Trial results for a study investigating transcranial direct current stimulation (tDCS) combined with Written Exposure Therapy (WET) for Post Traumatic Stress Disorder (PTSD) were posted on ClinicalTrials.gov on 2025-05-29, involving 25 participants.
Background
Post Traumatic Stress Disorder (PTSD) is a mental health condition that can develop after exposure to traumatic events. Effective treatments are crucial for managing its debilitating symptoms. Written Exposure Therapy (WET) is a recognized behavioral therapy for PTSD. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been explored for various neurological and psychiatric conditions. This study aimed to evaluate the safety, feasibility, and potential psychological and physiological benefits of combining tDCS with WET for individuals with PTSD.
Trial design
This completed study, designated as Phase NA, enrolled 25 participants with Post Traumatic Stress Disorder. The trial's primary objective was to evaluate the safety, feasibility, and psychological and physiological treatment benefits of tDCS when delivered in combination with Written Exposure Therapy (WET). Participants were assigned to either a tDCS Plus WET group or a Sham Plus WET group, serving as a comparator. The intervention involved transcranial direct current stimulation alongside the behavioral therapy.
Key results
The trial reported key measurements related to PTSD symptom severity and treatment completion:
- Posttraumatic Stress Disorder Checklist (PCL-5) (score on a scale):
- Initial mean score for the tDCS Plus WET group was 44.30 (Standard Error 3.74).
- Initial mean score for the Sham Plus WET group was 43.38 (Standard Error 3.56).
- Final mean score for the tDCS Plus WET group was 22.51 (Standard Error 3.98).
- Final mean score for the Sham Plus WET group was 25.11 (Standard Error 3.78).
- Clinician Administer PTSD Scale-5 (CAPS-5) (score on a scale):
- Initial mean score for the tDCS Plus WET group was 35.95 (Standard Error 2.01).
- Initial mean score for the Sham Plus WET group was 35.08 (Standard Error 1.93).
- Final mean score for the tDCS Plus WET group was 14.65 (Standard Error 2.31).
- Final mean score for the Sham Plus WET group was 15.89 (Standard Error 2.09).
- Patient Health Questionnaire-9 (PHQ) (score on a scale):
- The tDCS Plus WET group had a mean score of 15.58 (Standard Error 1.82).
- The Sham Plus WET group had a mean score of 15.54 (Standard Error 1.75).
- Number of Subjects That Completed All 5 WET Sessions (Participants):
- 12 participants in the tDCS Plus WET group completed all sessions.
- 12 participants in the Sham Plus WET group completed all sessions.
What this means
The posted results indicate that both the tDCS Plus WET and Sham Plus WET groups experienced reductions in PTSD symptom severity as measured by the PCL-5 and CAPS-5 scores from initial to final assessments. The tDCS Plus WET group showed slightly lower final mean scores on both the PCL-5 (22.51 vs 25.11) and CAPS-5 (14.65 vs 15.89) compared to the Sham Plus WET group. Completion rates for the WET sessions were identical across both groups, with 12 participants in each arm completing all sessions. These findings provide preliminary data on the feasibility and potential benefits of combining tDCS with Written Exposure Therapy for PTSD, though no comparative statistical analyses were provided to determine significance.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05419999, titled 'Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy', were posted on 2025-05-29 on clinicaltrials.gov.