NCT03777553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 19, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

December 12, 2018

Results QC Date

May 5, 2022

Last Update Submit

April 17, 2024

Conditions

Keywords

posttraumatic stress disordercriminal justiceVeterans

Outcome Measures

Primary Outcomes (4)

  • 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.

    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)

    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.

    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)

    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.

    Change in total score from baseline to end of treatment (approximately 10-12 weeks)

  • 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.

    Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Secondary Outcomes (4)

  • The Moral Injury Events Scale (MIES)

    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)

    Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

  • Trauma-Related Guilt Index (TRGI)

    Change in total score from baseline to end of treatment (approximately 10-12 weeks)

  • Interpersonal Needs Questionnaire (INQ)

    Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.

Study Arms (1)

VETNET

EXPERIMENTAL

Narrative Exposure Therapy for Justice-Involved Veterans

Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans

Interventions

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

Also known as: VETNET
VETNET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Elizabeth Van Voorhees
Organization
Durham Veterans Affairs Medical Center

Study Officials

  • Elizabeth E Van Voorhees, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single group pre/post trial.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 17, 2018

Study Start

June 13, 2019

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

April 19, 2024

Results First Posted

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations