Yoga/Pranayama for Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)
* Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed PTSD according to ICD-10 PCL-5 Score of at least 33 points Undergoing outpatient CBT Physical and mental ability to perform Pranayama Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pranayama assisted Trauma-focused Cognitive Behavioral Therapy (TF-CBT)<br>To prepare patients for the TF-CBT, they received 5-10 minutes of pranayama at the begin of each of the 10 TF-CBT units. | Behavioral: Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)<br>* The pranayama intervention is placed directly at the begin of the respective TF-CBT unit and will be repeated for 10 subsequent TF-CBT units. Pranayama contains the performance of Kapalabhati, Ujjayi, and/or Nadi Shodhana (for overall 1 minute) as well as following Kumbhaka (intentional respiratory reflex inhibition). Pranayama will be repeated 3 times before each TF-CBT unit.<br>|
| Active Comparator: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)<br>Patients wait for 10 TF-CBT units and then are offered to learn pranayama. | Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)<br>* Trauma-focused Cognitive Behavioral Therapy (TF-CBT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of posttraumtic symptoms | 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. | week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Short Form 12 Health Survey (SF-12): The SF-12 is a standard 12-item scale with two sum scores (physical and mental quality of life) ranging from 0 to 100 points. | week 10 | 
| Ability of social participation | Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles and Activities Scale (PROMIS): The PROMIS-Social Participation Subscale is a standard 8-item scale ranging from 0 to 100 points with 100 points represent the highest possible ability to participate/function. | week 10 | 
| Anxiety | Beck Anxiety Inventory (BAI): The BAI is a standard 21-items scale ranging from 0 to 63 points with 0-7 points = minimal anxiety, 8-15 points = mild anxiety, 16-25 points = moderate anxiety, and 26-63 points = clinically relevant anxiety. | week 10 | 
| Depression | Beck Depression Inventory Revision (BDI-II): The BDI-II is a standard 21-items scale ranging from 0 to 63 points with 0-13 points =no/clinically not relevant depression/depression in remission, 14-19 points = mild depression, 20-28 points = moderate depression und 29-63 points = severe depression. | week 10 | 
| Distress Tolerance | Distress Tolerance Scale (DTS): The DTS is a standard 15-item scale ranging from 0 to 75 points. Higher scores represent higher distress tolerance. | week 10 | 
| Emotion Regulation | Emotion Regulation Scale (ERQ): The ERQ is a standard 10-item scale with 6 items are added to the Cognitive Reappraisal subscale ranging from 6 to 42 and 4 items are added to the Expressive Suppression subscale ranging from 4 to 28. Higher scores on the Cognitive Reappraisal subscale and lower ones on the Expressive Suppression subscale represent a better regulation of emotions. | week 10 | 
| Body Awareness | Scale of Body Connection (SBC): The SBC is a standard 20-items scale ranging from 0 to 80 that contains two subscales: Body Awareness and Body Dissociation. Higher scores on Body Awareness and lower scores on Body Dissociation represent a better body awareness. | week 10 | 
| Breath Holding Duration | Breath Holding Task (BHT): The BHT is standard test procedure for the measurement of ability of the suppression of the respiratory reflex. In PTSD patients, it is associated with distress tolerance. | week 10 | 
| Acute Emotional Stress | Emotional Stress Reaction Questionnaire (ESRQ): The ESRQ is standard 14-items scale ranging from -21 points (predominance of negative emotions) to +21 points (predominance of positive emotions). Patients received the ESRQ before and after each CBT unit. | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | 
| Adverse Events | Number of patients with adverse events (and type of the adverse event) | week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Cognitive-Behavioral Therapy, Complementary Therapies, Yoga, Pranayama, Effectiveness, Safety, Randomized Controlled Trial