Trial Outcomes & Findings for Caregiver Self-Management of Stress (NCT NCT04337021)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

199 participants

Primary outcome timeframe

9 months

Results posted on

2025-11-18

Participant Flow

300 participants were approved; 199 were recruited. The difference between the actual and targeted sample sizes are due to the multiple changes in staffing as well as the COVID pandemic that stalled initial recruitment.

Participant milestones

Participant milestones
Measure	Caregiver SOS 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. CMs will educate CGs about stress. CMs introduce strategies for self-managing stress and design experiments to test these strategies. Progress is monitored to identify strategies that effectively achieve self management goals. CG-SOS care is brief, telephonic care tailored to the CG's needs, preferences, and priorities. SOS care addresses both work and caregiving stress. CG:SOS involves: 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. succeed in implementing them. CMs will educate CGs about stress.	Usual Care 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.
Overall Study STARTED	99	100
Overall Study COMPLETED	45	34
Overall Study NOT COMPLETED	54	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Caregiver SOS 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. CMs will educate CGs about stress. CMs introduce strategies for self-managing stress and design experiments to test these strategies. Progress is monitored to identify strategies that effectively achieve self management goals. CG-SOS care is brief, telephonic care tailored to the CG's needs, preferences, and priorities. SOS care addresses both work and caregiving stress. CG:SOS involves: 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. succeed in implementing them. CMs will educate CGs about stress.	Usual Care 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.
Overall Study Lost to Follow-up	54	66

Baseline Characteristics

Gender item skipped by participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caregiver SOS n=99 Participants Caregiver SOS: 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.	Usual Care n=100 Participants 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.	Total n=199 Participants Total of all reporting groups
Age, Continuous Age	47.89 years STANDARD_DEVIATION 11.76 • n=99 Participants	46.6 years STANDARD_DEVIATION 11.77 • n=100 Participants	47.6 years STANDARD_DEVIATION 11.77 • n=199 Participants
Sex: Female, Male Female	80 Participants n=87 Participants • Gender item skipped by participants.	88 Participants n=94 Participants • Gender item skipped by participants.	168 Participants n=181 Participants • Gender item skipped by participants.
Sex: Female, Male Male	7 Participants n=87 Participants • Gender item skipped by participants.	6 Participants n=94 Participants • Gender item skipped by participants.	13 Participants n=181 Participants • Gender item skipped by participants.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	1 Participants n=100 Participants	2 Participants n=199 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=100 Participants	2 Participants n=199 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=100 Participants	0 Participants n=199 Participants
Race (NIH/OMB) Black or African American	19 Participants n=99 Participants	18 Participants n=100 Participants	37 Participants n=199 Participants
Race (NIH/OMB) White	61 Participants n=99 Participants	80 Participants n=100 Participants	141 Participants n=199 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=100 Participants	0 Participants n=199 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=99 Participants	0 Participants n=100 Participants	17 Participants n=199 Participants

PRIMARY outcome

Timeframe: 9 months

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

Outcome measures

Outcome measures
Measure	Caregiver SOS n=43 Participants 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.	Usual Care n=48 Participants 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.
10-item Kessler Psychological Distress Scale (K10)	23.38 score on a scale Standard Deviation 7.56	23.79 score on a scale Standard Deviation 8.03

PRIMARY outcome

Timeframe: 9 months

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%

Outcome measures

Outcome measures
Measure	Caregiver SOS n=43 Participants 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.	Usual Care n=48 Participants 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.
Caregiver Work Limitations Questionnaire (C-WLQ) - Mental	62.15 units on a scale Standard Deviation 21.18	59.71 units on a scale Standard Deviation 19.79

PRIMARY outcome

Timeframe: 9 months

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%

Outcome measures

Outcome measures
Measure	Caregiver SOS n=43 Participants 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.	Usual Care n=48 Participants 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.
Caregiver Work Limitations Questionnaire (C-WLQ) - Physical	30.38 units on a scale Standard Deviation 31.65	30.84 units on a scale Standard Deviation 29.09

PRIMARY outcome

Timeframe: 9 months

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%

Outcome measures

Outcome measures
Measure	Caregiver SOS n=43 Participants 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.	Usual Care n=48 Participants 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.
Caregiver Work Limitations Questionnaire (C-WLQ) - Time	63.06 units on a scale Standard Deviation 23.9	62.41 units on a scale Standard Deviation 23.79

PRIMARY outcome

Timeframe: 9 months

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%

Outcome measures

Outcome measures
Measure	Caregiver SOS n=43 Participants 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.	Usual Care n=48 Participants 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.
Caregiver Work Limitations Questionnaire (C-WLQ) - Output	67.12 units on a scale Standard Deviation 25.06	65.34 units on a scale Standard Deviation 22.66

Adverse Events

Caregiver SOS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Helstrom

Cprl. Michael J. Crescenz VA Medical Center

Phone: 215-823-4164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place