Stress Disorders, Post-Traumatic
Conditions
Interventions
The purpose of this randomized clinical trial is to test the efficacy and safety of adding trans auricular vagus stimulation (taVNS) and repetitive transcranial magnetic stimulation (rTMS) neuromodula
gCBT + sham taVNS group (n=15)
gCBT + rTMS test group (n=15)
and gCBT + rTMS sham group (n=15). Before and after 20 neuromodulation sessions and 10 CBT sessions, the Posttraumatic Stress Disorder Checklist according to DSM-V (PCL-5), the International Trauma Qu
Sponsors
Escola Bahiana de Medicina e Saúde Pública
Universidade Católica de Petrópolis
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Symptoms of Post-traumatic stress disorder (PTSD) for at least six months.
Exclusion criteria
Exclusion criteria: Individuals with self-reported associated disorders that may interfere with outcomes (such as panic disorder, generalized anxiety, craving, personality disorders or cognitive deficits, and suicidal ideation), participants who miss any treatment session, whether cognitive behavioral group therapy (gCBT) or vagal or magnetic stimulation, and individuals who experience adverse reactions to the treatments tested will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the reduction of Post-Traumatic Stress Disorder (PTSD) symptoms after intervention with CBT-G associated with neuromodulation (taVNS or rTMS). Verified using the Posttraumatic Stress Disorder Checklist – DSM-V (PCL-5), applied before the first session and after the last session of the protocol. It will be observed whether there was a significant reduction in the total PCL-5 score, considering a cutoff point of 31 points and statistical analysis by paired t-test or Mann-Whitney test, with an alpha of 5% and a power of 80%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the reduction of PTSD-related symptoms according to ICD-11 criteria. Verified using the International Trauma Questionnaire (ITQ), applied before and after the protocol. It will be observed whether there was a reduction in scores in ITQ domains, indicating relevant clinical improvement.;To assess the reduction in anxiety levels associated with Post-Traumatic Stress Disorder (PTSD). Verified using the Beck Anxiety Inventory (BAI), applied before and after the interventions. It will be observed whether there was a reduction in the total BAI scores, with a change in category (e.g., from severe anxiety to moderate or mild).;To assess the improvement in sleep quality among participants. Verified using the Pittsburgh Sleep Quality Index (PSQI), applied before and after the protocol. It will be observed whether there was a reduction in the total PSQI scores, indicating an improvement in sleep quality. | — |
Countries
Brazil
Contacts
Public ContactCarlos Gonçalves
Escola Bahiana de Medicina e Saúde Pública
Outcome results
None listed