Clinical trial NCT04763330: Reducing Suicide Risk in Older Veterans Using Problem Solving Therapy
Official title: Reducing Suicide Risk in Older Veterans With Mental Health Disorders Using Problem Solving Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: The proposed randomized control trial will examine the efficacy of a brief behavioral treatment for reducing suicidal ideation and for increasing reasons for living in older Veterans at risk for suicide. Two common issues in older adults, functional disability and executive dysfunction, increase suicide risk and will be examined as moderators and mediators of treatment outcomes. The proposed study will examine Problem Solving Therapy (PST) using a protocol that teaches skills to address emotional and practical barriers to effective problem solving. The VA usual care practice of collaborative safety planning will be the control condition, herein referred to as enhanced usual care (EUC). For participant safety, Veterans enrolled in PST will also receive EUC. 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).

The assessments and treatments will be conducted entirely by phone. Longitudinal assessment of suicidal ideation and reasons for living will occur at eleven timepoints: baseline, after each of the six weekly treatment sessions, posttreatment (7 weeks), at 1-, 3-, and 6-month follow-up. The recruitment goal is 150 Veterans over a five-year period with 75 participants randomized to each treatment. Veterans must be 60 years or older, report suicide ideation, and meet diagnostic criteria for a depressive disorder, anxiety disorder, and/or posttraumatic stress disorder to be eligible. Veterans will be excluded and referred for other services if they have psychotic symptoms, bipolar disorder, or severe OCD; certain alcohol/substance use disorders; severe or unstable medical conditions; recent head injury (past year); terminal illness; positive cognitive screen indicative of possible dementia; or if they are unable to participate in the study or follow-up sessions. Recruitment will occur through multiple strategies at VA, Vet centers, and in the community to ensure the feasibility of recruiting a total of 75 Veterans at each site. To meet this recruitment goal, the primary and secondary site will each enroll 2 to 3 Veterans per month.

Fidelity ratings of audiotaped treatment sessions will be made by independent raters on 20% of sessions. Mixed effects modeling will be used to estimate the effect of treatment versus the control for the outcomes of suicidal ideation and reasons for living. Models will covary for demographics, medical and psychiatric comorbidity, and psychotropic use. For the primary aim, models will determine whether PST plus EUC is associated with a larger treatment effect compared with EUC only for suicidal ideation and reasons for living. Secondary aims will determine if baseline functional disability and executive dysfunction moderate treatment outcomes, and whether a change in these two variables from baseline to posttreatment are significantly associated with (mediate) change in suicidal ideation and reasons for living. The tertiary aims will use qualitative methods to assess Veteran satisfaction with the treatment and control including the types of problems with which treatment helped them, and suggestions for improving it for future Veterans. The current VA/DoD Clinical Practice Guidelines (CPGs) for suicide do not list treatment options specifically for older Veterans despite the majority of VHA patients being 55 years or older. Thus, evidence-based outcomes from the proposed work have potential to inform the CPG recommendations for using PST with Safety Planning and/or Safety Planning alone with older Veterans. Dissemination of the treatment could be supported by expanding existing VA training infrastructure in problem solving based interventions.

Eligibility criteria: Inclusion Criteria:

* \>= 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
* Not 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.
* No current prescription for anti-psychotics if prescribed for a psychotic disorder

  * Anti-psychotics for depression without psychosis are eligible
  * Psychotropic medications (e.g., SSRIs) are also eligible

Exclusion Criteria:

* \< 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

Primary outcomes:
measure: Geriatric Suicide Ideation Scale (GSIS)
timeFrame: Change across 11 timepoints: baseline, after each of the 6 weekly treatment sessions, posttreatment (7 weeks), 1-, 3-, and 6-month follow-up.
measure: Reasons for Living - Older Adult Scale (Short RFL-OA)
timeFrame: 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:
measure: WHO Disability Assessment Schedule (WHO-DAS 2.0) short form
timeFrame: Change from baseline to posttreatment (7 weeks).
measure: DKEFS Verbal Fluency Test
timeFrame: Baseline
measure: WAIS Digit Span subtest (Digits Forward and Backward)
timeFrame: Baseline
measure: DKEFS Verbal Fluency Test
timeFrame: Change from baseline to posttreatment (7 weeks)
measure: Oral Trail Making Test (OTMT)
timeFrame: Baseline
measure: WAIS Digit Span subtest (Digits Forward and Backward)
timeFrame: Change from baseline to posttreatment (7 weeks)
measure: Oral Trail Making Test (OTMT)
timeFrame: Change from baseline to posttreatment (7 weeks)
Other outcomes:
measure: Suicide attempts
timeFrame: Within the 12-months post-treatment
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Sherry A Beaudreau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.