Pranayama for Posttraumatic Stress Disorder (PRANAPTSD)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT); Behavioral: Trauma-focused standard psychotherapy (TF-SPT)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT).; 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); 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.
Active Comparator: Trauma-focused standard psychotherapy (TF-SPT); Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama.	Behavioral: Trauma-focused standard psychotherapy (TF-SPT); Patients wait for 10 TF-SPT units and then are offered to learn pranayama

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Compliance	Diary (via App): daily pranayama practice, BHT time	weeks 0,1,2,3,4,5,6,7,8,9,10
Medication	A change in medication between weeks 0 and 10 is recorded.	weeks 0+10
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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Safety; Yoga; Posttraumatic Stress Disorder; Pranayama; Effectiveness; Complimentary Therapies; Somatic Symptom Disorder; SSD; Randomized Controlled Trail
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 22-10859-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No