Pranayama for Posttraumatic Stress Disorder

Not Applicable

Withdrawn

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Trauma-focused standard psychotherapy (TF-SPT); Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)

• Registration Number: NCT05645588
• Lead Sponsor: Universität Duisburg-Essen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2025-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2027-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 234

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intensity of posttraumtic symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Therapist Global Improvement	week 10	Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7.
Patient Global Improvement	week 10	Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7.
Health-related quality of life	week 10	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.
Anxiety	week 10	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.
Depression	week 10	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.
Breath Holding Duration	week 10	Breath Holding Task (BHT): The BHT is standard test procedure for the measurement of ability of the suppression of the respiratory reflex.
Adverse Events	weeks 1,2,3,4,5,6,7,8,9,10	Number of patients with adverse events and types of the adverse events