Back to results

Improving Caregivers' Ability to Manage Life Stress

Primary Purpose

Suicidal Ideation

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Problem Solving Therapy (PST) plus EUC

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring caregiver, Cognitive Behavioral Therapy, suicidal ideation, suicide prevention, executive functioning, functional disability

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active treatment plus EUC

Arm Description

All caregivers are assigned to this condition and receive the treatment plus EUC.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05539352

First Posted

September 6, 2022

Last Updated

October 18, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05539352

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2, 2024 (Anticipated)

Primary Completion Date

March 31, 2026 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicidal Ideation

Keywords

caregiver, Cognitive Behavioral Therapy, suicidal ideation, suicide prevention, executive functioning, functional disability

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Masking Description

This is a single-arm pilot study with no random assignment to groups. No masking is applicable.

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active treatment plus EUC

Arm Type

Experimental

Arm Description

All caregivers are assigned to this condition and receive the treatment plus EUC.

Intervention Type

Behavioral

Intervention Name(s)

Problem Solving Therapy (PST) plus EUC

Other Intervention Name(s)

PST plus EUC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of recruitment and retention of participants

Description

Time Frame

At study completion, up to 41 months or completed participation of all participants, whichever came first

Title

Appropriateness of inclusion/exclusion criteria

Description

Time Frame

At study completion, up to 41 months or completed participation of all participants, whichever came first

Title

Acceptability of treatment

Description

Time Frame

At posttreatment (7 weeks)

Secondary Outcome Measure Information:

Title

Sensitivity of trial outcome measures

Description

Time Frame

Change from baseline to posttreatment (7 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherry A Beaudreau, PhD

Phone

(650) 493-5000

Ext

64119

Sherry.Beaudreau@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Julie A Lutz, PhD

Phone

(650) 493-5000

Julie.Lutz@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherry A Beaudreau, PhD

Organizational Affiliation

VA Palo Alto Health Care System, Palo Alto, CA

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System, Palo Alto, CA

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1207

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherry A Beaudreau, PhD

Phone

650-493-5000

Ext

64119

Sherry.Beaudreau@va.gov

First Name & Middle Initial & Last Name & Degree

Beatriz Hernandez, MS

First Name & Middle Initial & Last Name & Degree

Christine E Gould, PhD

First Name & Middle Initial & Last Name & Degree

Sherry A Beaudreau, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

A de-identified, anonymized dataset will be created and shared. The data set will be shared upon written request and will be shared pursuant to a Data Use Agreement (DUA) once the planned manuscripts have been accepted to peer-reviewed journals. At that time, the investigators will send researchers who have completed a DUA a electronic copy of the database in a password protected database file. Final datasets will be maintained locally until VA enterprise-level resources become available for long term storage and usage.

IPD Sharing 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 suicide prevention assessment and treatment.

IPD Sharing 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.

Learn more about this trial

Improving Caregivers' Ability to Manage Life Stress

We'll reach out to this number within 24 hrs