treatment sessions, posttreatment (7 weeks), 1-, 3-, and 6-month follow-up.

• Reasons for Living - Older Adult Scale (Short RFL-OA)

  Reasons for Living - Older Adult Scale (Short RFL-OA) is a 30-item questionnaire of positive attitudes, coping ability, \& religious and family RFL. Items include areas of importance to older populations, (e.g., family reasons). The total score will be the outcome measure. Total scores range from 30 to 180, with higher scores indicating that one places greater importance on different protective factors for not trying to kill oneself by suicide. Internal consistency is excellent (alpha = .94). Construct validity is established in older adults. The RFL-OA will be administered at 11 timepoints: baseline, after each of the 6 weekly treatment sessions, posttreatment (7 weeks), 1-, 3-, and 6-month follow-up.

  Change across 11 timepoints: baseline, after each of the 6 weekly treatment sessions, posttreatment (7 weeks), 1-, 3-, and 6-month follow-up.

Secondary Outcomes (7)

• WHO Disability Assessment Schedule (WHO-DAS 2.0) short form

  Change from baseline to posttreatment (7 weeks).

• DKEFS Verbal Fluency Test

  Baseline

• WAIS Digit Span subtest (Digits Forward and Backward)

  Baseline

• DKEFS Verbal Fluency Test

  Change from baseline to posttreatment (7 weeks)

• Oral Trail Making Test (OTMT)

  Baseline

Other Outcomes (1)

• Suicide attempts

  Within the 12-months post-treatment

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Active comparator (EUC only).

Behavioral: Enhanced Usual Care (EUC)

Active treatment plus EUC

EXPERIMENTAL

Veterans randomized to this condition received the treatment plus EUC.

Behavioral: Problem Solving Therapy (PST) plus EUC

Interventions

Enhanced Usual Care (EUC) BEHAVIORAL

Enhanced Usual Care (EUC) consists of Collaborative Safety Planning, a VA usual care practice. It is a tool that Veterans can use when they are in an acute suicidal crisis. The condition is considered enhanced because Veterans in this condition receive 6 sessions total, Safety Planning which is delivered in 1-2 sessions and 4-5 sessions of check-ins with a brief assessment. Safety Planning involves a worksheet completed by the patient in collaboration with a health provider.

Also known as: VA Safety Planning

Enhanced Usual Care (EUC)

Problem Solving Therapy (PST) plus EUC BEHAVIORAL

Veterans randomized to this condition received EUC and PST. EUC is delivered in both conditions to ensure the safety of all Veterans enrolled in the study. In addition to EUC, Veterans in this condition receive PST, which teaches patients a structured "planful problem solving" approach to: 1) identify problems and set goals, 2) generate alternative solutions, 3) select a solution based on cost-benefit analysis, and 4) devise and implement a plan for the solution and assess its effectiveness in solving the problem. This contemporary PST protocol also teaches tool kits to address obstacles highly pertinent to the challenges faced by older Veterans with mental health disorders and active suicidal ideation: emotion dysregulation, hopelessness, and feeling overwhelmed by too much information ("brain overload") or stress.

Also known as: PST plus EUC

Active treatment plus EUC

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 55 years old
• SI (past month) on the C-SSRS
• No SI or imminent risk (will be excluded)
• 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)
• Those endorsing C-SSRS item 5: "Do you intend to carry out this plan?" would be considered at imminent risk and excluded
• Presence of DSM-5 depressive disorder or anxiety disorder, specified or unspecified, or PTSD or subthreshold PTSD.
• No diagnosis of dementia; evidence that cognitive impairment is not indicative of possible dementia based on a negative cognitive telephone screen (\<10 errors on the Blessed cognitive screen)
• No diagnosis on MINI or medical record for psychotic symptoms or disorders, bipolar disorder, or severe OCD (mild or moderate OCD will be eligible)
• No history of head injury past 12 months
• No severe or unstable chronic medical illness or other severe or unstable respiratory, cardiovascular, neurologic, hepatic, hematopoietic, gastrointestinal or metabolic dysfunction
• AUDIT Total score \<15 for men or \<13 for women (no current alcohol use disorder)
• No substance use disorder of any type for illicit substances, no moderate or severe substance use disorder for cannabis/marijuana - on the MINI.
• No prominent homicidal ideation
• English language proficiency to engage in treatment
• Sensory abilities sufficiently intact to engage in assessment and treatment

You may not qualify if:

• \< 55 years old
• No SI (past month) or imminent risk on the C-SSRS will be excluded. Those endorsing C-SSRS item 5: "Do you intend to carry out this plan?" would be considered at imminent risk and excluded
• No DSM-5 depressive disorder or anxiety disorder, or PTSD or subthreshold PTSD
• Diagnosis of dementia; evidence that cognitive impairment is indicative of possible dementia based on a positive cognitive telephone screen (\>=10 errors on the Blessed cognitive screen)
• Diagnosis on MINI or medical record for psychotic symptoms or disorders, bipolar disorder, or severe OCD (mild or moderate OCD will be eligible)
• History of head injury past 12 months
• Severe or unstable chronic medical illness or other severe or unstable respiratory, cardiovascular, neurologic, hepatic, hematopoietic, gastrointestinal or metabolic dysfunction
• AUDIT Total score \>14 for men or \>12 for women (no current alcohol use disorder)
• Substance use disorder of any type for illicit substances, moderate or severe substance use disorder for cannabis/marijuana - on the MINI.
• Prominent homicidal ideation
• Lacking English language proficiency to engage in treatment
• Sensory abilities not sufficiently intact to engage in assessment and treatment
• Currently enrolled in individual psychotherapy for a mental health issue. Participants who are receiving mental health care are eligible if their current care includes treatment from a psychiatrist, supportive therapy, peer counseling or support, or participating in psychoeducational groups.
• Current prescription for anti-psychotics if prescribed for a psychotic disorder, and not prescribed for depression without psychosis

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Related Publications (1)

• Beaudreau SA, Lutz J, Wetherell JL, Nezu AM, Nezu CM, O'Hara R, Gould CE, Roelk B, Jo B, Hernandez B, Samarina V, Otero MC, Gallagher A, Hirsch J, Funderburk J, Pigeon WR. Beyond maintaining safety: Examining the benefit of emotion-centered problem solving therapy added to safety planning for reducing late life suicide risk. Contemp Clin Trials. 2023 May;128:107147. doi: 10.1016/j.cct.2023.107147. Epub 2023 Mar 14.

  PMID: 36921689 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Depressive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Sherry A Beaudreau, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant's assignment to treatment will not be shared with the outcomes assessor. A "randomizer" will provide treatment assignment to the participant after the assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study design is random assignment to the treatment, PST plus EUC, or the control condition, EUC only. Both the treatment and the control are evidence-based interventions delivered in six sessions. The study will occur at VA Palo Alto (primary site) and VA Syracuse/VA Canandaigua (secondary site).

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 21, 2021
• Study Start: January 24, 2022
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Publications from this project will be made available through the National library of Medicine PubMed Central website 1 year of the date of publication. The final de-identified datasets underlying these publications will be available by written request to the PD/PI. Data will be available by written request until March 31, 2046. This date will be extended if it is determined that availability of the data to researchers would be in the interest of the scientific literature on suicide prevention, or if additional research questions can be developed the data to address important gaps in late life suicide prevention assessment and treatment.
• Access Criteria: Protection of privacy, confidentiality, and proprietary data is ensured using the following mechanisms: 1) a de-identified dataset, 2) signed data user agreement that will prohibit researchers requesting the data from identifying or attempting to re-identify individuals in the dataset ,3) "90+" age category, but not an exact age for adults aged 90 years or older to prevent identification, 4) sharing only of quantitative data, but not qualitative data to further prevent identification.

Locations

US (2)