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Completed

NCT Number: NCT03748121

Yoga/Pranayama for Posttraumatic Stress Disorder

This study aims to investigate the effect of a pranayama focused yoga intervention on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard psychotherapy/ trauma-focused cognitive-behavioral therapy (TF-CBT). Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of standard TF-CBT unit, while the control group will get standard TF-CBT alone. It should further be investigated, whether pranayama can enhance the affective tolerance of patients with post-traumatic stress disorder towards the used exposure techniques of TF-CBT.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dietmar Mitzinger

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed PTSD according to ICD-10
  • PCL-5 Score of at least 33 points
  • Undergoing outpatient CBT
  • Physical and mental ability to perform Pranayama

Exclusion criteria

  • Severe comorbid mental or somatic disease that did not allow the patient to perform Pranayama
  • Pregnancy
  • Regular practice of Yoga or Pilates in the last 12 months

Treatment and study plan

Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Behavioral

The pranayama intervention is placed directly at the begin of the respective TF-CBT unit and will be repeated for 10 subsequent TF-CBT units. Pranayama contains the performance of Kapalabhati, Ujjayi, and/or Nadi Shodhana (for overall 1 minute) as well as following Kumbhaka (intentional respiratory reflex inhibition). Pranayama will be repeated 3 times before each TF-CBT unit.

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Behavioral

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Primary outcomes

  1. Intensity of posttraumtic symptoms

    Time frame: 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 outcomes

  1. Health-related quality of life

    Time frame: 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.

  2. Ability of social participation

    Time frame: week 10

    Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles and Activities Scale (PROMIS): The PROMIS-Social Participation Subscale is a standard 8-item scale ranging from 0 to 100 points with 100 points represent the highest possible ability to participate/function.

  3. Anxiety

    Time frame: 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.

  4. Depression

    Time frame: 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.

  5. Distress Tolerance

    Time frame: week 10

    Distress Tolerance Scale (DTS): The DTS is a standard 15-item scale ranging from 0 to 75 points. Higher scores represent higher distress tolerance.

  6. Emotion Regulation

    Time frame: week 10

    Emotion Regulation Scale (ERQ): The ERQ is a standard 10-item scale with 6 items are added to the Cognitive Reappraisal subscale ranging from 6 to 42 and 4 items are added to the Expressive Suppression subscale ranging from 4 to 28. Higher scores on the Cognitive Reappraisal subscale and lower ones on the Expressive Suppression subscale represent a better regulation of emotions.

  7. Body Awareness

    Time frame: week 10

    Scale of Body Connection (SBC): The SBC is a standard 20-items scale ranging from 0 to 80 that contains two subscales: Body Awareness and Body Dissociation. Higher scores on Body Awareness and lower scores on Body Dissociation represent a better body awareness.

  8. Breath Holding Duration

    Time frame: week 10

    Breath Holding Task (BHT): The BHT is standard test procedure for the measurement of ability of the suppression of the respiratory reflex. In PTSD patients, it is associated with distress tolerance.

  9. Acute Emotional Stress

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

    Emotional Stress Reaction Questionnaire (ESRQ): The ESRQ is standard 14-items scale ranging from -21 points (predominance of negative emotions) to +21 points (predominance of positive emotions). Patients received the ESRQ before and after each CBT unit.

  10. Adverse Events

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

    Number of patients with adverse events (and type of the adverse event)

Other outcomes

  1. Treatment Expectation

    Time frame: week 0

    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).

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial

Acronym: YOGAPTSD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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