Pranayama for Posttraumatic Stress Disorder (PRANAPTSD)

Universität Duisburg-Essen

Status: Withdrawn

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT); Behavioral: Trauma-focused standard psychotherapy (TF-SPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05645588

22-10859-BO

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)

Trauma-focused standard psychotherapy (TF-SPT)

Active Comparator group

Description:

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

Treatment:

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