The Effects of Trauma-focused Psychotherapy on Reward Circuitry Function and Information Encoding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Within subject beta coefficients for each parametrically modulated regressor of the Reinforcement Learning Task with Threat
研究概览
简要总结
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.
详细描述
The goals of the study are as follows:
- Quantify, under conditions of safety (no threat), how PTSD psychotherapy alters reward circuit function and information encoding.
- Identify how presence of threat augments PTSD psychotherapy effects on reward circuit function and information encoding.
- (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Able and willing to undergo functional magnetic resonance imaging (fMRI).
- •Willingness to participate in repeated assessments and as part of a delayed treatment group.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cognitive Processing Therapy (Behavioral)
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).
干预措施: Cognitive Processing Therapy (Behavioral)
结局指标
主要结局
Within subject beta coefficients for each parametrically modulated regressor of the Reinforcement Learning Task with Threat
时间窗: [10 weeks]
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).
次要结局
- 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])
研究者
Greg Fonzo
Assistant Professor
University of Texas at Austin