NCT06096740 Psychotherapy Effects on Reward Processing in PTSD
| NCT ID | NCT06096740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-06-01 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.
Eligibility Criteria
Inclusion Criteria: * English as primary language, and comprehension suitable to understand experimenter instructions. * Current and chronic syndromic PTSD, defined as being exposed to a DSM-5 Criterion A traumatic event, with the presence DSM-5 qualifying PTSD symptoms for at least 3 months, as assessed by the Clinician-Administered PTSD Scale for DSM-5. * Able and willing to undergo functional magnetic resonance imaging (fMRI). * Willingness to participate in repeated assessments and as part of a delayed treatment group. Exclusion Criteria: * Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview. * Active substance dependence within the past 6 months as evidenced by clinical interview. * Current regular psychiatric medication use (i.e. antidepressants), except for as-needed benzodiazepine or opiate medication no more than three times per week, on average, or for short-duration stimulant medication for attention deficit hyperactivity disorder that can be skipped within 24 hours of study visits. * A recent (\<6 months) suicide attempt or current active ideation with intent. * Unremovable ferrous metal in body. * History of neurological disorder, stroke, seizures/convulsions (except febrile seizures in childhood), epilepsy, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, or thyroid disorder. * Anyone who is pregnant or trying to become pregnant. * Current or past year (\> 3 sessions), psychotherapy with a prominent exposure or cognitive restructuring component. * Previous or current (es)ketamine treatment and/ or brain stimulation/neuromodulation treatment. * Other ongoing treatment that is likely to confound experimental effects. * Previous penetrating head injury/traumatic brain injury. Mild-to-moderate traumatic brain injury without penetrating injury is allowable.
Contact & Investigator
Gregory A Fonzo, PhD
PRINCIPAL INVESTIGATOR
The University of Texas at Austin
Frequently Asked Questions
Who can join the NCT06096740 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06096740 currently recruiting?
Yes, NCT06096740 is actively recruiting participants. Contact the research team at fonzolab@austin.utexas.edu for enrollment information.
Where is the NCT06096740 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06096740 clinical trial?
NCT06096740 is sponsored by University of Texas at Austin. The principal investigator is Gregory A Fonzo, PhD at The University of Texas at Austin. The trial plans to enroll 120 participants.