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Yoga/Pranayama for Posttraumatic Stress Disorder (YOGAPTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748121
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Heidemarie Haller, Universität Duisburg-Essen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT) Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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 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.
Primary Purpose: Treatment
Official Title: Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pranayama assisted Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
To prepare patients for the TF-CBT, they received 5-10 minutes of pranayama at the begin of each of the 10 TF-CBT units.
Behavioral: Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)
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.

Active Comparator: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Patients wait for 10 TF-CBT units and then are offered to learn pranayama.
Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748121


Locations
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Germany
Dietmar Mitzinger
Neuss, NRW, Germany, 41460
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Study Director: Gustav Dobos, Prof. MD University of Duisburg-Essen
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Responsible Party: Heidemarie Haller, Postdoctoral Research Fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03748121    
Other Study ID Numbers: 17-7703-BO
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heidemarie Haller, Universität Duisburg-Essen:
Posttraumatic Stress Disorder
Cognitive-Behavioral Therapy
Complementary Therapies
Yoga
Pranayama
Effectiveness
Safety
Randomized Controlled Trial
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders