Trial Outcomes & Findings for Narrative Exposure Therapy (NET) (NCT NCT03777553)
NCT ID: NCT03777553
Last Updated: 2024-04-19
Results Overview
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.
COMPLETED
NA
9 participants
Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.
2024-04-19
Participant Flow
Participant milestones
| Measure |
VETNET
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Narrative Exposure Therapy (NET)
Baseline characteristics by cohort
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
PTSD Checklist for the DSM-5 (PCL-5)
baseline
|
47.8 units on a scale
Standard Deviation 15.0
|
|
PTSD Checklist for the DSM-5 (PCL-5)
post-treatment
|
25.0 units on a scale
Standard Deviation 18.6
|
|
PTSD Checklist for the DSM-5 (PCL-5)
3 months post treatment
|
20 units on a scale
Standard Deviation 10.4
|
|
PTSD Checklist for the DSM-5 (PCL-5)
mean change score pre to post
|
-22.8 units on a scale
Standard Deviation 9.0
|
|
PTSD Checklist for the DSM-5 (PCL-5)
mean change score pre to 3 months post
|
-25.8 units on a scale
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Dimensions of Anger Reactions (DAR)
Baseline
|
32 units on a scale
Standard Deviation 13.5
|
|
Dimensions of Anger Reactions (DAR)
Post-treatment
|
37.8 units on a scale
Standard Deviation 12.8
|
|
Dimensions of Anger Reactions (DAR)
3 months post-treatment
|
18.3 units on a scale
Standard Deviation 10.3
|
|
Dimensions of Anger Reactions (DAR)
mean change score from baseline to post-treatment
|
5.8 units on a scale
Standard Deviation 5.8
|
|
Dimensions of Anger Reactions (DAR)
mean change score from baseline to 3 months post-treatment
|
-9.5 units on a scale
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks)Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
The Appetitive Aggression Scale (AAS)
Baseline
|
8.6 units on a scale
Standard Deviation 3.3
|
|
The Appetitive Aggression Scale (AAS)
post-treatment
|
7.8 units on a scale
Standard Deviation 3.1
|
|
The Appetitive Aggression Scale (AAS)
mean change score baseline to post-treatment
|
-0.8 units on a scale
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Beck Depression Inventory (BDI-2)
mean of change score from baseline to 3-months post-treatment
|
-5.8 units on a scale
Standard Deviation 9.3
|
|
Beck Depression Inventory (BDI-2)
Baseline
|
19.2 units on a scale
Standard Deviation 5.5
|
|
Beck Depression Inventory (BDI-2)
post-treatment
|
13.2 units on a scale
Standard Deviation 7.9
|
|
Beck Depression Inventory (BDI-2)
3 months post-treatment
|
11.3 units on a scale
Standard Deviation 8.8
|
|
Beck Depression Inventory (BDI-2)
mean of change score from baseline to post-treatment
|
-6 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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. Positive change scores reflect increase in moral injury from pre to post treatment; negative change scores reflect decrease in moral injury from pre to post treatment.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
The Moral Injury Events Scale (MIES)
Baseline
|
60.4 units on a scale
Standard Deviation 16.6
|
|
The Moral Injury Events Scale (MIES)
post-treatment
|
63.6 units on a scale
Standard Deviation 25.1
|
|
The Moral Injury Events Scale (MIES)
3 months post-treatment
|
61.3 units on a scale
Standard Deviation 14.7
|
|
The Moral Injury Events Scale (MIES)
mean change score baseline to post-treatment
|
3.2 units on a scale
Standard Deviation 21.5
|
|
The Moral Injury Events Scale (MIES)
mean change score baseline to 3 months post-treatment
|
-4.3 units on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
The CTS2 includes 78 items measuring the use of psychological and physical attacks by the participant. Participants answer how often these behaviors were perpetrated by 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. Two subscale scores were used for these analyses: Psychological Aggression (range = 0 to 48) and Physical Assault (range = 0 to 72), with higher scores reflecting greater use of aggression.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Revised Conflict Tactics Scales (CTS2)
Baseline Psychological Aggression
|
8.6 units on a scale
Standard Deviation 5.9
|
|
Revised Conflict Tactics Scales (CTS2)
Post-treatment psychological aggression
|
8.6 units on a scale
Standard Deviation 7.3
|
|
Revised Conflict Tactics Scales (CTS2)
3 months post-treatment psychological aggression
|
1.8 units on a scale
Standard Deviation 2.2
|
|
Revised Conflict Tactics Scales (CTS2)
mean change score psychological aggression baseline to post-treatment
|
0.0 units on a scale
Standard Deviation 8.7
|
|
Revised Conflict Tactics Scales (CTS2)
mean change score psychological aggression baseline to 3 months post-treatment
|
-6.5 units on a scale
Standard Deviation 4.8
|
|
Revised Conflict Tactics Scales (CTS2)
baseline physical assault
|
3.4 units on a scale
Standard Deviation 7.1
|
|
Revised Conflict Tactics Scales (CTS2)
post-treatment physical assault
|
2.0 units on a scale
Standard Deviation 4.5
|
|
Revised Conflict Tactics Scales (CTS2)
3 months post-treatment physical assault
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Revised Conflict Tactics Scales (CTS2)
mean change score physical assault baseline to post-treatment
|
-1.4 units on a scale
Standard Deviation 9.3
|
|
Revised Conflict Tactics Scales (CTS2)
mean change score baseline to 3 months post-treatment
|
-4.3 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks)Population: An error was made in administration of the TGRI such that only the first page of a two page measure was given to participants. None of the subscales of the TGRI could be computed with the first page items only. As such, no participant data could be analyzed for this measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change in total score from baseline to end of treatment (approximately 10-12 weeks), and baseline to 3 months post-treatment.Population: Veterans with recent justice involvement including current probation, parole, or house arrest, or having been released from jail or prison within the past 1 year, and who met criteria for posttraumatic stress disorder at baseline.
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.
Outcome measures
| Measure |
VETNET
n=5 Participants
Narrative Exposure Therapy for Justice-Involved Veterans: Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
|
|---|---|
|
Interpersonal Needs Questionnaire (INQ)
Baseline
|
48.6 units on a scale
Standard Deviation 17.7
|
|
Interpersonal Needs Questionnaire (INQ)
post-treatment
|
36.0 units on a scale
Standard Deviation 11.2
|
|
Interpersonal Needs Questionnaire (INQ)
3 months post-treatment
|
25.0 units on a scale
Standard Deviation 4.2
|
|
Interpersonal Needs Questionnaire (INQ)
mean change score baseline to post-treatment
|
-12.6 units on a scale
Standard Deviation 14.1
|
|
Interpersonal Needs Questionnaire (INQ)
mean change score baseline to 3 months post-treatment
|
-19.3 units on a scale
Standard Deviation 15.2
|
Adverse Events
VETNET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth Van Voorhees
Durham Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place