N/A
N=199
Caregiver Self-Management of Stress
Caregiver Distress · Job Stress
Bottom Line
View on ClinicalTrials.gov: NCT04337021 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: 10-item Kessler Psychological Distress Scale (K10) — 23.38; 23.79 score on a scale — p=0.513
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caregiver SOS (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10-item Kessler Psychological Distress Scale (K10) |
23.38; 23.79 | 0.513 |
| PRIMARY Caregiver Work Limitations Questionnaire (C-WLQ) - Mental |
62.15; 59.71 | .184 |
| PRIMARY Caregiver Work Limitations Questionnaire (C-WLQ) - Physical |
30.38; 30.84 | 0.525 |
| PRIMARY Caregiver Work Limitations Questionnaire (C-WLQ) - Time |
63.06; 62.41 | 0.723 |
| PRIMARY Caregiver Work Limitations Questionnaire (C-WLQ) - Output |
67.12; 65.34 | 0.569 |
Summary
Unpaid informal caregivers (CGs), such as family and friends, who are also employed may be at significant risk of experiencing burden and stress. This may be especially true for CGs who provide care to care recipients coping with behavioral health issues associated with conditions like depression, anxiety, post-traumatic stress disorder and traumatic brain injury. Stress not only increases the CG's risk of workplace difficulties, illness, and poor quality of life, but also impacts the CG's ability to provide care for the care recipient. The primary aim of this randomized study is to examine the impact of a novel intervention, Caregiver SOS (Self-Management of Stress), on CG distress and work performance and productivity. Caregiver SOS is delivered by phone and offers evidence-based, work and CG role performance-focused self-management counseling to employed CGs. Study findings will ultimately shed light on whether a program that specifically addresses caregiving-work balance is effective in improving CGs' wellbeing and work functioning and the quality of Veterans' care.
Eligibility Criteria
Inclusion Criteria
- Veteran receives care at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), VA Western New York Healthcare System (VAWNYHS), or affiliated community-based outpatient clinics
- Veteran and CG are 18 years of age or older
- Veteran and CG are community dwelling
- Veteran has a confirmed diagnosis of depressive disorder, generalized anxiety disorder, PTSD, and/or TBI (per medical chart/provider report)
- CG is a relative or significant other who endorses that s/he assists the Veteran care recipient (CR) with two or more instrumental activities of daily living (IADLs). IADLS include:
- housework
- managing finances
- arranging/providing transportation (e.g., to medical appointments and community services)
- grocery shopping
- preparing meals
- health management and maintenance (e.g., giving medications, minimizing exposure and response to stress triggers)
- arranging for and/or supervising the delivery of services for assistance with everyday activities
- CG is employed
- CG screens positive for at least mild-moderate distress
- CG screens positive for at least moderate work role difficulty due to caregiving
- CG is willing and able to provide informed consent
Exclusion Criteria
- CG cognitive, hearing, visual, or other physical impairments leading to difficulty with informed consent process, assessment, or participation in intervention visits
- CG unable to speak or read English
Data sourced from ClinicalTrials.gov (NCT04337021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.