Pranayama for Posttraumatic Stress Disorder

NCT05645588 | Withdrawn

• 1 other identifier: 22-10859-BO
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Pranayama; Yoga; Complimentary Therapies; Somatic Symptom Disorder; SSD; PTSD; Safety; Effectiveness; Randomized Controlled Trail

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Health-related quality of life

  week 10

• Anxiety

  week 10

• Depression

  week 10

• Breath Holding Duration

  week 10

• Adverse Events

  weeks 1,2,3,4,5,6,7,8,9,10

Other Outcomes (5)

• Treatment Expectation

  week 0

• Interoceptive Awareness

  weeks 0+10

• Social Readjustment after life events

  weeks 0+10

Study Arms (2)

Pranayama assisted trauma-focused standard psychotherapy (TF-SPT).

EXPERIMENTAL

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)

Trauma-focused standard psychotherapy (TF-SPT)

ACTIVE COMPARATOR

Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama.

Behavioral: Trauma-focused standard psychotherapy (TF-SPT)

Interventions

Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) BEHAVIORAL

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.

Pranayama assisted 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

Trauma-focused standard psychotherapy (TF-SPT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and Therapists (Care Provider) could not be blinded according to the nature of the intervention. However, therapists will be blinded to allocation concealment as they do not be aware of the patients' group assignment at baseline assessment until they open the opaque randomization envelope, which contains the patient randomization number and group assignment. The random sequence generation and the envelopes were prepared by the study coordinator who is not involved patient recruitment. Patients received post intervention questionnaires from a study assistant/nurse of the respective outpatient department (outcome assessor) who is also blinded to the patients' group assignment. After completing the questionnaires, the study assistant will sent them to study coordinator so that the therapist could not influence the patients' answers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE