A Frequency-Modulated Music Intervention to Enhance Cognitive Processing Therapy (CPT) for PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PTSD Symptom Severity (Self Rated)
研究概览
简要总结
The goal of this clinical trial is to learn if the addition of frequency filtered music (Safe and Sound Protocol) to daily cognitive processing therapy improves effectiveness for reducing PTSD symptoms. The main questions it aims to answer are:
- Does the addition of frequency filtered music reduce PTSD symptoms for patients receiving cognitive processing therapy for PTSD?
- Does the addition of frequency filtered music to cognitive processing therapy improve stress physiology (arousal)?
- Does improvement in physiological stress regulation help explain improvements in hyperarousal and PTSD symptoms? Researchers will compare the effects of a frequency filtered classical music playlist to an identical playlist without added filtering. Participants will be randomized to a music playlist.
Participants will:
- Receive 10 daily sessions of cognitive processing therapy
- Listen to 15 minutes of music before their therapy sessions (2.5 hours music listening total).
- Complete clinical interviews and questionnaires before, during, and up to 6 months after therapy.
- Have their physiological arousal monitored during listening and therapy sessions
- Wear a Fitbit device and complete smartphone surveys for 4 weeks
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Meets diagnostic criteria for a) PTSD or b) subthreshold PTSD with hyperarousal (i.e., meets diagnostic threshold for 3 of 4 symptoms, one of which is hyperarousal)
- •Ability to move between sitting to standing without assistance
- •Ability to attend two weeks of daily in-person therapy sessions at either the Ohio State University or at the Wright-Patterson Air Force Base (WPAFB) Medical Center
排除标准
- •Heart condition (such as cardiac arrhythmia) or pacemaker
- •An allergy that would prevent wearing adhesive for durations of 2 hours or less
- •Insufficient English fluency to fully engage in psychotherapy
- •Use of hearing aids
- •Current or prior tinnitus (persistent ringing or other noises in ears not caused by an external sound)
- •Severe traumatic brain injury
- •An ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome (e.g., undergoing disability evaluation, undergoing a medical board evaluation to be medically discharged from the military, pending negative administrative or legal actions).
- •Inability to complete the informed consent process due to the acute effects of a medical or psychiatric condition (e.g., intoxication, mania, psychosis)
研究组 & 干预措施
Unfiltered Music
Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of classical music with no frequency filtering before each therapy session (2.5 hours music listening total).
干预措施: Cognitive Processing Therapy for PTSD (Behavioral)
Frequency Filtered Music
Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of frequency filtered classical music before each therapy session (2.5 hours music listening total).
干预措施: Frequency Filtered Music (Other)
Frequency Filtered Music
Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of frequency filtered classical music before each therapy session (2.5 hours music listening total).
干预措施: Cognitive Processing Therapy for PTSD (Behavioral)
Unfiltered Music
Participants will receive 10 daily sessions of cognitive processing therapy (2 weeks total) and listen to 15 minutes of classical music with no frequency filtering before each therapy session (2.5 hours music listening total).
干预措施: Unfiltered Music (Other)
结局指标
主要结局
PTSD Symptom Severity (Self Rated)
时间窗: 1 month after treatment completion
PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.
PTSD Symptom Severity (Self Rated)
时间窗: 3 months after treatment completion
PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.
PTSD Symptom Severity (Self Rated)
时间窗: 6 months after treatment completion
PTSD symptom severity will be assessed using the PTSD Checklist for DSM 5 (PCL-5). The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.
次要结局
- PTSD Symptom Severity (Clinician Rated)(6 months after treatment completion)
- Hyperarousal Symptom Severity (Clinician Rated)(6 months after treatment completion)
- PTSD Diagnosis (Clinician Rated)(6 months after treatment completion)
- PTSD Symptom Severity (Clinician Rated)(1 month after treatment completion)
- PTSD Symptom Severity (Clinician Rated)(3 months after treatment completion)
- Hyperarousal Symptom Severity (Self Rated)(1 month after treatment completion)
- Hyperarousal Symptom Severity (Self Rated)(3 months after treatment completion)
- Hyperarousal Symptom Severity (Clinician Rated)(1 month after treatment completion)
- Hyperarousal Symptom Severity (Clinician Rated)(3 months after treatment completion)
- PTSD Diagnosis (Clinician Rated)(1 month after treatment completion)
- PTSD Diagnosis (Clinician Rated)(3 months after treatment completion)
- Change in parasympathetic activity during cognitive stress test(Change from 1 week before treatment start to 1 week after treatment completion)
- Change in sympathetic activity during cognitive stress test(Change from 1 week before treatment start to 1 week after treatment completion)
- Change in resting physiological arousal(Change from 1 week before treatment start to 1 week after treatment completion)
- Hyperarousal Symptom Severity (Self Rated)(6 months after treatment completion)
- Change in resting parasympathetic activity(Change from 1 week before treatment start to 1 week after treatment completion)
- Change in cardiac physiological arousal during cognitive stress test(Change from 1 week before treatment start to 1 week after treatment completion)
研究者
Jacek Kolacz
Research Assistant Professor
Ohio State University