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Yoga/Pranayama for Posttraumatic Stress Disorder (YOGAPTSD)

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ClinicalTrials.gov Identifier: NCT03748121
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 21, 2019
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 posttraumatic symptom severity in patients with posttraumatic stress disorder undergoing standard psychotherapy/cognitive-behavioral therapy (CBT). Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly before each of standard CBT units, while the control group will get standard CBT alone. It should further be investigated, whether Pranayama can enhance the affective tolerance of patients with posttraumatic stress disorder towards the used exposure techniques of CBT.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Pranayama Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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: Yoga/Pranayama as an add-on to Standard Psychotherapy in Patients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pranayama + Cognitive Behavioral Therapy (CBT)
To prepare patients for the CBT, they received 5-10 minutes of pranayama befor each of the 10 CBT units.
Behavioral: Pranayama
The pranayama intervention is placed directly before the respective CBT unit and will be repeated for 10 subsequent CBTS units. Pranayama containes 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 CBT unit.

Behavioral: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT)

Active Comparator: Cognitive Behavioral Therapy (CBT) + Pranayama
Patients wait for 10 CBT units and then received the pranayama intervention.
Behavioral: Pranayama
The pranayama intervention is placed directly before the respective CBT unit and will be repeated for 10 subsequent CBTS units. Pranayama containes 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 CBT unit.

Behavioral: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (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


Contacts
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Contact: Heidemarie Haller, PhD +4920117425044 h.haller@kem-med.com
Contact: Holger Cramer, PhD +4920117425015 h.cramer@kem-med.com

Locations
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Germany
Dietmar Mitzinger Recruiting
Neuss, NRW, Germany, 41460
Contact: Dietmar Mitzinger, MSc.    +492131277520    mitzinger-yoga@t-online.de   
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     History of Changes
Other Study ID Numbers: 17-7703-BO
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
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