Trial Outcomes & Findings for A Pilot of the Brief Relationship Checkup (NCT NCT06011161)

NCT ID: NCT06011161

Last Updated: 2024-10-01

Results Overview

Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Pre-treatment

Results posted on

2024-10-01

Participant Flow

N/A. All participants are considered assigned to the treatment condition from the moment of couple enrollment.

Participant milestones

Participant milestones
Measure
Brief Relationship Checkup
Couples in the experimental condition will participate in three joint sessions of the Brief Relationship Checkup (BRC; Cordova 2014; Cigrang et al., 2016). This program has been tested in Air Force Primary Care but we do not know if veterans with mental health concerns will be able to attend it (feasibility), complete it safely (tolerability), and enjoy it (acceptability). Brief Relationship Checkup (BRC): The investigators are using the three 30-minute session protocol developed for Air Force Primary Care (Cigrang et al., 2016). Although it is simply referred to as the "Marriage Checkup" in that manuscript, the investigators use the name BRC to distinguish it from many other versions of Dr. James Cordova's Marriage Checkup (Cordova, 2014) adapted for different settings. Sessions in this version are briefer than other versions (30 mins vs. 60-90 mins) and this trial does not have any eligibility restrictions based on marital status.
Overall Study
STARTED
40
Overall Study
COMPLETED
33
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Brief Relationship Checkup
Couples in the experimental condition will participate in three joint sessions of the Brief Relationship Checkup (BRC; Cordova 2014; Cigrang et al., 2016). This program has been tested in Air Force Primary Care but we do not know if veterans with mental health concerns will be able to attend it (feasibility), complete it safely (tolerability), and enjoy it (acceptability). Brief Relationship Checkup (BRC): The investigators are using the three 30-minute session protocol developed for Air Force Primary Care (Cigrang et al., 2016). Although it is simply referred to as the "Marriage Checkup" in that manuscript, the investigators use the name BRC to distinguish it from many other versions of Dr. James Cordova's Marriage Checkup (Cordova, 2014) adapted for different settings. Sessions in this version are briefer than other versions (30 mins vs. 60-90 mins) and this trial does not have any eligibility restrictions based on marital status.
Overall Study
Withdrawal by Subject
2
Overall Study
Lost to Follow-up
5

Baseline Characteristics

A Pilot of the Brief Relationship Checkup

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Screened Veteran
n=20 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Supporting Partner
n=20 Participants
This is the second partner that is referred to the study. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we refer to those participants as "Second Partners" or simply "Partners" for short.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
42.60 years
STANDARD_DEVIATION 13.68 • n=99 Participants
41.45 years
STANDARD_DEVIATION 13.95 • n=107 Participants
42.03 years
STANDARD_DEVIATION 13.65 • n=206 Participants
Sex: Female, Male
Female
3 Participants
n=99 Participants
17 Participants
n=107 Participants
20 Participants
n=206 Participants
Sex: Female, Male
Male
17 Participants
n=99 Participants
3 Participants
n=107 Participants
20 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=99 Participants
0 Participants
n=107 Participants
4 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=99 Participants
20 Participants
n=107 Participants
36 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=99 Participants
5 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
White
14 Participants
n=99 Participants
14 Participants
n=107 Participants
28 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
Region of Enrollment
United States
20 participants
n=99 Participants
20 participants
n=107 Participants
40 participants
n=206 Participants
Veteran Status
Veteran
20 Participants
n=99 Participants
2 Participants
n=107 Participants
22 Participants
n=206 Participants
Veteran Status
Non-Veteran
0 Participants
n=99 Participants
18 Participants
n=107 Participants
18 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Pre-treatment

Population: Full sample

Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=20 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=20 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Relationship Functioning
84.99 score on a scale
Standard Error 6.60
90.90 score on a scale
Standard Error 6.60

PRIMARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: Participants completing the measure at follow-up.

Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=15 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Relationship Functioning
117.66 score on a scale
Standard Error 6.97
106.81 score on a scale
Standard Error 6.88

SECONDARY outcome

Timeframe: Pre-treatment

Population: Whole sample

Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding from one's partner.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=20 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=20 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Emotional Intimacy/Mutual Responsiveness
41.64 score on a scale
Standard Error 4.49
44.80 score on a scale
Standard Error 4.49

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: Participants completing the measure at follow-up.

Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding (i.e., greater emotional intimacy).

Outcome measures

Outcome measures
Measure
Screened Veteran
n=15 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Emotional Intimacy/Mutual Responsiveness
58.87 score on a scale
Standard Error 4.65
50.67 score on a scale
Standard Error 4.61

SECONDARY outcome

Timeframe: Pre-treatment

Population: Full sample

Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=20 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=20 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Depressive Symptoms
11.00 score on a scale
Standard Error 0.98
7.50 score on a scale
Standard Error 0.98

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: Participants completing the measure at follow-up.

Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=15 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Depressive Symptoms
8.17 score on a scale
Standard Error 1.08
4.24 score on a scale
Standard Error 1.06

SECONDARY outcome

Timeframe: Pre-treatment

Population: All participants completing measure at baseline. Two participants missing data as measure is on last page.

Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=19 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=19 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Perceived Burdensomeness
11.14 score on a scale
Standard Error 1.05
7.84 score on a scale
Standard Error 1.07

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: All participants completing the measure at follow-up, with the exception of two screened Veterans who reported a 10-point reduction in burdensomeness who were removed from analysis in order to create a conservative estimate of reduction.

Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=13 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Perceived Burdensomeness
9.76 score on a scale
Standard Error 1.09
7.06 score on a scale
Standard Error 1.09

SECONDARY outcome

Timeframe: Pre-treatment

Population: All participants completing measure at baseline. Two participants missing data as measure is on last page.

Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=19 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=19 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Thwarted Belongingness
31.26 score on a scale
Standard Error 2.43
28.32 score on a scale
Standard Error 2.47

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: Participants completing the measure at follow-up.

Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=15 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Thwarted Belongingness
23.75 score on a scale
Standard Error 2.55
23.50 score on a scale
Standard Error 2.55

SECONDARY outcome

Timeframe: Pre-treatment

Population: All participants

Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=20 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=20 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Suicide Ideation Severity
No ideation (Score=0)
18 Participants
20 Participants
Suicide Ideation Severity
Passive Death Ideation (Score=1)
1 Participants
0 Participants
Suicide Ideation Severity
Ideation with Plan (Score=3)
1 Participants
0 Participants

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: Participants who completed as C-SSRS interview.

Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=16 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=17 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Suicide Ideation Severity
No Ideation (Score=0)
14 Participants
17 Participants
Suicide Ideation Severity
Passive Death Ideation (Score=1)
2 Participants
0 Participants
Suicide Ideation Severity
Suicidal Ideation with Plan (Score=3)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: After Completing the BRC Program (1-3months after pre-treatment)

Population: All participants completing the follow-up survey.

Treatment acceptability was assessed using the Client Satisfaction Questionnaire (CSQ, Larsen et al., 1979). Scores range from 1-4 with scores greater than 3 representing satisfaction with the treatment.

Outcome measures

Outcome measures
Measure
Screened Veteran
n=15 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=16 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Treatment Acceptability
3.49 score on a scale
Standard Deviation 0.50
3.43 score on a scale
Standard Deviation 0.52

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 day period before pre-treatment session

Population: Participants who completed treatment and had accessible charts in the VA medical record

Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).

Outcome measures

Outcome measures
Measure
Screened Veteran
n=18 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=3 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Number of Mental Health and Family Contacts
3.39 days of care
Standard Deviation 3.11
0.33 days of care
Standard Deviation 0.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)

Population: Participants who completed treatment and had accessible charts in the VA medical record

Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).

Outcome measures

Outcome measures
Measure
Screened Veteran
n=18 Participants
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=3 Participants
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Number of Mental Health and Family Contacts
4.78 days of care
Standard Deviation 4.33
2.67 days of care
Standard Deviation 3.79

Adverse Events

Screened Veteran

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Second Partner

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Screened Veteran
n=20 participants at risk
This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short.
Second Partner
n=20 participants at risk
This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short.
Social circumstances
Intimate Partner Violence Event
5.0%
1/20 • Number of events 1 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
5.0%
1/20 • Number of events 1 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
Psychiatric disorders
Non-Suicidal Self-Injury
0.00%
0/20 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
0.00%
0/20 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
Psychiatric disorders
Suicidal Behavior
0.00%
0/20 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
0.00%
0/20 • Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.

Additional Information

Dev Crasta

VISN 2 Center of Excellence for Suicide Prevention

Phone: 585-364-8119

Results disclosure agreements

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