Adults 18 to 70, any sex, with Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total ScorePrimary· Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on how much the symptom bothered the respondent in the past month (0 = "not at all bothered by" to 4 = "extremely bothered "). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. PCL-5 scores at 1 month was the primary symptom outcome measure for this study.
Baseline
Group
Value
95% CI
Active Stimulation
48.6
± 12.1
Sham Stimulation
45.0
± 11.9
Midpoint
Group
Value
95% CI
Active Stimulation
38.5
± 14.4
Sham Stimulation
41.3
± 15.1
Endpoint
Group
Value
95% CI
Active Stimulation
36.0
± 15.4
Sham Stimulation
38.9
± 15.1
1 Month Follow-Up
Group
Value
95% CI
Active Stimulation
31.4
± 17.8
Sham Stimulation
37.9
± 16.6
3 Month Follow-Up
Group
Value
95% CI
Active Stimulation
21.2
± 12.6
Sham Stimulation
32.3
± 17.1
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)Primary· Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up
The 16-item QLESQ (short form) evaluates quality of life and other areas of change related to functioning outside of symptom domains (e.g., physical health, mood, leisure time activities, social relationships, etc.). Items are rated on how satisfied the respondent has been in the past week (1 = "very poor" to 5 = "very good "). A total raw score (range: 16-80). Higher outcomes indicate better quality of life, greater enjoyment, and satisfaction.
Baseline
Group
Value
95% CI
Active Stimulation
35.9
± 8.9
Sham Stimulation
39.2
± 9.8
Endpoint
Group
Value
95% CI
Active Stimulation
39.2
± 10.2
Sham Stimulation
41.6
± 9.2
1 month follow-up
Group
Value
95% CI
Active Stimulation
40.7
± 10.3
Sham Stimulation
41.0
± 8.5
3-month follow-up
Group
Value
95% CI
Active Stimulation
44.3
± 9.6
Sham Stimulation
47.1
± 10.1
Psychophysiology (Skin Conductance Reactivity; SCR)Primary· Measured during each tDCS+VR session, each session up to 1 hour
Psychophysiology will include skin conductance reactivity to specific trauma context virtual reality (VR) cues presented in the VR scenario. SCR to VR events will be measured by the phasic responses that occur after the presentation of discreet VR events. SCR will be compared from baseline to end of tDCS+VR, to correlate these measures and evaluate changes attributable to active tDCS+VR compared to sham.
VR Session 1
Group
Value
95% CI
Active Stimulation
0.742
± 0.093
Sham Stimulation
0.64
± 0.093
VR Session 2
Group
Value
95% CI
Active Stimulation
0.596
± 0.095
Sham Stimulation
0.503
± 0.092
VR Session 3
Group
Value
95% CI
Active Stimulation
0.48
± 0.095
Sham Stimulation
0.539
± 0.093
VR Session 4
Group
Value
95% CI
Active Stimulation
0.458
± 0.096
Sham Stimulation
0.475
± 0.093
VR Session 5
Group
Value
95% CI
Active Stimulation
0.295
± 0.095
Sham Stimulation
0.492
± 0.094
VR Session 6
Group
Value
95% CI
Active Stimulation
0.441
± 0.096
Sham Stimulation
0.492
± 0.094
Inventory of Depressive Symptomatology Self-Report (IDSSR)Secondary· Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up
The 28-item IDSSR is a self-report measure of depressive symptom severity. Each item is rated on a scale of 0 to 3 by the participant for a total minimum score of 0 and a maximum score of 84. A higher score on the IDSSR indicates increased depressive symptom severity.
Baseline
Group
Value
95% CI
Active Stimulation
41.6
± 12.0
Sham Stimulation
38.6
± 13.0
Midpoint
Group
Value
95% CI
Active Stimulation
35.5
± 10.7
Sham Stimulation
35.3
± 13.4
Endpoint
Group
Value
95% CI
Active Stimulation
34.2
± 15.1
Sham Stimulation
34.8
± 14.5
1 Month Follow-Up
Group
Value
95% CI
Active Stimulation
30.5
± 16.2
Sham Stimulation
32.3
± 15.5
3 Month Follow-Up
Group
Value
95% CI
Active Stimulation
23.4
± 12.7
Sham Stimulation
27.1
± 14.8
Social and Occupational Function Scale (SOFAS)Secondary· Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up
The SOFAS is a scale that focuses on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Any impairment in social and occupational functioning that is due to general medical conditions is considered in making the SOFAS rating. The SOFAS is usually used to rate functioning for the current period (i.e., the level of functioning at the time of the evaluation). Scores range from 0 to 100, with higher scores indicating better social and occupational functioning.
Baseline
Group
Value
95% CI
Active Stimulation
40.5
± 9.7
Sham Stimulation
43.0
± 11.2
Endpoint
Group
Value
95% CI
Active Stimulation
47.2
± 14.7
Sham Stimulation
48.0
± 12.2
1 Month Follow-Up
Group
Value
95% CI
Active Stimulation
53.1
± 13.8
Sham Stimulation
54.1
± 15.4
3 Month Follow-Up
Group
Value
95% CI
Active Stimulation
67.2
± 8.3
Sham Stimulation
62.2
± 15.3
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)Secondary· Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up
The CAPS-5 is the gold standard in clinician-assessed PTSD symptoms. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subty
Baseline
Group
Value
95% CI
Active Stimulation
44.8
± 8.2
Sham Stimulation
40.5
± 8.1
Endpoint
Group
Value
95% CI
Active Stimulation
40.4
± 11.2
Sham Stimulation
37.1
± 9.2
1 Month Follow-Up
Group
Value
95% CI
Active Stimulation
34.1
± 14.7
Sham Stimulation
36.1
± 12.6
3 Month Follow-Up
Group
Value
95% CI
Active Stimulation
22.7
± 13.9
Sham Stimulation
31
± 11.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to three months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study tests the efficacy of combining non-invasive brain stimulation, called transcranial direct current stimulation (tDCS), with virtual reality exposure as a treatment for Veterans with chronic posttraumatic stress disorder (PTSD). Investigators tested whether this intervention improves PTSD symptoms and improves quality of life. Results from this study may be used to develop a new non-medication approach to treating chronic PTSD.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 13 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03372460.