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CompletedNCT03777553NETUpdated Apr 19, 2024Results posted

Narrative Exposure Therapy (NET)

An interventional study of Narrative Exposure Therapy for Justice-Involved Veterans in Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Posttraumatic Stress Disorder

Keywords

  • posttraumatic stress disorder
  • criminal justice
  • Veterans
03

In context

Stress Disorders, Post-Traumatic

2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,768 studies on the registry; 393 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    VETNET

    Narrative Exposure Therapy for Justice-Involved Veterans

    Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans

Interventions

  • BehavioralNarrative Exposure Therapy for Justice-Involved Veterans

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

    Also known as: VETNET

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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.

07

Results

Posted Apr 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneVETNET
Started9
Completed5
Not completed4

Outcome measures

PrimaryPTSD 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.
Reported as:
Mean · units on a scale
PTSD Checklist for the DSM-5 (PCL-5)
units on a scaleVETNET
baseline47.8 ± 15.0
post-treatment25.0 ± 18.6
3 months post treatment20 ± 10.4
mean change score pre to post-22.8 ± 9.0
mean change score pre to 3 months post-25.8 ± 6.7
PrimaryDimensions 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.
Reported as:
Mean · units on a scale
Dimensions of Anger Reactions (DAR)
units on a scaleVETNET
Baseline32 ± 13.5
Post-treatment37.8 ± 12.8
3 months post-treatment18.3 ± 10.3
mean change score from baseline to post-treatment5.8 ± 5.8
mean change score from baseline to 3 months post-treatment-9.5 ± 5.8
PrimaryThe 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)
Reported as:
Mean · units on a scale
The Appetitive Aggression Scale (AAS)
units on a scaleVETNET
Baseline8.6 ± 3.3
post-treatment7.8 ± 3.1
mean change score baseline to post-treatment-0.8 ± 0.84
PrimaryBeck 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.
Reported as:
Mean · units on a scale
Beck Depression Inventory (BDI-2)
units on a scaleVETNET
Baseline19.2 ± 5.5
post-treatment13.2 ± 7.9
3 months post-treatment11.3 ± 8.8
mean of change score from baseline to post-treatment-6 ± 6.6
mean of change score from baseline to 3-months post-treatment-5.8 ± 9.3
SecondaryThe 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.
Reported as:
Mean · units on a scale
The Moral Injury Events Scale (MIES)
units on a scaleVETNET
Baseline60.4 ± 16.6
post-treatment63.6 ± 25.1
3 months post-treatment61.3 ± 14.7
mean change score baseline to post-treatment3.2 ± 21.5
mean change score baseline to 3 months post-treatment-4.3 ± 14.4
SecondaryRevised 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.
Reported as:
Mean · units on a scale
Revised Conflict Tactics Scales (CTS2)
units on a scaleVETNET
Baseline Psychological Aggression8.6 ± 5.9
Post-treatment psychological aggression8.6 ± 7.3
3 months post-treatment psychological aggression1.8 ± 2.2
mean change score psychological aggression baseline to post-treatment0.0 ± 8.7
mean change score psychological aggression baseline to 3 months post-treatment-6.5 ± 4.8
baseline physical assault3.4 ± 7.1
post-treatment physical assault2.0 ± 4.5
3 months post-treatment physical assault0.0 ± 0.0
mean change score physical assault baseline to post-treatment-1.4 ± 9.3
mean change score baseline to 3 months post-treatment-4.3 ± 7.8
SecondaryTrauma-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)

No measurements were reported for this outcome.

SecondaryInterpersonal 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.
Reported as:
Mean · units on a scale
Interpersonal Needs Questionnaire (INQ)
units on a scaleVETNET
Baseline48.6 ± 17.7
post-treatment36.0 ± 11.2
3 months post-treatment25.0 ± 4.2
mean change score baseline to post-treatment-12.6 ± 14.1
mean change score baseline to 3 months post-treatment-19.3 ± 15.2

Adverse events

Collected over 6 months: Veterans completed a baseline assessment, 10-12 weekly sessions of treatment over approximately 2 1/2 to 3 months, a post-treatment assessment, and then completed questionnaires at 3 months post-treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VETNET0/9 (0%)0/9 (0%)0/9 (0%)

Baseline characteristics

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 PTSD at the time of study entry.

Age, Categorical
Age, Categorical(Participants)VETNET
<=18 years0
Between 18 and 65 years5
>=65 years0
Age, Continuous
Age, Continuous(years)VETNET
Mean44.2 ± 9.18
Sex: Female, Male
Sex: Female, Male(Participants)VETNET
Female0
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VETNET
Hispanic or Latino0
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VETNET
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White2
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)VETNET
United States5
08

Study locations

1 site
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina 27705, United States
09

References and documents

Study documents

  • Study protocol · Apr 21, 2020
  • Informed consent form · Mar 13, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03777553
Responsible party
Sponsor
First posted
Dec 17, 2018
Start date
Jun 13, 2019
Primary completion
Feb 24, 2021
Completion
Feb 24, 2021
Results posted
Apr 19, 2024
Last update
Apr 19, 2024

Study contacts

Elizabeth E Van Voorhees, PhD
principal investigator · Durham VA Medical Center, Durham, NC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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