Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 234
- 主要终点
- Intensity of posttraumtic symptoms
研究概览
简要总结
This study aims to investigate the effect of pranayama (yoga-breathing techniques) on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard, out-patient, trauma-focused psychotherapy. Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of psychotherapy unit, while the control group will receive standard, trauma-focused psychotherapy alone.
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 (Investigator, Outcomes Assessor)
盲法说明
Participants and Therapists (Care Provider) could not be blinded according to the nature of the intervention. However, therapists will be blinded to allocation concealment as they do not be aware of the patients' group assignment at baseline assessment until they open the opaque randomization envelope, which contains the patient randomization number and group assignment. The random sequence generation and the envelopes were prepared by the study coordinator who is not involved patient recruitment. Patients received post intervention questionnaires from a study assistant/nurse of the respective outpatient department (outcome assessor) who is also blinded to the patients' group assignment. After completing the questionnaires, the study assistant will sent them to study coordinator so that the therapist could not influence the patients' answers.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed PTSD according to ICD-10 F43.1
- •PCL-5 Score of at least 33 points
- •Undergoing outpatient standard trauma-focused psychotherapy (Cognitive Behavioral Therapy, Psychodynamic Psychotherapy, or Systemic Psychotherapy)
排除标准
- •Pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama:
- •Substance dependence current use (ICD-10 F10.X, F11.X).
- •Dementia (ICD-10 F00-F03)
- •Somatoform Disorder (ICD F45.X) of moderate or severe degree according to DSM-5 300.82: ≥ 2 reactions (cognitive, emotional, or behavioral) to somatic symptoms (≥ 2 criterion-B)
- •Severe cardiovascular disease: presence of cardiac or vascular implants or grafts, e.g., pacemaker (ICD-10 Z95.X), condition after organ or tissue transplantation (ICD-10 Z94.X)
- •Acute adverse events occurring during pranayama at baseline (including neck pain, subjective sensation of pressure in the lungs, anxiety / panic)
- •Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
- •Pregnancy / breastfeeding
- •Regular pranayama practice in the last 12 months
结局指标
主要结局
Intensity of posttraumtic symptoms
时间窗: week 10
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): The PCL-5 is a standard 20-item scale with a sum score ranging from 0 to 80 points. The cut-off point for clinically relevant symptom severity is 33 points.
次要结局
- Therapist Global Improvement(week 10)
- Patient Global Improvement(week 10)
- Health-related quality of life(week 10)
- Anxiety(week 10)
- Depression(week 10)
- Breath Holding Duration(week 10)
- Adverse Events(weeks 1,2,3,4,5,6,7,8,9,10)
研究者
Heidemarie Haller
Director of Research
Universität Duisburg-Essen