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Narrative Exposure Therapy (NET) (NET)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Exposure Therapy for Justice-Involved Veterans
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, criminal justice, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VETNET

Arm Description

Narrative Exposure Therapy for Justice-Involved Veterans

Outcomes

Primary Outcome Measures

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.
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.
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. Fifteen of these items measure acts that could reflect appetitive aggression (e.g. ".made another person scream in pain"), and two are more clearly reactive (e.g. "...defended yourself in a fight"). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 will be administered. Part 2 is a 19-item scale that asks participants to rate their perceptions of aggression on a 5-point Likert scale ranging from 0 (disagree) to 4 (agree). Part 2 of the scale has been demonstrated to have acceptable reliability, and has been shown to measure a construct distinct from other conceptualizations of aggression. Total score range is 0 to 76, with higher score reflecting greater appetitive aggression.
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.

Secondary Outcome Measures

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.
Revised Conflict Tactics Scales (CTS2)
The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant, as well as the experience of such attacks. Participants answer how often these behaviors were perpetrated by or against 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. The CTS2 includes the following subscales: Negotiation, Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Physical Assault scores range from 0 to 72, with higher scores reflecting higher frequency of assaultive behavior.
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.
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.

Full Information

First Posted
December 12, 2018
Last Updated
March 3, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03777553
Brief Title
Narrative Exposure Therapy (NET)
Acronym
NET
Official Title
Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder, criminal justice, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group pre/post trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VETNET
Arm Type
Experimental
Arm Description
Narrative Exposure Therapy for Justice-Involved Veterans
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy for Justice-Involved Veterans
Other Intervention Name(s)
VETNET
Intervention Description
Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
Primary Outcome Measure Information:
Title
PTSD Checklist for the DSM-5 (PCL-5)
Description
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.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Title
Dimensions of Anger Reactions (DAR)
Description
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.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Title
The Appetitive Aggression Scale (AAS)
Description
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. Fifteen of these items measure acts that could reflect appetitive aggression (e.g. ".made another person scream in pain"), and two are more clearly reactive (e.g. "...defended yourself in a fight"). If a participant endorses having engaged in any of the 15 potentially appetitive aggressive behaviors, then Part 2 will be administered. Part 2 is a 19-item scale that asks participants to rate their perceptions of aggression on a 5-point Likert scale ranging from 0 (disagree) to 4 (agree). Part 2 of the scale has been demonstrated to have acceptable reliability, and has been shown to measure a construct distinct from other conceptualizations of aggression. Total score range is 0 to 76, with higher score reflecting greater appetitive aggression.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Title
Beck Depression Inventory (BDI-2)
Description
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.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Secondary Outcome Measure Information:
Title
The Moral Injury Events Scale (MIES)
Description
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.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Title
Revised Conflict Tactics Scales (CTS2)
Description
The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant, as well as the experience of such attacks. Participants answer how often these behaviors were perpetrated by or against 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. The CTS2 includes the following subscales: Negotiation, Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Physical Assault scores range from 0 to 72, with higher scores reflecting higher frequency of assaultive behavior.
Time Frame
Change in total score from baseline to end of treatment (approximately 10-12 weeks)
Title
Trauma-Related Guilt Index (TRGI)
Description
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)
Title
Interpersonal Needs Questionnaire (INQ)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth E Van Voorhees, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Narrative Exposure Therapy (NET)

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