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Caregiver SOS Program for Caregiver Stress (Caregiver SOS Trial)

N/A
Recruiting
Led By Amy W Helstrom, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veteran has a confirmed diagnosis of depressive disorder, generalized anxiety disorder, PTSD, and/or TBI (per medical chart/provider report)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Caregiver SOS Trial Summary

This trial is testing whether a program that helps caregivers manage their stress will improve the caregivers' wellbeing, work functioning, and the quality of care for the person they are caring for.

Who is the study for?
This trial is for employed caregivers who assist a family member or friend with daily tasks and experience moderate work difficulty due to caregiving. Participants must be caring for a veteran with mental health issues, be over 18, and able to consent. Caregivers unable to speak English or with impairments affecting participation are excluded.Check my eligibility
What is being tested?
The study tests 'Caregiver SOS', a phone-based counseling program aimed at helping caregivers manage stress related to balancing work and their caregiving role. It focuses on improving the caregiver's wellbeing, job performance, productivity, and quality of care provided.See study design
What are the potential side effects?
Since 'Caregiver SOS' is a counseling intervention rather than a medication, it may not have typical side effects but could potentially lead to emotional discomfort or increased stress if discussions trigger sensitive topics.

Caregiver SOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran diagnosed with depression, anxiety, PTSD, or TBI.

Caregiver SOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
10-item Kessler Psychological Distress Scale (K10)
Secondary outcome measures
Caregiver Work Limitations Questionnaire (C-WLQ)

Caregiver SOS Trial Design

2Treatment groups
Active Control
Group I: Caregiver SOSActive Control1 Intervention
SOS care is brief, telephonic care (6 one-hour sessions over 3-4 months) tailored to the CG's needs, preferences, and priorities. SOS care addresses both work and caregiving-related stress. The five pillars of behavior change in SOS care are: 1) knowledge of work and CG stress; 2) stress management skills and abilities; 3) supports and resources; 4) confidence and motivation to modify stress; and 5) work and CG-focused problem-solving skills. The pillars are addressed through seven modules. In six sessions, the CM will cover each module at least once. SOS care involves an ongoing process of formulating self-management goals and action plans and preparing CGs to succeed in implementing them. Addressing both work and caregiving contexts, CMs will educate CGs about stress. CMs introduce strategies for self-managing stress and collaboratively design experiments to test these strategies. The CG's progress is monitored to identify strategies that effectively achieve self management goals.
Group II: Usual CareActive Control1 Intervention
CGs in this arm will be contacted telephonically once by a CM. After a brief needs assessment, the CM will provide contact information for appropriate VA (e.g., local CSP clinicians) and non-VA community resources/services. CGs will be sent brochures for the national VA CSP. Information on both the program's website (which includes links to training, education, resources, and outreach programs for CGs) and the national CG hotline number will be included in the mailed packet. After this initial contact, CGs in this group will only be contacted again 4 and 9 months after baseline for administration of follow-up research assessments. CGs will be encouraged to seek medical, psychological, social support, and social services that are available to them through VAMCs or any other non-VA/community source. CGs in the SOS group will be offered similar information.

Find a Location

Who is running the clinical trial?

The VA Western New York Healthcare SystemFED
7 Previous Clinical Trials
670 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,806 Total Patients Enrolled
Amy W Helstrom, PhDPrincipal InvestigatorCorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Media Library

Caregiver SOS Clinical Trial Eligibility Overview. Trial Name: NCT04337021 — N/A
Job Stress Research Study Groups: Caregiver SOS, Usual Care
Job Stress Clinical Trial 2023: Caregiver SOS Highlights & Side Effects. Trial Name: NCT04337021 — N/A
Caregiver SOS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04337021 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this research endeavor?

"Affirmative, according to clinicaltrials.gov the trial is presently recruiting participants. The posting of this study was originally on December 28th 2020 and it has been recently modified as of November 16th 2022. 300 individuals need to be recruited from 2 medical centres."

Answered by AI

Are there any open enrolment slots for this clinical investigation?

"This medical study is actively enrolling participants. It was initially posted on December 28th 2020, and the details were recently updated on November 16th 2022 according to clinicaltrials.gov."

Answered by AI
~0 spots leftby Mar 2024