Evaluating the Efficacy of the MentalGym™ and NeuroBrave™ Guided Wearable-Assisted Physiology Regulation Training for PTSD: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in PTSD Symptom Severity (PCL-5 Total Score)
研究概览
简要总结
This randomized controlled trial (RCT) will evaluate the effectiveness of a digital biofeedback-based intervention ("Mental Gym®") designed to reduce Posttraumatic Stress Disorder (PTSD) symptoms and improve mental health. The intervention combines daily HRV biofeedback exercises using a wearable device (Garmin watch), a dedicated mobile application, and weekly group guidance sessions. A delayed-intervention control group design will be used. To account for expected attrition and ensure a final sample of 60 participants, approximately 80 subjects will be recruited. Physiological and self-report data will be collected pre- and post-intervention, weekly during the intervention, and at follow-ups (3 months post-intervention). The study population consists of combat veterans diagnosed with PTSD.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
盲法说明
This is an open-label behavioural/digital intervention. Due to the nature of the intervention, participants and study staff are not blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- Sex: All
- Age: 18 Years and older.
- Diagnosis: Clinical diagnosis of Posttraumatic Stress Disorder (PTSD) with mild to moderate-severe symptom intensity.
- Symptom Severity: A PCL-5 total score of up to 60 at screening.
- Traumatic Event: PTSD diagnosis based on a traumatic event that occurred in the year 2000 or later.
- Service Eligibility: Eligibility for Ministry of Defense (MOD) rehabilitation services.
- Technical Proficiency: Ability to use a smartphone and a wearable device.
排除标准
- High Symptom Severity: PTSD symptom severity exceeding the moderate-severe range (PCL-5 score > 60) or requiring more intensive clinical intervention.
- Psychiatric Stability: Acute psychiatric instability, including active suicidal ideation or psychosis.
- Medication: Current use of Olanzapine (Zyprexa) or Quetiapine (Seroquel).
- Sleep Disturbances: Severe sleep impairment (score > 7 on the The Insomnia Severity Index).
- Functional Impairment: Severe impairment in concentration or cognitive processing that precludes the use of digital biofeedback tools.
研究组 & 干预措施
Mental Gym® Immediate Intervention
干预措施: Mental Gym® Biofeedback System (Behavioral)
Delayed Intervention (Waitlist Control plus Garmin Watch)
Participants in this arm will initially serve as a no-intervention control group for a period of 8 weeks, during which they will continue with their Treatment as Usual (TAU). Following this 8-week period, they will receive the full 'Mental Gym®' intervention, identical to the experimental group, including the mobile application, and weekly sessions.
结局指标
主要结局
Change in PTSD Symptom Severity (PCL-5 Total Score)
时间窗: Baseline (Week 0) and Post-Intervention (Week 8).
The primary outcome is the change in the total score of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure; items are rated on a 0-4 point scale. Total score ranges from 0 to 80, where higher scores indicate greater symptom severity. PCL scores are expected to reduce in the intervention but not in the control groups.
次要结局
- Long term retention of Treatment Effects in the Intervention Group(Baseline (Week 0), Post-Intervention (Week 8), 1.5-month Follow-up (Week 14), and 3-month Follow-up (Week 20))
- Change in Autonomic Regulation (Resting HRV)(Baseline (Week 0) and Post-Intervention (Week 8))
- Change in Generalized Anxiety Symptoms (GAD-7)(Baseline (Week 0) and Post-Intervention (Week 8))
- Change in Depressive Symptoms (PHQ-9)(Baseline (Week 0), Post-Intervention (Week 8))
- Change in Psychological Resilience (CD-RISC-10)(Baseline (Week 0), Post-Intervention (Week 8))
- Change in Sleep Quality (ISI)(Baseline (Week 0), Post-Intervention (Week 8))
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07462312
- 其他研究编号
- P_2025176
日期
- 首次提交
- (6个月前)
- 首次发布
- (6个月前)
- 主要完成日期
- (16天前)
- 研究完成日期
- (16天前)
- 最近核实
- (5个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否