Trial Outcomes & Findings for Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention (NCT NCT04486677)

NCT ID: NCT04486677

Last Updated: 2024-05-02

Results Overview

Feasibility will be measured by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled/completed baseline, and 4) complete follow-up assessments.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Through study completion, approximately 1 year, 8 months
• Results posted on: 2024-05-02

Participant Flow

Participant milestones

Measure	Caring Cards Group Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Overall Study STARTED	30	50
Overall Study COMPLETED	21	34
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention

Baseline characteristics by cohort

Measure	Caring Cards Group n=30 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=50 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	47 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	35 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	50 Participants n=7 Participants	80 Participants n=5 Participants
Era of Military Service Persian Gulf War	26 Participants n=5 Participants	45 Participants n=7 Participants	71 Participants n=5 Participants
Era of Military Service Post-Vietnam	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Era of Military Service Vietnam	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, approximately 1 year, 8 months

Feasibility will be measured by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled/completed baseline, and 4) complete follow-up assessments.

Outcome measures

Measure	Caring Cards Group n=380 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=370 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Feasibility referred for screening	242 Participants	234 Participants
Feasibility determined eligible	212 Participants	233 Participants
Feasibility enrolled/completed baseline	30 Participants	50 Participants
Feasibility complete follow-up assessments	21 Participants	34 Participants

PRIMARY outcome

Timeframe: Through study completion, approximately 1 year, 8 months

Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.

Outcome measures

Measure	Caring Cards Group n=21 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=34 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Intervention Satisfaction Questionnaire (Acceptability) Perception of benefit	13 Participants	21 Participants
Intervention Satisfaction Questionnaire (Acceptability) Recommend to other Veterans	11 Participants	22 Participants

SECONDARY outcome

Timeframe: Change from baseline, an average of 9 months

At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness. Each item on the INQ is rated on a 1-7 Likert scale so the full range of the measure is 12-105, with scores meaning higher thwarted belongingness and perceived burdensomeness (i.e., a worse outcome).

Outcome measures

Measure	Caring Cards Group n=21 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=34 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Interpersonal Needs Questionnaire (INQ-15) Baseline	39.19 score on a scale Standard Deviation 24.07	54.35 score on a scale Standard Deviation 21.15
Interpersonal Needs Questionnaire (INQ-15) 9 month follow up	36.67 score on a scale Standard Deviation 21.16	49.18 score on a scale Standard Deviation 23.13

SECONDARY outcome

Timeframe: Change from baseline, an average of 9 months

At baseline and follow-up, Veterans' suicide risk was assessed using the Beck Scale for Suicide Ideation (BSSI). It is a 19 item measure on a 0-2 point scale for a range of 0-38, with higher scores indicating higher suicidal ideation or worse outcomes. There are two additional questions about suicide attempts that are not included in the total score.

Outcome measures

Measure	Caring Cards Group n=21 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=34 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Suicide Risk Baseline	5.95 score on a scale Standard Deviation 5.83	11.50 score on a scale Standard Deviation 6.33
Suicide Risk 9 month follow up	6.10 score on a scale Standard Deviation 4.55	10.21 score on a scale Standard Deviation 7.31

SECONDARY outcome

Timeframe: Change from baseline, an average of 9 months

At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness. There were three subscales included: Perceived Rejection, Loneliness, and Emotional Support. Each includes items rated on a 1-5 scale. Perceived Rejection is 8 items for a range of 8-40, Loneliness is 5 items for a range of 5-25, and Emotional Support is 8 items for a range of 8-40. Higher scores are associated with worse outcomes for Perceived Rejection and Loneliness, while higher scores are associated with better outcomes for Emotional Support.

Outcome measures

Measure	Caring Cards Group n=21 Participants Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=34 Participants Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
NIH Toolbox Adult Social Relationships Scales Baseline (Perceived Rejection)	17.52 score on a scale Standard Deviation 9.10	21.79 score on a scale Standard Deviation 8.29
NIH Toolbox Adult Social Relationships Scales Follow up (Perceived Rejection)	18.91 score on a scale Standard Deviation 8.58	18.41 score on a scale Standard Deviation 8.37
NIH Toolbox Adult Social Relationships Scales Baseline (Loneliness)	14.19 score on a scale Standard Deviation 6.42	18.59 score on a scale Standard Deviation 4.83
NIH Toolbox Adult Social Relationships Scales Follow up (Loneliness)	13.38 score on a scale Standard Deviation 5.81	17.29 score on a scale Standard Deviation 6.59
NIH Toolbox Adult Social Relationships Scales Baseline (Emotional support)	31.19 score on a scale Standard Deviation 8.69	26.18 score on a scale Standard Deviation 8.69
NIH Toolbox Adult Social Relationships Scales Follow up (Emotional support)	31.52 score on a scale Standard Deviation 9.67	29.47 score on a scale Standard Deviation 10.50

Adverse Events

Caring Cards Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caring Cards Recipients

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Caring Cards Group n=30 participants at risk Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=50 participants at risk Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Psychiatric disorders Suicide attempt	0.00% 0/30 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months. Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.	4.0% 2/50 • Number of events 2 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months. Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.

Other adverse events

Measure	Caring Cards Group n=30 participants at risk Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers.	Caring Cards Recipients n=50 participants at risk Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients.
Psychiatric disorders Suicide attempt	0.00% 0/30 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months. Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.	12.0% 6/50 • Number of events 6 • Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months. Systematic method: Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.

Additional Information

Dr. Emily Treichler

VA San Diego

Phone: 6192288075

Email: emily.treichler@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place