Caregiver Self-Management of Stress

NCT04337021 | Completed Results DMC

• 3 other identifiers: IIR 18-290018452020-009
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Caregiver Distress; Job Stress

Keywords

psychological stress; family caregivers; work stress; spouse caregivers; life stress

Outcome Measures

Primary Outcomes (5)

• 10-item Kessler Psychological Distress Scale (K10)

  Global measure of psychological distress; scores range from 10-50, with higher scores indicating worse outcomes (higher levels of distress)

  9 months

• Caregiver Work Limitations Questionnaire (C-WLQ) - Mental

  25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%

  9 months

• Caregiver Work Limitations Questionnaire (C-WLQ) - Physical

  25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%

  9 months

• Caregiver Work Limitations Questionnaire (C-WLQ) - Time

  25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%

  9 months

• Caregiver Work Limitations Questionnaire (C-WLQ) - Output

  25-item measure capturing the extent to which caregiving has impacted work performance and productivity; scores range from 0-100%, with higher scores indicating worse outcomes (greater work difficulty) The C-WLQ Mental Subscale has scores ranging from 0-100%

  9 months

Study Arms (2)

Caregiver SOS

ACTIVE COMPARATOR

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.

Behavioral: Caregiver SOS

Usual Care

NO 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.

Interventions

Caregiver SOS BEHAVIORAL

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 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.

Caregiver SOS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• The VA Western New York Healthcare System: collaborator

Study Sites (2)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

MeSH Terms

Conditions

Occupational Stress; Stress, Psychological

Condition Hierarchy (Ancestors)

Occupational Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Amy Helstrom
• Organization: Cprl. Michael J. Crescenz VA Medical Center

amy.helstrom@va.gov

215-823-4164

Study Officials

• Amy W Helstrom, PhD

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

• Laura O Wray, PhD

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Caregiver SOS is delivered by phone and offers evidence-based, work and CG role performance-focused self-management counseling to employed CGs. The program includes 6, 1-hour telephonic sessions with a care manager.

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: December 28, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)