Psychotherapy Effects on Reward Processing in PTSD

NCT ID: NCT06096740

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2029-05-01

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.

Detailed Description

The goals of the study are as follows:

1. Quantify, under conditions of safety (no threat), how PTSD psychotherapy alters reward circuit function and information encoding.

2. Identify how presence of threat augments PTSD psychotherapy effects on reward circuit function and information encoding.

3. (Exploratory). Identify how, following psychotherapy, changes in reward circuit function and information encoding under conditions of safety and threat are associated with improvements in symptoms of diminished positive affect (DimPA).

To accomplish the goals of the study, the investigators propose a neuroimaging-coupled, randomized clinical trial of immediate vs. delayed individual cognitive processing therapy (CPT) in individuals (N=120) with a primary diagnosis of chronic PTSD. Individuals will undergo, prior to randomization, clinical and neurobiological assessment with functional magnetic resonance imaging (fMRI) during completion of several reward processing paradigms. Two of these involve both a normal "safe" context and a threat context manipulation (threat of mild electrodermal shock that is periodically cycled throughout the task). Another paradigm involves making decisions to either approach reward or forego a reward when this decision conflicts with the likelihood of an aversive outcome. This is known as approach-avoidance conflict (AAC). This battery will provide a comprehensive characterization of reward processing behavior and circuit function and establish its relationship to treatment processes, as well as how such processes may vary as a function of threat.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy

Intervention Type: 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.

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).

Group Type: PLACEBO_COMPARATOR

Cognitive Processing Therapy

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CPT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Greg Fonzo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory A Fonzo, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

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

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Enten, B.S.A

Role: CONTACT

fonzolab@austin.utexas.edu

512-495-5856

Facility Contacts

Lauren Enten, B.S.A.

Role: primary

fonzolab@austin.utexas.edu

512-495-5856

Other Identifiers

STUDY00004746

Identifier Type: -

Identifier Source: org_study_id