Creative Art Teletherapy for Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
研究概览
简要总结
This project focuses on how the investigators can treat post-traumatic stress disorder (PTSD) with a Creative Art Teletherapy, Art-therapy Remote Treatment for Veterans Experiencing Trauma (ART-VET). Treatments for PTSD do not work well enough for many Veterans with PTSD. Many patients do not recover with current treatment methods. A core deficit in PTSD is an inability to feel safe in secure environments, and not to have flight, flight, or freeze behaviors. Unfortunately, many people have trouble with exposure-based psychotherapies and have trouble getting better or learning how to feel safer. Also, many rural Veterans are unable to attend treatment sessions in person.
The investigators plan to conduct a clinical trial of ART-VET, a promising 8 session (roughly weekly) teletherapy program, and the investigators will measure how well it works using many clinical and research measures before, during, and after participating in the therapy.
详细描述
The primary goal of this proposal is to evaluate a promising teletherapy for Veterans with posttraumatic stress disorder, ART-VET.
Problem: Current treatments for posttraumatic stress disorder (PTSD) face considerable challenges including high dropout rates and insufficient remission rates. First line pharmacotherapy using selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or psychotherapeutic methods such as prolonged exposure therapy result in remission rates between 20 and 50%, though this estimate is confounded by high dropout rates. Furthermore, gold-standard therapies such as trauma-focused cognitive behavior therapy (CBT), i.e. prolonged exposure and Cognitive Processing Therapy (CPT), face higher dropout rates in Veteran populations than civilian, and the proportion which receive an "adequate dose" of therapy is low due to poor compliance. These factors contribute to the chronicity of PTSD and concomitant declines in health and reduced quality of life for the estimated 23% of Veterans who served in recent conflicts, as well as their families and communities. Furthermore, access to care is restricted, particularly in the rural context. Approximately 4.4 million United States Veterans reside in rural communities, and 61% percent of rural Veterans are enrolled in the VA health care system, significantly higher than the 41% enrollment rate of urban Veterans. Rural health care challenges related to access to specialty care are intensified by combat-related injuries and illnesses such as PTSD. Thus, it is critical that the investigators develop alternative treatments while simultaneously improving our understanding of the mechanistic basis of PTSD.
Art-therapy Remote Treatment for Veterans Experiencing Trauma (ART-VET) shows promise as a tool to treat PTSD. ART-VET incorporates elements of other empirically supported psychotherapeutic methods, for example exposure therapy. While art therapy is already in use in the VA, there are fewer than 50 Art Therapists in the Veterans Health Administration (VHA) system, and expanded access is held back in part by the lack of robust clinical trial data. The proposed research builds on a successful pilot study whose results strongly supported further research on ART-VET.
Research Design and Methods: This research will determine if Creative Art Teletherapy reduces symptoms of PTSD as assessed by commonly used and validated clinical PTSD scales as well as a broad set of measures of domains frequently impacted by PTSD including sleep, depression, anxiety, and quality of life. Furthermore, the research will expand our understanding of the mechanistic basis of PTSD and the impact of Creative Art Teletherapy on those measures. The overall design is a wait-list control randomized clinical trial with partial cross-over, which allows the assessment of the impact of therapy for all participants as well as estimation of the symptom stability without treatment. The proposed research will also use functional magnetic resonance imaging measures to assess brain activity associated with PTSD symptoms during emotional image viewing and memory tasks. These will be combined to evaluate the relationships, patterns and clustering features of PTSD symptoms, comorbidities, psychosocial wellbeing, sleep quality, self-efficacy, functional brain measures, and quality of life measures as well as patterns of association with qualitative measures of art therapy and patient outcomes including imagery, self-report measures, narrative response themes and features, and clinical notes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •US Veterans with Post-traumatic stress disorder (PTSD)
- •Able to operate a pen & keyboard
- •Willing to participate in a Creative Art Teletherapy based intervention (including stable internet connection and compatible computing device)
- •English proficiency (study materials are only available in English; participants must be able to read and write in English)
- •Willing to provide informed consent. Consistent with ethical principles, all participants must be able to understand the nature of the experiment(s) they are volunteering to participate in, to understand their rights, risks, and potential benefits from their participation
- •Stable pharmacotherapy
排除标准
- •Major medical illness, in particular psychiatric, neurological or immunological (e.g., schizophrenia, organ failure, type-1 diabetes, significant auto-immune disease, etc.)
- •Major uncorrectable sensory deficit, such as blindness or hearing loss
- •Current drug or alcohol dependence or abuse
- •History of greater than moderate traumatic brain injury (TBI) or have experienced a TBI more recent than 12 months
- •Pregnancy
- •Unstable pharmacotherapy
- •Ongoing or planned psychotherapy. While ART-VET may be effective as an adjuvant to current standard of care psychotherapy, it would not be possible to disentangle the impacts of each in the present study. Potential participants with ongoing or planned psychotherapy will be offered the opportunity to initiate participation 3 months after completion if otherwise still eligible.
- •Contraindications to participation in intervention or magnetic resonance imaging (MRI) (Disqualification by indication of a contraindication to participation in intervention such as an allergy to materials (unlikely), presence of metal or MRI-unsafe material, claustrophobia or other preclusion to participation in MRI, or disqualification from participation not otherwise subsumed above)
研究组 & 干预措施
ART-VET
Immediate ART-VET
干预措施: Art-therapy Remote Treatment for Veterans Experiencing Trauma (Behavioral)
Waitlist control arm
Wait-list followed by ART-VET
干预措施: Art-therapy Remote Treatment for Veterans Experiencing Trauma (Behavioral)
结局指标
主要结局
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
时间窗: Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.
The CAPS-5 is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) and lifetime diagnosis of PTSD and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS-5 total PTSD symptom severity score is calculated by summing the severity ratings (range 0-4) of the 20 DSM-5 PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
次要结局
- Change from baseline in PTSD Checklist for DSM-5 (PCL-5) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Patient Health Questionnaire-9 (PHQ-9) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Van Dream Anxiety Scale (VDAS) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Positive and Negative Affect Schedule (PANAS) Short Form Positive and Negative Affect subscale scores(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Perceived Stress Scale (PSS) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) domain scores(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Change from baseline in Freiburg Mindfulness Inventory (FMI) total score(Baseline; waitlist pre-ART-VET assessment at approximately 8 weeks after baseline for participants assigned to waitlist; within 3 weeks after ART-VET completion; and approximately 3 months after ART-VET completion.)
- Working Alliance Inventory - Therapist Version (WAI-T) total score after ART-VET(Within 3 weeks after ART-VET completion)
- Working Alliance Inventory - Client Version (WAI-C) total score after ART-VET(Within 3 weeks after ART-VET completion)
- Change from pre-ART-VET to post-ART-VET in blood-oxygenation-level-dependent functional magnetic resonance imaging response to trauma-related and non-trauma-related visual stimuli(Pre-ART-VET MRI occurs at baseline for participants assigned to immediate ART-VET and at approximately 8 weeks after baseline for participants assigned to waitlist. Post-ART-VET MRI occurs within 3 weeks after ART-VET completion.)