Gaze-Contingent Music Reward Treatment (GC-MRT) for PTSD
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 75
- 主要终点
- Changes in illness severity and improvement over time
研究概览
简要总结
The present study is a double-blind trial that seeks to examine the feasibility, acceptability, and efficacy of a recently developed eye-tracking-based, gaze-contingent music reward therapy (GC-MRT) in individuals with posttraumatic stress disorder (PTSD).
The specific aims of this study are to: (1) examine the efficacy of GC-MRT in PTSD; and (2) elucidate its underpinnings (i.e. attention control, reward processes, and exposure via counter-conditioning).
The investigators hypothesize that:
- GC-MRT will produce greater reductions in symptoms compared to PC at post-treatment and follow-up (diverting attention away from threat).
- GC-MRT-exp will produce greater reductions in symptoms compared to PC at post-treatment follow-up (exposure via counter-conditioning by rewarding threat stimuli).
- Exploratory analysis will compare the reductions in symptoms of GC-MRT compared to GC-MRT-exp at post-treatment follow-up.
详细描述
GC-MRT is designed to shift participants' attention away from threat and toward neutral stimuli by introducing a contingency between viewing patterns and music pre-chosen by participants. Participants view matrices of faces with neutral and angry expressions. Viewing the neutral faces triggers music the participant previously requested, and viewing the angry faces turns the music off. The researchers will compare this condition (GC- MRT) to two additional conditions. In the "exposure" condition (GC-MRT-exp) the investigators will reverse the music contingency such that viewing the angry faces triggers the music while viewing the neutral faces turns the music off. In the placebo control (PC) condition, music plays continuously.
The goal of this study is to: (1) examine the efficacy of GC-MRT in PTSD; and (2) elucidate its underpinnings (i.e. attention control, reward processes, and exposure via counter-conditioning).
Attention control is the ability to shift attention deliberately based on goal-directed behavior. Accordingly, deficits in attention control can result in volatile shifts in attention leading to increase attention allocation to threat in the environment.
Reward functioning is the ability to seek out and enjoy stimuli of positive motivational valence, and is considered a crucial driving force of behavior, guiding the organism towards positive and rewarding experiences, ranging from food and gender to money, music, and positive social interactions.
Allocating visual attention to rewarding stimuli is considered a reward-related attentional feature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 18 and 80
- •Current DSM-5 diagnosis of PTSD
- •CAPS-V score greater than or equal to 25
- •Fluent in English and willing to give informed written consent and participate responsibly in the protocol.
- •Normal or corrected-to-normal vision
- •Mini Mental Status Exam score greater than or equal to 24.
排除标准
- •History of psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder
- •Current severe depression determined by a a) score greater than 25 on the Hamilton Rating Scale for Depression (HAM-D-17) and evaluation and b)clinical assessment
- •Suicidal ideation or behavior
- •Current or past diagnosis of obsessive compulsive disorder, bipolar disorder, epilepsy, or brain injury as determined by a Structured Clinical Interview for DSM-5 (SCID-5) interview
- •Current or past organic mental disorder, seizure disorder, epilepsy or brain injury as determined by a clinical evaluation
- •Diagnosis of probable Alzheimer's disease, Vascular Dementia, or Parkinson's Disease, as determined by a clinical evaluation and Mini Mental Status Exam (MMSE)
- •Current unstable or untreated medical illness
- •Drug or alcohol misuse- severe alcohol/cannabis disorder or any other substance use disorder except nicotine.
- •Recurrent psychotropic medication change or initiation within the last 3 months
- •Initiation of psychotherapy within the last 3 months
- •Current or past Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
- •Chronic pain that may affect sitting down and still for approximately 30 minutes
- •Current cognitive impairments as a result of a traumatic brain injury, as determined by a clinical evaluation
结局指标
主要结局
Changes in illness severity and improvement over time
时间窗: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Reduction in overall symptoms as measured by the Clinical Global Impressions scale (illness severity rated 0 to 7, with higher scores indicating more severe illness; improvement rated 0 to 7, with higher scores indicating less improvement.)
Change in depressive symptoms over time
时间窗: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-17; range 0-52) from pre- to post-treatment.
Change in anxiety symptoms over time
时间窗: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Change in symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A); range 0-56) from pre- to post-treatment.
Changes in suicidal ideation and depressive symptoms over time.
时间窗: each treatment session (weeks 2-10)
Assessment and monitoring of depressive symptoms and suicidal ideation, as measured through the Beck Depression Inventory-II (BDI-II). Scores range from 0 to 63, with higher scores reflecting more severe depression.
Change in PTSD symptoms over time
时间窗: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Reduction in symptoms as measured by the Clinician Administered PTSD Scale (Caps-5: ranging from 0-80 ). from pre- to post-treatment. Lower scores mean better outcome
Change in the severity of PTSD symptoms over time.
时间窗: Baseline, at 5 weeks, posttreatment at 10 weeks, follow up at 3 months from last session
Assesses for change in individual symptoms of PTSD and PTSD severity as measured by the Posttraumatic Stress Disorder Checklist (PCL-5). The severity of 20 PTSD symptoms is rated from 0 to 4, with higher numbers indicative of greater severity (score range of 0 to 80.)
Change in the ability to experience pleasure over time.
时间窗: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Change in anhedonia from pre- to post-treatment assessment will be assessed using the The Snaith-Hamilton Pleasure Scale (SHAPS: score range: 0-14, higher scores indicate less ability to experience pleasure).
Change in the ability to feel social pleasure over time
时间窗: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Change in anhedonia from pre- to post-treatment assessment will be assessed using the the Revised Social Anhedonia Scale (SHAPS: score range: 0-14, higher scores indicate less ability to experience pleasure).
Change in people's experiences of music as a reward over time.
时间窗: Baseline, at 5 weeks (midpoint), posttreatment at 10 weeks, follow up at 3 months from last session
Change in people's experiences of music as a reward and their relationship to music, as measured by the Barcelona Music Reward Questionnaire (BMRQ score range: 40-60, with higher scores indicate greater experiences of music as a reward)
次要结局
未报告次要终点
研究者
Yuval Y Neria
Principal Investigator
Research Foundation for Mental Hygiene, Inc.