- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777553
Narrative Exposure Therapy (NET) (NET)
Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: VETNET
Narrative Exposure Therapy for Justice-Involved Veterans
|
Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist for the DSM-5 (PCL-5)
Time Frame: 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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
|
|
Dimensions of Anger Reactions (DAR)
Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
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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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
|
|
The Appetitive Aggression Scale (AAS)
Time Frame: 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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks)
|
|
Beck Depression Inventory (BDI-2)
Time Frame: 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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma-Related Guilt Index (TRGI)
Time Frame: 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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks)
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The Moral Injury Events Scale (MIES)
Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
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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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
|
|
Revised Conflict Tactics Scales (CTS2)
Time Frame: 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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
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Interpersonal Needs Questionnaire (INQ)
Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
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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.
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Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth E Van Voorhees, PhD, Durham VA Medical Center, Durham, NC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1298-W-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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