Psychotherapy Effects on Reward Processing in PTSD

NCT06096740 | Recruiting DMC

• 1 other identifier: STUDY00004746
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Diminished Pleasure; Post Traumatic Stress Disorder; Anhedonia; PTSD; Chronic PTSD; Chronic Post-Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Within subject beta coefficients for each parametrically modulated regressor of the Reinforcement Learning Task with Threat

  The changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation associated with individual trial-by-trial reinforcement learning computational model parameters at the time of choice valuation (expected reward value during safe contexts and expected reward value during threat contexts) and choice outcome (reward prediction errors during safe contexts and reward prediction errors during threat contexts).

  [10 weeks]

Secondary Outcomes (3)

• Within-subject BOLD contrast for unexpected absence of juice vs. expected absence of juice (negative temporal Prediction Errors) for safe and threat contexts.

  [10 weeks]

• Within-subject BOLD contrast for the unexpected delivery of juice vs. the expected delivery of juice (positive temporal Prediction Errors) for safe and threat contexts.

  [10 weeks]

• Within subject beta coefficients for each parametrically modulated regressor of an approach avoidance conflict task.

  [10 weeks]

Other Outcomes (2)

• Change in total score of the Clinician Administered PTSD Scale for DSM-5 from baseline to 10 weeks

  10 weeks

• Change in total score of the PTSD Checklist for DSM-5 from baseline to 10 weeks

  10 weeks

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

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

Behavioral: Cognitive Processing Therapy

Delayed Treatment

PLACEBO COMPARATOR

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).

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Also known as: CPT

Delayed Treatment; Immediate Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

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

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anhedonia

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory A Fonzo, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Enten, B.S.A

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: As participants will necessarily be aware of their arm assignment, symptom raters (research assistants) and study therapists will be blinded to participant arm assignment to reduce risk of ascertainment bias.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomization will be stratified based upon baseline presence/absence of MDD and will occur using pre-specified block randomization with randomly-sized blocks of either 4 or 6 to ensure near-equal distribution of participants with and without comorbid MDD between the two arms over time, while avoiding the ability for study personnel to predict treatment assignment of the next participant. Blocks will involve various orderings of participant assignment, each block will be assigned a number, and a random list generator will then order the block sequences prior to the start of the study. This will ensure equal numbers of participants with and without MDD are assigned to each treatment condition and limit predictability of assignment.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)