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
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Behavioral: Narrative Exposure Therapy for Justice-Involved Veterans||Not Applicable|
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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Angela C Kirby, MS||(919) 286-0411 ext firstname.lastname@example.org|
|Contact: Elizabeth E Van Voorhees, PhD||(919) 286-0411 ext 6435||Elizabeth.VanVoorhees@va.gov|
|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 email@example.com|
|Contact: Elizabeth E Van Voorhees, PhD (919) 286-0411 ext 6435 Elizabeth.VanVoorhees@va.gov|
|Principal Investigator: Elizabeth E Van Voorhees, PhD|
|Principal Investigator:||Elizabeth E Van Voorhees, PhD||Durham VA Medical Center, Durham, NC|