Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- The Primary Outcome Measure is analysis of functional neuroimaging metrics
研究概览
简要总结
Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend eleven sessions over a period of six to eight months. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The following eight sessions will be one-hour art therapy sessions with a certified art therapist. The tenth session will consist of the same self-assessment questionnaires and another MRI scan. The final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.
详细描述
Art Therapy is used across the Military Health System (MHS) as part of interdisciplinary treatment programs with great success, but there is limited research on how this art therapy works. Therefore, the purpose of this research is to learn about the effects of art therapy on emotional expression and regulation in service members as well as the impact of art therapy on brain systems. If a participant chooses to be in this study he or she will attend eleven sessions over a period of six to eight months. The first session and tenth sessions of this research study will include interviews and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and a magnetic resonance imaging (MRI) scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. These sessions will be about 2.5 to 3 hours. The sessions two through nine will include a one-hour art therapy sessions with a certified art therapist. The art therapy sessions are also considered research interventions. The eleventh and final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.
There is the risk that participants may experience increased psychological or emotional distress or frustration when discussing traumatic events during either the art research intervention sessions or during the questionnaires or interviews. Participants may experience a reduction in symptoms associated with posttraumatic stress (PTS), mild traumatic brain injury (mTBI), and/or other psychological heath disorders through the art therapy process. However, there is no guarantee that participants will benefit from being in this research. As an alternative to this research, participants can talk to your physician about art therapy or other therapeutic options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DEERS Eligible
- •Active Duty or Veteran separated within the past 10 years
- •Significant posttraumatic stress symptoms (score of >/=31 on the PCL-5)
排除标准
- •History of moderate, severe, or penetrating brain injury
- •History of psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
- •History of multiple sclerosis, Huntington's disease, or Alzheimer's disease
- •History of stroke or myocardial infarction
- •History of brain tumor
- •History of seizures
- •Contradictions for MRI (for example, participants will be excluded for pregnancy, metal implants or suspected shrapnel, aneurysm/intracranial clips, cardiac pacemakers or implanted programmable devices or pumps)
- •Unable to provide informed consent
- •History of previous exposure to art therapy
- •Active substance use disorder
研究组 & 干预措施
Art Therapy Arm
8 weeks of individual art therapy
干预措施: Art Therapy (Behavioral)
结局指标
主要结局
The Primary Outcome Measure is analysis of functional neuroimaging metrics
时间窗: Through study completion, an average of 14 weeks
The primary outcome measure is the analysis of resting state and task based functional MRI data which include but functional connectivity measures between brain regions at rest and during the task as well as functional activation patterns during the task. MRI and a series of task based fMRI sequences.
The Primary Outcome Measure is analysis of functional neuroimaging metrics
时间窗: Baseline
The primary outcome measure is the analysis of resting state and task based functional MRI data which include but functional connectivity measures between brain regions at rest and during the task as well as functional activation patterns during the task. MRI and a series of task based fMRI sequences.
次要结局
- Toronto Alexithymia Scale (TAS-20)(Through study completion, an average of 14 weeks)
- PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)(Study completion, an average of six to eight months)
- Neurobehavioral Symptoms Inventory (NSI)(Study completion, an average of six to eight months)
- General Self Efficacy Scale (GSES)(Study completion, an average of six to eight months)
- Generalized Anxiety Disorder-7 (GAD-7)(Study completion, an average of six to eight months)
- Self-Regulation Questionnaire (SRQ)(Study completion, an average of six to eight months)
- Perceived Stress Scale (PSS)(Study completion, an average of six to eight months)
- Revised Helping Alliance Questionnaire (HAQ-II)(Through study completion, an average of 14 weeks)
- Moral Injury Events Scale (MIES)(Through study completion, an average of 14 weeks)
- Toronto Alexithymia Scale (TAS-20)(Baseline)
- PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)(Baseline)
- PTSD Checklist for the Diagnostics and Statistics Manual Five (DSM-V) (PCL-5)(Through study completion, an average of 14 weeks)
- Neurobehavioral Symptoms Inventory (NSI)(Baseline)
- Neurobehavioral Symptoms Inventory (NSI)(Through study completion, an average of 14 weeks)
- General Self Efficacy Scale (GSES)(Baseline)
- General Self Efficacy Scale (GSES)(Through study completion, an average of 14 weeks)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline)
- Generalized Anxiety Disorder-7 (GAD-7)(Through study completion, an average of 14 weeks)
- Self-Regulation Questionnaire (SRQ)(Baseline)
- Self-Regulation Questionnaire (SRQ)(Through study completion, an average of 14 weeks)
- Perceived Stress Scale (PSS)(Baseline)
- Perceived Stress Scale (PSS)(Through study completion, an average of 14 weeks)
- Moral Injury Events Scale (MIES)(Baseline)