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Narrative Exposure Therapy (NET)

Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03777553
Acronym
NET
Enrollment
9
Registered
2018-12-17
Start date
2019-06-13
Completion date
2021-02-24
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder, criminal justice, Veterans

Brief summary

The purpose of this study is to learn more about Narrative Exposure Therapy for Justice Involved Veterans. This pilot study will examine the feasibility of this intervention in a justice-involved veteran population, and will see whether the intervention needs to be tailored to best meet their needs. The investigators will examine whether the intervention impacts key clinical outcomes, including posttraumatic stress disorder symptoms, as well as on measures of moral injury, anger, depression, suicidality, and aggression.

Detailed description

The overall objective of this application is to gather data on the use of Narrative Exposure Therapy for Justice Involved Veterans (VETNET) in a pilot sample of justice-involved Veterans with PTSD, with a particular focus on obtaining data on feasibility and acceptability of the intervention in a justice-involved veteran population, and determining what further adaptations are needed to tailor this intervention to justice-involved Veterans (JIV). The investigators are also interested in evaluating whether the intervention has the potential to have an effect on key clinical outcomes, including posttraumatic stress disorder (PTSD) symptoms, as well as on measures of moral injury, anger, depression, suicidality, and aggression. The following Specific Aims have been developed for this project: Aim 1: Evaluate study feasibility and treatment delivery procedures of Narrative Exposure Therapy for Justice Involved Veterans (VETNET) in justice-involved Veterans (JIV) with PTSD. Data gathered will include recruitment rates, drop-out rates, adverse event frequency and severity, and participant engagement in treatment. As necessary, identify further adaptations that are needed to tailor this intervention specifically to JIV. Aim 2: Evaluate the impact of VETNET on PTSD symptoms, as well as on related outcomes including moral injury, anger, depression, suicidality, and aggression.

Interventions

BEHAVIORALNarrative Exposure Therapy for Justice-Involved Veterans

Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a single group pre/post trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Is a veteran; * Recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year; * Meets current criteria for PTSD.

Exclusion criteria

* Currently incarcerated; * Current, active psychosis; * Is at imminent risk for suicide or homicide warranting immediate intervention; * Substance abuse that is severe enough to prevent full engagement in the study protocol; * Concurrent trauma-focused psychotherapy including Prolonged Exposure Therapy, Cognitive Processing Therapy, or EMDR; * Is unable to unwilling to complete study procedures.

Design outcomes

Primary

MeasureTime frameDescription
Beck Depression Inventory (BDI-2)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.The BDI-2 is a 21-item scale that evaluates symptoms of depression. Total score range is from 0 to 63, with higher scores indicating greater depression. Negative change scores reflect decrease in depression from pre to post treatment; positive change scores reflect increase in depression from pre to post treatment.
PTSD Checklist for the DSM-5 (PCL-5)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.On the PCL-5 participants first report an autobiographical narrative of a trauma, and subsequently rate how bothered they were by each symptom (0 \[not at all\] - 4 \[extremely\]) for all DSM-V PTSD symptoms within the past week. Total score range is 0 to 80, with higher scores reflecting greater symptomatology. Positive change score reflects increase in PTSD symptoms from baseline to post-treatment; negative change score reflects decrease in PTSD symptoms from baseline to post-treatment.
Dimensions of Anger Reactions (DAR)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. It was found to have concurrent and discriminant validity, and to correlate highly with measures of functional impairment, in a large sample of treatment-seeking soldiers who had served in Iraq or Afghanistan. Score range is from 0-56, with higher score reflecting greater problems with anger. Positive change score reflects increase in anger interference from baseline to post-treatment; negative change score reflects decrease in anger interference from baseline to post-treatment.
The Appetitive Aggression Scale (AAS)Change in total score from baseline to end of treatment (approximately 10-12 weeks)This scale has two parts. Part 1 is a 17-item scale that asked participants to mark whether they have engaged in or witness specific violent acts. 15 of these items measure acts that could reflect appetitive aggression (.made another person scream in pain), and two are more clearly reactive (...defended yourself in a fight). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 is administered. Data from Part 2 is what is presented here. Part 2 is a 19-item scale that evaluates (yes or no) whether the participant enjoys engaging in violence. Only the first 15 items are scored because these reflect appetitive aggression (the last 4 items evaluate reactive aggression). Total score on Part 2 ranges from 0 to 15, with higher score reflecting greater appetitive aggression. Negative change score reflects decreases in appetitive aggression from baseline to post-treatment; positive change scores reflect increases.

Secondary

MeasureTime frameDescription
The Moral Injury Events Scale (MIES)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.The MIES is an 11-item scale that measures moral injury associated with experiences during military service. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11 to 66, with higher scores reflecting greater moral injury. Positive change scores reflect increase in moral injury from pre to post treatment; negative change scores reflect decrease in moral injury from pre to post treatment.
Revised Conflict Tactics Scales (CTS2)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant. Participants answer how often these behaviors were perpetrated by them within a specified time period: 0 (never); 1 (once); 2 (twice); 3 (3-5 times); 4 (6-10 times); 5 (11-20 times); 6 (more than 20 times). The original CTS2 instructions will be modified to more appropriately reflect the goals of this study: 1) the target of the behavior will be expanded from partner to anyone; and 2) the time frame of the response will be reduced from one year to three months to detect potential changes associated with treatment. Two subscale scores were used for these analyses: Psychological Aggression (range = 0 to 48) and Physical Assault (range = 0 to 72), with higher scores reflecting greater use of aggression.
Trauma-Related Guilt Index (TRGI)Change in total score from baseline to end of treatment (approximately 10-12 weeks)Guided by appraisal theories of emotion, the 32-item TRGI is an index of guilt associated with the experience of trauma. Participants rate statements on a 5-point scale ranging from extremely true/extremely guilty (4) to not at all true/not guilty at all (0). Total scores range from 0 to 128, with higher scores reflecting greater trauma-related guilt.
Interpersonal Needs Questionnaire (INQ)Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Based upon the Interpersonal Theory of Suicide (Joiner Jr et al., 2009), the INQ measures two proximal causes of the desire for suicide: Thwarted belongingness and Perceived burdensomeness. Participants rate each of the 15 items on a scale of 1 (not at all true for me) to 7 (very true for me). Total scores range from 15 to 105, with greater scores reflecting higher levels of suicide-related cognitions.

Countries

United States

Participant flow

Participants by arm

ArmCount
VETNET
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
5
Total5

Baseline characteristics

CharacteristicVETNET
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
Age, Continuous44.2 years
STANDARD_DEVIATION 9.18
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
2 Participants
Region of Enrollment
United States
5 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 9
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

Beck Depression Inventory (BDI-2)

The BDI-2 is a 21-item scale that evaluates symptoms of depression. Total score range is from 0 to 63, with higher scores indicating greater depression. Negative change scores reflect decrease in depression from pre to post treatment; positive change scores reflect increase in depression from pre to post treatment.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETBeck Depression Inventory (BDI-2)Baseline19.2 units on a scaleStandard Deviation 5.5
VETNETBeck Depression Inventory (BDI-2)post-treatment13.2 units on a scaleStandard Deviation 7.9
VETNETBeck Depression Inventory (BDI-2)3 months post-treatment11.3 units on a scaleStandard Deviation 8.8
VETNETBeck Depression Inventory (BDI-2)mean of change score from baseline to post-treatment-6 units on a scaleStandard Deviation 6.6
VETNETBeck Depression Inventory (BDI-2)mean of change score from baseline to 3-months post-treatment-5.8 units on a scaleStandard Deviation 9.3
Primary

Dimensions of Anger Reactions (DAR)

The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. It was found to have concurrent and discriminant validity, and to correlate highly with measures of functional impairment, in a large sample of treatment-seeking soldiers who had served in Iraq or Afghanistan. Score range is from 0-56, with higher score reflecting greater problems with anger. Positive change score reflects increase in anger interference from baseline to post-treatment; negative change score reflects decrease in anger interference from baseline to post-treatment.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETDimensions of Anger Reactions (DAR)Baseline32 units on a scaleStandard Deviation 13.5
VETNETDimensions of Anger Reactions (DAR)Post-treatment37.8 units on a scaleStandard Deviation 12.8
VETNETDimensions of Anger Reactions (DAR)3 months post-treatment18.3 units on a scaleStandard Deviation 10.3
VETNETDimensions of Anger Reactions (DAR)mean change score from baseline to post-treatment5.8 units on a scaleStandard Deviation 5.8
VETNETDimensions of Anger Reactions (DAR)mean change score from baseline to 3 months post-treatment-9.5 units on a scaleStandard Deviation 5.8
Primary

PTSD Checklist for the DSM-5 (PCL-5)

On the PCL-5 participants first report an autobiographical narrative of a trauma, and subsequently rate how bothered they were by each symptom (0 \[not at all\] - 4 \[extremely\]) for all DSM-V PTSD symptoms within the past week. Total score range is 0 to 80, with higher scores reflecting greater symptomatology. Positive change score reflects increase in PTSD symptoms from baseline to post-treatment; negative change score reflects decrease in PTSD symptoms from baseline to post-treatment.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETPTSD Checklist for the DSM-5 (PCL-5)baseline47.8 units on a scaleStandard Deviation 15
VETNETPTSD Checklist for the DSM-5 (PCL-5)post-treatment25.0 units on a scaleStandard Deviation 18.6
VETNETPTSD Checklist for the DSM-5 (PCL-5)3 months post treatment20 units on a scaleStandard Deviation 10.4
VETNETPTSD Checklist for the DSM-5 (PCL-5)mean change score pre to post-22.8 units on a scaleStandard Deviation 9
VETNETPTSD Checklist for the DSM-5 (PCL-5)mean change score pre to 3 months post-25.8 units on a scaleStandard Deviation 6.7
Primary

The Appetitive Aggression Scale (AAS)

This scale has two parts. Part 1 is a 17-item scale that asked participants to mark whether they have engaged in or witness specific violent acts. 15 of these items measure acts that could reflect appetitive aggression (.made another person scream in pain), and two are more clearly reactive (...defended yourself in a fight). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 is administered. Data from Part 2 is what is presented here. Part 2 is a 19-item scale that evaluates (yes or no) whether the participant enjoys engaging in violence. Only the first 15 items are scored because these reflect appetitive aggression (the last 4 items evaluate reactive aggression). Total score on Part 2 ranges from 0 to 15, with higher score reflecting greater appetitive aggression. Negative change score reflects decreases in appetitive aggression from baseline to post-treatment; positive change scores reflect increases.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETThe Appetitive Aggression Scale (AAS)mean change score baseline to post-treatment-0.8 units on a scaleStandard Deviation 0.84
VETNETThe Appetitive Aggression Scale (AAS)Baseline8.6 units on a scaleStandard Deviation 3.3
VETNETThe Appetitive Aggression Scale (AAS)post-treatment7.8 units on a scaleStandard Deviation 3.1
Secondary

Interpersonal Needs Questionnaire (INQ)

Based upon the Interpersonal Theory of Suicide (Joiner Jr et al., 2009), the INQ measures two proximal causes of the desire for suicide: Thwarted belongingness and Perceived burdensomeness. Participants rate each of the 15 items on a scale of 1 (not at all true for me) to 7 (very true for me). Total scores range from 15 to 105, with greater scores reflecting higher levels of suicide-related cognitions.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETInterpersonal Needs Questionnaire (INQ)Baseline48.6 units on a scaleStandard Deviation 17.7
VETNETInterpersonal Needs Questionnaire (INQ)post-treatment36.0 units on a scaleStandard Deviation 11.2
VETNETInterpersonal Needs Questionnaire (INQ)3 months post-treatment25.0 units on a scaleStandard Deviation 4.2
VETNETInterpersonal Needs Questionnaire (INQ)mean change score baseline to post-treatment-12.6 units on a scaleStandard Deviation 14.1
VETNETInterpersonal Needs Questionnaire (INQ)mean change score baseline to 3 months post-treatment-19.3 units on a scaleStandard Deviation 15.2
Secondary

Revised Conflict Tactics Scales (CTS2)

The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant. Participants answer how often these behaviors were perpetrated by them within a specified time period: 0 (never); 1 (once); 2 (twice); 3 (3-5 times); 4 (6-10 times); 5 (11-20 times); 6 (more than 20 times). The original CTS2 instructions will be modified to more appropriately reflect the goals of this study: 1) the target of the behavior will be expanded from partner to anyone; and 2) the time frame of the response will be reduced from one year to three months to detect potential changes associated with treatment. Two subscale scores were used for these analyses: Psychological Aggression (range = 0 to 48) and Physical Assault (range = 0 to 72), with higher scores reflecting greater use of aggression.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETRevised Conflict Tactics Scales (CTS2)Baseline Psychological Aggression8.6 units on a scaleStandard Deviation 5.9
VETNETRevised Conflict Tactics Scales (CTS2)Post-treatment psychological aggression8.6 units on a scaleStandard Deviation 7.3
VETNETRevised Conflict Tactics Scales (CTS2)3 months post-treatment psychological aggression1.8 units on a scaleStandard Deviation 2.2
VETNETRevised Conflict Tactics Scales (CTS2)mean change score psychological aggression baseline to post-treatment0.0 units on a scaleStandard Deviation 8.7
VETNETRevised Conflict Tactics Scales (CTS2)mean change score psychological aggression baseline to 3 months post-treatment-6.5 units on a scaleStandard Deviation 4.8
VETNETRevised Conflict Tactics Scales (CTS2)baseline physical assault3.4 units on a scaleStandard Deviation 7.1
VETNETRevised Conflict Tactics Scales (CTS2)post-treatment physical assault2.0 units on a scaleStandard Deviation 4.5
VETNETRevised Conflict Tactics Scales (CTS2)3 months post-treatment physical assault0.0 units on a scaleStandard Deviation 0
VETNETRevised Conflict Tactics Scales (CTS2)mean change score physical assault baseline to post-treatment-1.4 units on a scaleStandard Deviation 9.3
VETNETRevised Conflict Tactics Scales (CTS2)mean change score baseline to 3 months post-treatment-4.3 units on a scaleStandard Deviation 7.8
Secondary

The Moral Injury Events Scale (MIES)

The MIES is an 11-item scale that measures moral injury associated with experiences during military service. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11 to 66, with higher scores reflecting greater moral injury. Positive change scores reflect increase in moral injury from pre to post treatment; negative change scores reflect decrease in moral injury from pre to post treatment.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.

ArmMeasureGroupValue (MEAN)Dispersion
VETNETThe Moral Injury Events Scale (MIES)Baseline60.4 units on a scaleStandard Deviation 16.6
VETNETThe Moral Injury Events Scale (MIES)post-treatment63.6 units on a scaleStandard Deviation 25.1
VETNETThe Moral Injury Events Scale (MIES)3 months post-treatment61.3 units on a scaleStandard Deviation 14.7
VETNETThe Moral Injury Events Scale (MIES)mean change score baseline to post-treatment3.2 units on a scaleStandard Deviation 21.5
VETNETThe Moral Injury Events Scale (MIES)mean change score baseline to 3 months post-treatment-4.3 units on a scaleStandard Deviation 14.4
Secondary

Trauma-Related Guilt Index (TRGI)

Guided by appraisal theories of emotion, the 32-item TRGI is an index of guilt associated with the experience of trauma. Participants rate statements on a 5-point scale ranging from extremely true/extremely guilty (4) to not at all true/not guilty at all (0). Total scores range from 0 to 128, with higher scores reflecting greater trauma-related guilt.

Time frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)

Population: An error was made in administration of the TGRI such that only the first page of a two page measure was given to participants. None of the subscales of the TGRI could be computed with the first page items only. As such, no participant data could be analyzed for this measure.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026