Clinical trial NCT03777553: Narrative Exposure Therapy (NET)
Official title: Narrative Exposure Therapy for Justice-Involved Veterans (D1298-W)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
criminal justice
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-12-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group pre/post trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Checklist for the DSM-5 (PCL-5)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
measure: Dimensions of Anger Reactions (DAR)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
measure: The Appetitive Aggression Scale (AAS)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
measure: Beck Depression Inventory (BDI-2)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
Secondary outcomes:
measure: The Moral Injury Events Scale (MIES)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
measure: Revised Conflict Tactics Scales (CTS2)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
measure: Trauma-Related Guilt Index (TRGI)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks)
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Elizabeth E Van Voorhees, PhD
role: PRINCIPAL_INVESTIGATOR
References: