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Behavioral Intervention

tDCS + Written Exposure Therapy for PTSD

N/A
Recruiting
Led By Casey Straud, PsyD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals between the ages of 18 and 65 years old at time of screening.
PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 9 weeks (one month post study treatment)
Awards & highlights

Study Summary

This trial will study whether tDCS, a noninvasive brain stimulation technique, is safe and feasible to use in combination with Written Exposure Therapy (WET) to treat PTSD.

Who is the study for?
This trial is for adults aged 18-65 with PTSD who can read, write, and speak English. It's not suitable for those pregnant or breastfeeding, with significant brain injuries or neurological disorders, using other brain stimulation techniques or trauma-focused therapy for PTSD, recent changes in certain medications, skin conditions where electrodes are placed, electronic implants/metallic objects (except dental), history of seizures/epilepsy, severe substance use disorder, immediate psychiatric risk requiring higher care level.Check my eligibility
What is being tested?
The study tests if a noninvasive brain stimulation technique called transcranial direct current stimulation (tDCS) combined with Written Exposure Therapy (WET) is safe and effective for treating PTSD. Participants will either receive the actual tDCS treatment or a sham (fake) version alongside WET to compare outcomes.See study design
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode site on the scalp like itching or tingling during application and mild headache post-treatment. There's also a small risk of mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with PTSD by a professional.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 9 weeks (one month post study treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 9 weeks (one month post study treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of reported adverse events reported
Number of subjects that completed all 5 WET sessions
Posttraumatic Stress Disorder Checklist (PCL-5)
Secondary outcome measures
Clinician Administer PTSD Scale-5 (CAPS-5)
Generalize Anxiety Disorder-7 (GAD)
Patient Health Questionnaire-9 (PHQ)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS plus WETExperimental Treatment2 Interventions
Subjects will receive transcranial direct current stimulation (tDCS) plus written exposure therapy (WET)
Group II: Sham plus WETPlacebo Group2 Interventions
Subjects will receive sham transcranial direct current stimulation (tDCS) treatment plus written exposure therapy (WET)

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,048 Total Patients Enrolled
Casey Straud, PsyDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
1 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Written Exposure Therapy (WET) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05419999 — N/A
Post-Traumatic Stress Disorder Research Study Groups: tDCS plus WET, Sham plus WET
Post-Traumatic Stress Disorder Clinical Trial 2023: Written Exposure Therapy (WET) Highlights & Side Effects. Trial Name: NCT05419999 — N/A
Written Exposure Therapy (WET) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419999 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a way for me to become involved in this research experiment?

"For this clinical trial, 40 volunteers aged 18 to 65 with diagnosis of moral injury and PTSD as assessed by CAPS-5 are solicited. Moreover, these individuals must be able to comprehend English written or spoken text."

Answered by AI

What are the primary aims of this experiment?

"The primary assessment of this 5 week trial is the Posttraumatic Stress Disorder Checklist (PCL-5). Secondary assessments include Patient Health Questionnaire-9 (PHQ), Generalize Anxiety Disorder-7 (GAD) and Posttraumatic Cognitions Inventory (PTCI). PHQ evaluates affective and somatic symptoms related to depression, GAD measures generalised anxiety symptomology, while PTCI assesses how an individual views a traumatic event."

Answered by AI

Are there vacancies in this experimental procedure for participants?

"According to clinicaltrials.gov, this trial has been inactive since November 3rd 2022 and is not actively enrolling participants. However, 417 other trials are presently accepting patients."

Answered by AI

Are individuals of all ages welcome to join this scientific endeavor?

"The upper and lower age criterion for this study mandates that all participants must be of legal adulthood, yet under the retirement age."

Answered by AI
~7 spots leftby Jul 2024