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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

152 participants

Primary outcome timeframe

24 months

Results posted on

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

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

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

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 months

Population: 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

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 months

The 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 months

The 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 months

The 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 months

The 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: Intake

The 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 months

The 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 months

The 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 months

The 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 months

Frequency, 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)

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

Treatment As Usual (TAU)

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

Serious adverse events

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

Dr. Craig Bryan

University of Utah

Phone: 8015877978

Results disclosure agreements

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