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 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.

Official Title
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Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)
* Behavioral: Trauma-focused standard psychotherapy (TF-SPT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

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 standard psychotherapy (TF-SPT).<br>Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) The pranayama intervention is placed directly at the begin of the respective TF-SPT unit and will be repeated for 10 subsequent TF-SPT units. | Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)<br>* To prepare patients for the TF-SPT, they received 5-10 minutes of pranayama at the begin of each of the 10 TF-SPT units.<br>|
| Active Comparator: Trauma-focused standard psychotherapy (TF-SPT)<br>Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama. | Behavioral: Trauma-focused standard psychotherapy (TF-SPT)<br>* Patients wait for 10 TF-SPT units and then are offered to learn pranayama<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 | 
| 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 | 
| 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. | week 10 | 
| Adverse Events | Number of patients with adverse events and types of the adverse events | weeks 1,2,3,4,5,6,7,8,9,10 | 
| Therapist Global Improvement | Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7. | week 10 | 
| Patient Global Improvement | Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7. | week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Pranayama, Yoga, Complimentary Therapies, Somatic Symptom Disorder, SSD, PTSD, Safety, Effectiveness, Randomized Controlled Trail