Pranayama for Posttraumatic Stress Disorder

Universität Duisburg-Essen

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Post Traumatic Stress Disorder

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.

Trauma-focused standard psychotherapy (TF-SPT)BEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: week 10

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: week 10

Adverse Events

Number of patients with adverse events and types of the adverse events

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

Therapist Global Improvement

Data from ClinicalTrials.gov

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