Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Intensity of posttraumtic symptoms
研究概览
简要总结
This study aims to investigate the effect of a pranayama focused yoga intervention on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard psychotherapy/ trauma-focused cognitive-behavioral therapy (TF-CBT). Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of standard TF-CBT unit, while the control group will get standard TF-CBT alone. It should further be investigated, whether pranayama can enhance the affective tolerance of patients with post-traumatic stress disorder towards the used exposure techniques of TF-CBT.
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 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
- •PCL-5 Score of at least 33 points
- •Undergoing outpatient CBT
- •Physical and mental ability to perform Pranayama
排除标准
- •Severe comorbid mental or somatic disease that did not allow the patient to perform Pranayama
- •Pregnancy
- •Regular practice of Yoga or Pilates 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
- Ability of social participation(week 10)
- Body Awareness(week 10)
- Depression(week 10)
- Health-related quality of life(week 10)
- Anxiety(week 10)
- Acute Emotional Stress(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)
- Adverse Events(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)
- Emotion Regulation(week 10)
- Distress Tolerance(week 10)
- Breath Holding Duration(week 10)
研究者
Heidemarie Haller
Postdoctoral Research Fellow
Universität Duisburg-Essen