Trial Outcomes & Findings for Brief Cognitive Behavioral Therapy for Military Populations (NCT NCT02038075)
NCT ID: NCT02038075
Last Updated: 2023-12-12
Results Overview
The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).
COMPLETED
NA
152 participants
24 months
2023-12-12
Participant Flow
Participants were identified during weekly behavioral health treatment team meetings and daily emergency department reports. All soldiers admitted to inpatient psychiatric hospitalization for suicidal ideation or for a suicide attempt from January 2011 to September 2012 were referred upon discharge for determination of eligibility.
30 of 206 referred Soldiers were excluded (15 due to planned move in next 6 months, 15 refused). 24 of 176 consenting to participate were excluded (22 ineligible, 2 dropped before randomization).
Participant milestones
| Measure |
Brief Cognitive Behavioral Therapy (BCBT)
In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)
|
Treatment As Usual (TAU)
Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
73
|
76
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Brief Cognitive Behavioral Therapy (BCBT)
In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)
|
Treatment As Usual (TAU)
Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Brief Cognitive Behavioral Therapy for Military Populations
Baseline characteristics by cohort
| Measure |
Brief Cognitive Behavioral Therapy (BCBT)
n=76 Participants
In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)
|
Treatment As Usual (TAU)
n=76 Participants
Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.18 years
STANDARD_DEVIATION 6.25 • n=99 Participants
|
27.62 years
STANDARD_DEVIATION 621 • n=107 Participants
|
27.40 years
STANDARD_DEVIATION 6.20 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
118 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/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
58 participants
n=99 Participants
|
52 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Military rank
E1-E4
|
60 participants
n=99 Participants
|
51 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Military rank
E5-E6
|
15 participants
n=99 Participants
|
20 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Military rank
E7-E9
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Military rank
Warrant Officer
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Deployment history
None
|
18 participants
n=99 Participants
|
10 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Deployment history
One
|
28 participants
n=99 Participants
|
31 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Deployment history
Multiple (2+)
|
30 participants
n=99 Participants
|
35 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Prior suicide attempts
None
|
17 participants
n=99 Participants
|
19 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Prior suicide attempts
One
|
24 participants
n=99 Participants
|
34 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Prior suicide attempts
Multiple (2+)
|
35 participants
n=99 Participants
|
23 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Major depressive
|
55 participants
n=99 Participants
|
63 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Posttraumatic stress
|
26 participants
n=99 Participants
|
34 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Substance dependence
|
13 participants
n=99 Participants
|
7 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Alcohol dependence
|
11 participants
n=99 Participants
|
7 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Social phobia
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Panic
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Anxiety
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Depressive personality
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Borderline personality
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Psychiatric diagnosis (SCID)
Antisocial personality
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Medications
Antidepressant
|
47 participants
n=99 Participants
|
47 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Medications
Anticonvulsant
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Medications
Antihypertensive
|
11 participants
n=99 Participants
|
16 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Medications
Antipsychotic
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Medications
Anxiolytic
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Medications
Benzodiazepine
|
6 participants
n=99 Participants
|
12 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Medications
Muscle relaxer
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Medications
Opioid
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Medications
Opioid antagonis
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Medications
Sleep/hypnotic
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Medications
Stimulant
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Medications
Other
|
16 participants
n=99 Participants
|
18 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Beck Scale for Suicide Ideation, Current
|
10.83 units on a scale
STANDARD_DEVIATION 8.67 • n=99 Participants
|
11.07 units on a scale
STANDARD_DEVIATION 8.43 • n=107 Participants
|
10.95 units on a scale
STANDARD_DEVIATION 8.53 • n=206 Participants
|
|
Beck Scale for Suicide Ideation, Worst
|
19.16 units on a scale
STANDARD_DEVIATION 9.30 • n=99 Participants
|
19.07 units on a scale
STANDARD_DEVIATION 8.69 • n=107 Participants
|
19.11 units on a scale
STANDARD_DEVIATION 8.97 • n=206 Participants
|
|
Beck Hopelessness Scale
|
12.87 units on a scale
STANDARD_DEVIATION 6.12 • n=99 Participants
|
12.72 units on a scale
STANDARD_DEVIATION 6.02 • n=107 Participants
|
12.80 units on a scale
STANDARD_DEVIATION 6.05 • n=206 Participants
|
|
Beck Depression Inventory, 2nd Edition
|
31.95 units on a scale
STANDARD_DEVIATION 14.26 • n=99 Participants
|
33.51 units on a scale
STANDARD_DEVIATION 13.39 • n=107 Participants
|
32.73 units on a scale
STANDARD_DEVIATION 13.81 • n=206 Participants
|
|
Beck Anxiety Inventory
|
28.87 units on a scale
STANDARD_DEVIATION 14.78 • n=99 Participants
|
29.74 units on a scale
STANDARD_DEVIATION 13.96 • n=107 Participants
|
29.30 units on a scale
STANDARD_DEVIATION 14.33 • n=206 Participants
|
|
PTSD Checklist, Military Version
|
55.15 units on a scale
STANDARD_DEVIATION 18.10 • n=99 Participants
|
57.39 units on a scale
STANDARD_DEVIATION 15.63 • n=107 Participants
|
56.27 units on a scale
STANDARD_DEVIATION 16.89 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: intent to treat
The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).
Outcome measures
| Measure |
Brief Cognitive Behavioral Therapy (BCBT)
n=76 Participants
In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)
|
Treatment As Usual (TAU)
n=76 Participants
Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)
|
|---|---|---|
|
Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up
|
13.8 estimated percentage w/ suicide attempt
|
40.2 estimated percentage w/ suicide attempt
|
SECONDARY outcome
Timeframe: 24 monthsThe SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsThe BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsThe BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsThe BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: IntakeThe SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsThe SIS is a 15-item, interviewer-administered assessment of the intensity of an individual's intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters' perceptions of the attempt.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsThe INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsThe SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsFrequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review.
Outcome measures
Outcome data not reported
Adverse Events
Brief Cognitive Behavioral Therapy (BCBT)
Treatment As Usual (TAU)
Serious adverse events
| Measure |
Brief Cognitive Behavioral Therapy (BCBT)
n=76 participants at risk
In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
Brief Cognitive Behavioral Therapy (BCBT)
|
Treatment As Usual (TAU)
n=76 participants at risk
Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.
Treatment As Usual (TAU)
|
|---|---|---|
|
Psychiatric disorders
Suicide death
|
1.3%
1/76 • Number of events 1
|
1.3%
1/76 • 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