Trial Outcomes & Findings for Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life (NCT NCT03615222)
NCT ID: NCT03615222
Last Updated: 2024-10-24
Results Overview
The Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008) is a state-of-the-art suicide assessment for individuals perceived to be at high risk for suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 2011). Values on the intensity of suicidal ideation (e.g., frequency, duration, controllability, deterrents, reasons for ideation) are summed to create a total score; range from 0 to 25, where higher scores indicate higher SI severity.
COMPLETED
377 participants
Baseline and 24-month
2024-10-24
Participant Flow
Participant milestones
| Measure |
SERVE Assessment Only
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Overall Study
STARTED
|
377
|
|
Overall Study
COMPLETED
|
343
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
SERVE Assessment Only
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Overall Study
Ineligible
|
26
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
Baseline characteristics by cohort
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
340 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Age, Continuous
|
46.20 years
STANDARD_DEVIATION 9.08 • n=93 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
246 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
291 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
103 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
351 Participants
n=93 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
27.47 units on a scale
STANDARD_DEVIATION 20.77 • n=93 Participants
|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
3.54 units on a scale
STANDARD_DEVIATION 5.12 • n=93 Participants
|
|
Drug Abuse Screening Test (DAST-10)
|
1.13 units on a scale
STANDARD_DEVIATION .97 • n=93 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
10.09 units on a scale
STANDARD_DEVIATION 6.56 • n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24-monthPopulation: Analysis at 24-month includes the 216 participants who completed the clinical assessment at follow-up.
The Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008) is a state-of-the-art suicide assessment for individuals perceived to be at high risk for suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 2011). Values on the intensity of suicidal ideation (e.g., frequency, duration, controllability, deterrents, reasons for ideation) are summed to create a total score; range from 0 to 25, where higher scores indicate higher SI severity.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Columbia Suicide Scale
Baseline
|
1.19 score on a scale
Standard Deviation 3.76
|
|
Columbia Suicide Scale
24-month
|
1.09 score on a scale
Standard Deviation 3.67
|
PRIMARY outcome
Timeframe: Baseline, 8-month, 16-month, and 24-monthPopulation: Differences in participants reflect number completed at each timepoint.
Self-report assessment of functional disability with total score and 6 domains of functioning: understanding and communicating, mobility, getting along with others, life activities (i.e., work, education, household responsibilities), participation in society, and self-care (Ustun et al., 2010). Both global and specific areas of functioning are crucial in thoroughly understanding functional recovery, as Veterans may function well in one area and have difficulty in another. Moreover, some domains may be affected by contextual factors instead of representing functional capacity (e.g., work functioning in a struggling economy independent of impairment). Means on this measure capture items from all domain subscales and can range from 0 to 3 where higher scores indicate higher levels of disability.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Baseline
|
1.20 score on a scale
Standard Deviation .80
|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
8-month
|
1.28 score on a scale
Standard Deviation .77
|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
16-month
|
1.21 score on a scale
Standard Deviation .80
|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
24-month
|
1.03 score on a scale
Standard Deviation .79
|
PRIMARY outcome
Timeframe: Baseline and 24-monthThe Clinician Administered NSSI Disorder Index (CANDI) is a clinical interview that diagnoses Nonsuicidal Self Injury (NSSI) disorder and type and frequency of NSSI. Demonstrated good reliability and validity in prior research. Results report the number of participants that meet for a diagnosis of NSSID.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Clinician Administered NSSI Disorder Index (CANDI)
24-month - Current NSSID
|
5 Participants
|
|
Clinician Administered NSSI Disorder Index (CANDI)
Baseline - Lifetime NSSID
|
31 Participants
|
|
Clinician Administered NSSI Disorder Index (CANDI)
Baseline - Current NSSID
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8-month, 16-month, and 24-monthPopulation: Differences in participants reflect number completed at each timepoint.
Self-report measure (Marx et al., 2009; Bovin et al., 2018) of problems in different domains of life (e.g., Romantic Relationships with a Spouse/Partner, Family, Work, Friendships and Socializing, Parenting, Education, and Self-Care). The short version has a .90 correlation with the full 80-item instrument (Co-I Marx, personal communication). Adjusted totals range from 0 to 100 with higher scores indicate greater functional impairment.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Inventory of Psychosocial Functioning (IPF) - Brief
Baseline
|
44.96 score on a scale
Standard Deviation 23.06
|
|
Inventory of Psychosocial Functioning (IPF) - Brief
8-month
|
48.02 score on a scale
Standard Deviation 22.64
|
|
Inventory of Psychosocial Functioning (IPF) - Brief
16-month
|
46.04 score on a scale
Standard Deviation 22.85
|
|
Inventory of Psychosocial Functioning (IPF) - Brief
24-month
|
39.89 score on a scale
Standard Deviation 23.46
|
PRIMARY outcome
Timeframe: Baseline and 24-monthPopulation: Differences in participants reflect number completed at each timepoint.
Widely-used self-report measure of intensity of thoughts and behaviors associated with suicide. Includes 2 additional items that ask about past suicide attempts as well as the level of suicidal intent during the most recent attempt. Prior research shows that endorsement of suicidal thoughts and behaviors can be greater on self-report questionnaires compared to interviews. Total scores range from 0 to 42 where higher scores indicate higher suicidal ideation.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Beck Scale for Suicide Ideation (BSSI)
Baseline
|
1.99 score on a scale
Standard Deviation 4.66
|
|
Beck Scale for Suicide Ideation (BSSI)
24-month
|
1.61 score on a scale
Standard Deviation 4.16
|
PRIMARY outcome
Timeframe: Baseline, 8-month, 16-month, and 24-monthPopulation: Differences in participants reflect number completed at each timepoint.
Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in different areas of their life, distinct from health status, (e.g., mate, physical well-being, relationships with others, social, community, and civic activities, personal development and fulfillment, recreation, and independence). Good internal consistency and high test-retest reliability (Burckhardt et al. 2003). Total scores range from 16 to 112 with higher scores indicating greater life satisfaction.
Outcome measures
| Measure |
SERVE Assessment Only
n=351 Participants
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Quality of Life Scale
Baseline
|
75.03 score on a scale
Standard Deviation 18.39
|
|
Quality of Life Scale
8-month
|
72.09 score on a scale
Standard Deviation 18.35
|
|
Quality of Life Scale
16-month
|
73.38 score on a scale
Standard Deviation 18.90
|
|
Quality of Life Scale
24-month
|
76.56 score on a scale
Standard Deviation 19.18
|
Adverse Events
SERVE Assessment Only
Serious adverse events
| Measure |
SERVE Assessment Only
n=351 participants at risk
Eligible veterans will complete 4 assessments over a two year period of time.
|
|---|---|
|
Psychiatric disorders
Mental Health Hospitalization
|
1.4%
5/351 • Number of events 5 • 2 years
|
|
General disorders
Jailed
|
1.1%
4/351 • Number of events 4 • 2 years
|
|
General disorders
Minor Surgery
|
4.6%
16/351 • Number of events 16 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place