Pranayama for Posttraumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

— PRANAPTSD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05645588
• Other study ID #: 22-10859-BO
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Universität Duisburg-Essen
• Contact: Heidemarie Haller, PhD
• Phone: +4920172377384
• Email: heidemarie.haller[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

1. Substance dependence current use (ICD-10 F10.X, F11.X).

2. Dementia (ICD-10 F00-F03)

3. 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)

4. 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)

5. 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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)
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.
• Trauma-focused standard psychotherapy (TF-SPT)
Patients wait for 10 TF-SPT units and then are offered to learn pranayama

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectation	Treatment Credibility Scale (TCS): The TCS is a standard NRS scale ranging from 0 points (lowest expectation of treatment effectiveness) to 10 points (highest expectation of treatment effectiveness).	week 0
Other	Interoceptive Awareness	Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-II): The MAIA-II is a 37-item questionnaire. It includes 8 subscales. Scores ranged between 0 and 5, where higher score indicate more awareness of bodily sensation. Percentiles can also be calculated, indicating how the score is associated to a normative sample.	weeks 0+10
Other	Social Readjustment after life events	Social Readjustment Rating Scale (SRRS): The SRRS consists of 43 items. A sum score of 1-149 = low stress level; 150-299 = 30% probability of developing a stress-associated disease; 300 and more = 80% probability of developing a stress-associated disease.	weeks 0+10
Other	Compliance	Diary (via App): daily pranayama practice, BHT time	weeks 0,1,2,3,4,5,6,7,8,9,10
Other	Medication	A change in medication between weeks 0 and 10 is recorded.	weeks 0+10
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Therapist Global Improvement	Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7.	week 10
Secondary	Patient Global Improvement	Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7.	week 10