Yoga/Pranayama for Posttraumatic Stress Disorder

NCT03748121 | Completed

• 1 other identifier: 17-7703-BO
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Cognitive-Behavioral Therapy; Complementary Therapies; Yoga; Pranayama; Effectiveness; Safety; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  week 10

Secondary Outcomes (10)

• Health-related quality of life

  week 10

• Ability of social participation

  week 10

• Anxiety

  week 10

• Depression

  week 10

• Distress Tolerance

  week 10

Other Outcomes (1)

• Treatment Expectation

  week 0

Study Arms (2)

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

EXPERIMENTAL

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)

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

ACTIVE COMPARATOR

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

Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Interventions

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.

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

Trauma-focused Cognitive Behavioral Therapy (TF-CBT) BEHAVIORAL

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Dietmar Mitzinger

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Related Publications (1)

• Haller H, Mitzinger D, Cramer H. The integration of yoga breathing techniques in cognitive behavioral therapy for post-traumatic stress disorder: A pragmatic randomized controlled trial. Front Psychiatry. 2023 Apr 17;14:1101046. doi: 10.3389/fpsyt.2023.1101046. eCollection 2023.

  PMID: 37139325 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gustav Dobos, Prof. MD

  University of Duisburg-Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: February 20, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

DE (1)