Clinical trial NCT05539352: Improving Caregivers' Ability to Manage Life Stress
Official title: Reducing Suicide Risk in Older Veterans With Mental Health Disorders Using Problem Solving Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Suicidal Ideation
Keywords: caregiver
Cognitive Behavioral Therapy
suicidal ideation
suicide prevention
executive functioning
functional disability
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a single arm, receiving PST+EUC. Both parts of the treatment are evidence-based interventions, and the treatment protocol is delivered in six sessions. The study will occur at VA Palo Alto.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The proposed single-arm pilot will examine the feasibility and acceptability of a brief behavioral treatment for reducing suicidal ideation and for increasing reasons for living in caregivers of Veterans with dementia. 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 also be included in the treatment protocol, herein referred to as enhanced usual care (EUC). For participant safety, all caregivers will receive both PST and EUC. The study design is a single arm. Both PST and EUC are evidence-based interventions, and the treatment is delivered in six sessions. The study will occur at VA Palo Alto.

The assessments and treatments will be conducted entirely by video. Participants will be sent VA-approved tablets. 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 10 caregivers. Caregivers must be 50 years or older and report suicide ideation to be eligible. Veterans will be excluded and referred for other services if they have psychotic symptoms, bipolar disorder, or severe OCD; an alcohol/substance use disorder; severe or unstable medical conditions; recent head injury (past year) or history of a head injury with loss of consciousness for 24 or more hours; 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 10 caregivers.

Eligibility criteria: Inclusion Criteria:

* 50 years old or older
* Identify as a informal caregiver to at least 1 older Veteran
* SI (past month) on the C-SSRS. No SI or imminent risk (will be excluded). Eligibility 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. No suicide attempt in the past 3 months.
* 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 or no lifetime history of head injury with LOC \> 24 hours
* No severe or unstable chronic medical illness or other severe or unstable respiratory, cardiovascular, neurologic, hepatic, hematopoietic, gastrointestinal or metabolic dysfunction
* AUDIT Total cut-off scores for inclusion of 14 or lower for men, and 12 or lower for women (no current alcohol use disorder)
* 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 psychotherapy for a mental health issue (see details below in Exclusion Criteria)
* 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. Medication changes are allowed after study enrollment
* Participants must not meet criteria for any substance use disorder for illicit substances, as determined by the MINI. Further, participants must not meet criteria for moderate or severe substance use disorder for cannabis/marijuana (mild substance use disorder may be included)

  * Access to internet connection in a private area (e.g., own or other's home, office, etc.) to engage in private online treatment sessions by video. Does not need video/internet-enabled device (study will provide a tablet), just access to internet

Exclusion Criteria:

* Less than 50 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. Exclude if there is a suicide attempt in the past 3 months
* 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 or lifetime history of head injury with LOC \> 24 hours
* Severe or unstable chronic medical illness or other severe or unstable respiratory, cardiovascular, neurologic, hepatic, hematopoietic, gastrointestinal or metabolic dysfunction
* AUDIT Total cut-off scores for exclusion to scores of 15 or higher for men, and 13 or higher for women (no current alcohol use disorder)
* 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 psychotherapy for a mental health issue: Participants will be excluded if they are currently enrolled in some other individual psychotherapy or evidence-based group therapy (e.g., cognitive behavioral therapy for depression), but the participant would be eligible for the study after they complete their treatment if they still have suicidal ideation. 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. Once enrolled in the study, unless there is an unanticipated contraindication to continue the participant in the study while they are receiving other mental health care, they will be retained in the study. Participants will stop study treatment if there is any contraindication to continue the participant in the study while they are receiving new mental health treatment outside of the study.
* Current prescription for anti-psychotics
* Individuals who meet criteria for any substance use disorder for illicit substances or for moderate or severe substance use disorder for cannabis/marijuana will be excluded

  * Lack of access to internet connection in a private area (e.g., own or other's home, office, etc.); inability to engage in private online treatment sessions by video

Primary outcomes:
measure: Feasibility of recruitment and retention of participants
timeFrame: At study completion, up to 41 months or completed participation of all participants, whichever came first
measure: Appropriateness of inclusion/exclusion criteria
timeFrame: At study completion, up to 41 months or completed participation of all participants, whichever came first
measure: Acceptability of treatment
timeFrame: At posttreatment (7 weeks)
Secondary outcomes:
measure: Sensitivity of trial outcome measures
timeFrame: Change from baseline to posttreatment (7 weeks)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Sherry A Beaudreau, PhD
role: PRINCIPAL_INVESTIGATOR
References: