Narrative Exposure Therapy (NET)

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03777553
Collaborator
(none)
5
1
1
20.4
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a single group pre/post trial.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)
Actual Study Start Date :
Jun 13, 2019
Actual Primary Completion Date :
Feb 24, 2021
Actual Study Completion Date :
Feb 24, 2021

Arms and Interventions

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 Names:
  • VETNET
  • Outcome Measures

    Primary Outcome Measures

    1. PTSD Checklist for the DSM-5 (PCL-5) [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) [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) [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) [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) [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) [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) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Durham VA Medical Center, Durham, NC Durham North Carolina United States 27705

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Elizabeth E Van Voorhees, PhD, Durham VA Medical Center, Durham, NC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03777553
    Other Study ID Numbers:
    • D1298-W-1
    First Posted:
    Dec 17, 2018
    Last Update Posted:
    Mar 4, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 4, 2021