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Narrative Exposure Therapy (NET) (NET)

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ClinicalTrials.gov Identifier: NCT03777553
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single group pre/post trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VETNET
Narrative Exposure Therapy for Justice-Involved Veterans
Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans
Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
Other Name: VETNET




Primary Outcome Measures :
  1. PTSD Checklist for the DSM-5 (PCL-5) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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.

  2. Dimensions of Anger Reactions (DAR) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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.

  3. 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. 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.

  4. Beck Depression Inventory (BDI-2) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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 :
  1. The Moral Injury Events Scale (MIES) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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.

  2. Revised Conflict Tactics Scales (CTS2) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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.

  3. 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.

  4. Interpersonal Needs Questionnaire (INQ) [ Time Frame: Change in total score from baseline to end of treatment (approximately 10-12 weeks) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777553


Contacts
Contact: Angela C Kirby, MS (919) 286-0411 ext 7456 angela.kirby@va.gov
Contact: Elizabeth E Van Voorhees, PhD (919) 286-0411 ext 6435 Elizabeth.VanVoorhees@va.gov

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Angela C Kirby, MS    919-286-0411 ext 7456    angela.kirby@va.gov   
Contact: Elizabeth E Van Voorhees, PhD    (919) 286-0411 ext 6435    Elizabeth.VanVoorhees@va.gov   
Principal Investigator: Elizabeth E Van Voorhees, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Elizabeth E Van Voorhees, PhD Durham VA Medical Center, Durham, NC

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03777553     History of Changes
Other Study ID Numbers: D1298-W-1
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by VA Office of Research and Development:
posttraumatic stress disorder
criminal justice
Veterans

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders