Trial Outcomes & Findings for Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations (NCT NCT02042131)
NCT ID: NCT02042131
Last Updated: 2017-08-11
Results Overview
Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-11
Participant Flow
Participant milestones
| Measure |
Treatment As Usual (TAU)
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
|
Enhanced Crisis Response Plan (E-CRP)
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
33
|
|
Overall Study
COMPLETED
|
32
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations
Baseline characteristics by cohort
| Measure |
Treatment As Usual (TAU)
n=32 Participants
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 Participants
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 Participants
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
27.0 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
26.0 years
STANDARD_DEVIATION 6.8 • n=27 Participants
|
26.1 years
STANDARD_DEVIATION 6.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: all participants enrolled, regardless of dropout or withdrawal
Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent
Outcome measures
| Measure |
Treatment As Usual (TAU)
n=32 Participants
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 Participants
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 Participants
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Estimated Proportion of Participants With Suicide Attempt
|
0.19 estimated proportion of participants
|
0.03 estimated proportion of participants
|
0.06 estimated proportion of participants
|
SECONDARY outcome
Timeframe: 1 month, 3 months, and 6 monthsThe BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.
Outcome measures
| Measure |
Treatment As Usual (TAU)
n=32 Participants
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 Participants
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 Participants
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Beck Scale for Suicide Ideation (BSSI)
1 month
|
8.4 units on a scale
Standard Error 1.4
|
5.3 units on a scale
Standard Error 1.4
|
3.5 units on a scale
Standard Error 1.5
|
|
Beck Scale for Suicide Ideation (BSSI)
3 months
|
5.8 units on a scale
Standard Error 1.5
|
6.0 units on a scale
Standard Error 1.5
|
3.3 units on a scale
Standard Error 1.6
|
|
Beck Scale for Suicide Ideation (BSSI)
6 months
|
7.3 units on a scale
Standard Error 1.5
|
2.5 units on a scale
Standard Error 1.6
|
1.9 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 6 monthsMean number of days of inpatient psychiatric hospitalization
Outcome measures
| Measure |
Treatment As Usual (TAU)
n=32 Participants
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 Participants
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 Participants
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Inpatient Psychiatric Hospitalization Days
|
2.5 days
Standard Error 0.6
|
0.9 days
Standard Error 0.2
|
1.2 days
Standard Error 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post-interventionDoctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention.
Outcome measures
| Measure |
Treatment As Usual (TAU)
n=32 Participants
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 Participants
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Standard Crisis Response Plan (S-CRP)
Enhanced Crisis Response Plan (E-CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 Participants
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician
|
6 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
Treatment As Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Crisis Response Plan (S-CRP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Crisis Response Plan (E-CRP)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment As Usual (TAU)
n=32 participants at risk
TAU includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. provision of professional and crisis contact information
4. referral to mental health treatment and community resources
5. verbal contract for safety
Treatment As Usual (TAU)
|
Standard Crisis Response Plan (S-CRP)
n=32 participants at risk
CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify social support contacts
6. provision of professional and crisis contact information
7. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
|
Enhanced Crisis Response Plan (E-CRP)
n=33 participants at risk
The E-CRP includes the following intervention components:
1. suicide risk assessment
2. supportive listening
3. identify personal warning signs
4. identify self-management skills
5. identify reasons for living
6. identify social support contacts
7. provision of professional and crisis contact information
8. referral to mental health treatment and community resources
Treatment As Usual (TAU)
Crisis Response Plan (CRP)
Enhanced Crisis Response Plan (E-CRP)
|
|---|---|---|---|
|
Nervous system disorders
Death by suicide
|
0.00%
0/32
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place