Recruiting

Psychotherapy

Sponsor:

University of Texas at Austin

Code:

NCT06096740

Conditions

Post Traumatic Stress Disorder

Diminished Pleasure

Anhedonia

PTSD

Chronic PTSD

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Diminished Pleasure

Anhedonia

PTSD

Chronic PTSD

Study ID

NCT06096740

Start date

Jun 1, 2024

Status verified date

Sep, 2025

Completion date

May 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate Treatment

Those individuals randomized to immediate treatment will commence individual cognitive processing therapy (CPT) with an assigned study therapist, following the completion of baseline procedures.

placebo comparator: Delayed Treatment

Individuals randomized to the delayed treatment condition will be informed after randomization that their treatment will start in 6-8 weeks (the approximate period it will take for individuals in the immediate treatment arm to complete CPT and post-treatment assessments).

Interventions

Cognitive Processing Therapy

Cognitive processing therapy is a widely-utilized, empirically-supported treatment developed for PTSD. It is based on a cognitive theory of trauma which emphasizes the impact of trauma on belief systems and the development of "stuck points", which are unhealthy, unrealistic, and maladaptive ways of thinking that serve to maintain unhealthy beliefs and reinforce PTSD symptoms.

Primary outcome measure

  • Within subject beta coefficients for each parametrically modulated regressor of the Reinforcement Learning Task with Threat [ Time Frame: [10 weeks] ]

Central Contacts and Locations

Central contacts

Lauren Enten, B.S.A

512-495-5856fonzolab@austin.utexas.edu

Locations

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600

Recruiting

Austin, Texas, United States, 78712

Contacts

Lauren Enten, B.S.A.

512-495-5856fonzolab@austin.utexas.edu

Principal Investigator:

Greg Fonzo, Ph.D.

More Information

Sponsor

University of Texas at Austin

Last update posted

May 1, 2026

Last verified

Sep, 2025

Keywords

  • PTSD
  • Post Traumatic Stress
  • Emotional Numbing
  • CPT
  • Cognitive Processing Therapy
  • Therapy
  • Chronic PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-05-01.