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NCT07840079
Creative Art Teletherapy for Veterans With PTSD
Conditions: Post-Traumatic Stress Disorder F03.950.750.500 D013313
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: VA Office of Research and Development
Location: North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida
Summary
This project focuses on how the investigators can treat post-traumatic stress disorder (PTSD) with a Creative Art Teletherapy, Art-therapy Remote Treatment for Veterans Experiencing Trauma (ART-VET). Treatments for PTSD do not work well enough for many Veterans with PTSD. Many patients do not recover with current treatment methods. A core deficit in PTSD is an inability to feel safe in secure environments, and not to have flight, flight, or freeze behaviors. Unfortunately, many people have trouble with exposure-based psychotherapies and have trouble getting better or learning how to feel safer. Also, many rural Veterans are unable to attend treatment sessions in person.
The investigators plan to conduct a clinical trial of ART-VET, a promising 8 session (roughly weekly) teletherapy program, and the investigators will measure how well it works using many clinical and research measures before, during, and after participating in the therapy.
Eligibility Criteria
Inclusion Criteria:
* US Veterans with post-traumatic stress disorder (PTSD)
* Able to operate a pen \& keyboard
* Willing to participate in a Creative Art Teletherapy based intervention (including stable internet connection and compatible computing device)
* English proficiency (study materials are only available in English; participants must be able to read and write in English)
* Willing to provide informed consent. Consistent with ethical principles, all participants must be able to understand the nature of the experiment(s) they are volunteering to participate in, to understand their rights, risks, and potential benefits from their participation
* Stable pharmacotherapy
Exclusion Criteria:
* Major medical illness, in particular psychiatric, neurological or immunological (e.g., schizophrenia, organ failure, type-1 diabetes, significant auto-immune disease, etc.)
* Major uncorrectable sensory deficit, such as blindness or hearing loss
* Current drug or alcohol dependence or abuse
* History of greater than moderate traumatic brain injury (TBI) or have experienced a TBI more recent than 12 months
* Pregnancy
* Unstable pharmacotherapy
* Ongoing or planned psychotherapy. While ART-VET may be effective as an adjuvant to current standard of care psychotherapy, it would not be possible to disentangle the impacts of each in the present study. Potential participants with ongoing or planned psychotherapy will be offered the opportunity to initiate participation 3 months after completion if otherwise still eligible.
* Contraindications to participation in intervention or magnetic resonance imaging (MRI) (Disqualification by indication of a contraindication to participation in intervention such as an allergy to materials (unlikely), presence of metal or MRI-unsafe material, claustrophobia or other preclusion to participation in MRI, or disqualification from participation not otherwise subsumed above)
Source: ClinicalTrials.gov (NCT07840079). StuddyBuddy aggregates publicly available trial information.