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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
All caregivers are assigned to this condition and receive EUC and PST. EUC is delivered along with the treatment to ensure the safety of all caregivers enrolled in the study. In addition to EUC, caregivers 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 caregivers and active suicidal ideation: emotion dysregulation, hopelessness, and feeling overwhelmed by too much information ("brain overload") or stress.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Feasibility of recruitment and retention of participants
The investigators will estimate the rate of recruitment during the course of the study, to inform feasible recruitment rates for future clinical trials with this population. Feasibility of retention will be established if 80% or more of enrolled participants are retained for at least 5 of 6 treatment sessions.
Time frame: At study completion, up to 41 months or completed participation of all participants, whichever came first
Appropriateness of inclusion/exclusion criteria
Appropriateness of the inclusion/exclusion criteria will be determined by examining frequency tables and/or qualitative data indicating number and types of reasons for screening failures and withdrawals from the treatment/study. These frequency tables will inform decisions in future research regarding modifications to inclusion/exclusion criteria.
Time frame: At study completion, up to 41 months or completed participation of all participants, whichever came first
Acceptability of treatment
Acceptability of the treatment will be determined based on adherence in attending sessions and completing homework, and treatment satisfaction ratings. A threshold of 80% or more (5 out of 6 sessions attended; 4 or more with completed homework \[no homework in first session\]), based on the rates reported for other late-life behavioral intervention studies, will be used to establish adherence. Mean ratings of 3 ("good/helpful") or higher on a 5-point item assessing how effective the treatment was in helping participants to deal better with their problems, and mean ratings of 3 ("somewhat met my expectations") or higher on a 4-point item assessing how well the treatment met their expectations, will be used to establish treatment satisfaction. Treatment expectations, likes, and dislikes will be analyzed by identifying themes of patient responses and tallying them in a frequency table for review. This will help determine if certain aspects of the treatments should be retained or modified.
Time frame: At posttreatment (7 weeks)
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Sensitivity of trial outcome measures
Sensitivity of the potential outcome measures for future randomized clinical trials will be determined. Mean pre- and post-scores will be compared using t-tests to determine the direction of change on the following measures: Geriatric Suicide Ideation Scale (GSIS), Reasons for Living - Older Adults Scale (Short RFL-OA), WHO Disability Assessment Schedule (WHO-DAS 2.0) short form, DKEFS Verbal Fluency Test, WAIS Digit Span subtest (Digits Forward and Backward), Oral Trail Making Test.
Time frame: Change from baseline to posttreatment (7 weeks)