Psychotherapy Effects on Reward Processing in PTSD

Официальное название

The Effects of Trauma-focused Psychotherapy on Reward Circuitry Function and Information Encoding

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Within-subject BOLD contrast for unexpected absence of juice vs. expected absence of juice (negative temporal Prediction Errors) for safe and threat contexts. [Срок оценки: [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. [Срок оценки: [10 weeks]]
• Within subject beta coefficients for each parametrically modulated regressor of an approach avoidance conflict task. [Срок оценки: [10 weeks]]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT06096740 · STUDY00004746

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗