search
Back to results

Pranayama for Posttraumatic Stress Disorder (PRANAPTSD)

Primary Purpose

Post Traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)
Trauma-focused standard psychotherapy (TF-SPT)
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Pranayama, Yoga, Complimentary Therapies, Somatic Symptom Disorder, SSD, PTSD, Safety, Effectiveness, Randomized Controlled Trail

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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: Substance dependence current use (ICD-10 F10.X, F11.X). Dementia (ICD-10 F00-F03) 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) 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) 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

    Trauma-focused standard psychotherapy (TF-SPT)

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Adverse Events
    Number of patients with adverse events and types of the adverse events
    Therapist Global Improvement
    Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7.
    Patient Global Improvement
    Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7.

    Full Information

    First Posted
    December 1, 2022
    Last Updated
    July 25, 2023
    Sponsor
    Universität Duisburg-Essen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05645588
    Brief Title
    Pranayama for Posttraumatic Stress Disorder
    Acronym
    PRANAPTSD
    Official Title
    Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2025 (Anticipated)
    Study Completion Date
    February 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universität Duisburg-Essen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder
    Keywords
    Posttraumatic Stress Disorder, Pranayama, Yoga, Complimentary Therapies, Somatic Symptom Disorder, SSD, PTSD, Safety, Effectiveness, Randomized Controlled Trail

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes 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 (outcome assessor) 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.
    Allocation
    Randomized
    Enrollment
    234 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pranayama assisted trauma-focused standard psychotherapy (TF-SPT).
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Trauma-focused standard psychotherapy (TF-SPT)
    Arm Type
    Active Comparator
    Arm Description
    Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Trauma-focused standard psychotherapy (TF-SPT)
    Intervention Description
    Patients wait for 10 TF-SPT units and then are offered to learn pranayama
    Primary Outcome Measure Information:
    Title
    Intensity of posttraumtic symptoms
    Description
    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 Outcome Measure Information:
    Title
    Health-related quality of life
    Description
    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
    Title
    Anxiety
    Description
    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
    Title
    Depression
    Description
    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
    Title
    Breath Holding Duration
    Description
    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
    Title
    Adverse Events
    Description
    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
    Title
    Therapist Global Improvement
    Description
    Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7.
    Time Frame
    week 10
    Title
    Patient Global Improvement
    Description
    Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7.
    Time Frame
    week 10
    Other Pre-specified Outcome Measures:
    Title
    Treatment Expectation
    Description
    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).
    Time Frame
    week 0
    Title
    Interoceptive Awareness
    Description
    Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-II): The MAIA-II is a 37-item questionnaire. It includes 8 subscales. Scores ranged between 0 and 5, where higher score indicate more awareness of bodily sensation. Percentiles can also be calculated, indicating how the score is associated to a normative sample.
    Time Frame
    weeks 0+10
    Title
    Social Readjustment after life events
    Description
    Social Readjustment Rating Scale (SRRS): The SRRS consists of 43 items. A sum score of 1-149 = low stress level; 150-299 = 30% probability of developing a stress-associated disease; 300 and more = 80% probability of developing a stress-associated disease.
    Time Frame
    weeks 0+10
    Title
    Compliance
    Description
    Diary (via App): daily pranayama practice, BHT time
    Time Frame
    weeks 0,1,2,3,4,5,6,7,8,9,10
    Title
    Medication
    Description
    A change in medication between weeks 0 and 10 is recorded.
    Time Frame
    weeks 0+10

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Substance dependence current use (ICD-10 F10.X, F11.X). Dementia (ICD-10 F00-F03) 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) 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) 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heidemarie Haller, PhD
    Phone
    +4920172377384
    Email
    heidemarie.haller@uk-essen.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dietmar Mitzinger, MSc
    Email
    mitzinger-yoga@t-online.de

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Pranayama for Posttraumatic Stress Disorder

    We'll reach out to this number within 24 hrs