Yoga/Pranayama for Posttraumatic Stress Disorder

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT); Behavioral: Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)

• Registration Number: NCT03748121
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)	Trauma-focused Cognitive Behavioral Therapy (TF-CBT)	Patients wait for 10 TF-CBT units and then are offered to learn pranayama.
Pranayama assisted Trauma-focused Cognitive Behavioral Therapy (TF-CBT)	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.

Primary Outcome Measures

Name	Time	Method
Intensity of posttraumtic symptoms	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

Name	Time	Method
Ability of social participation	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.
Body Awareness	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.
Depression	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.
Health-related quality of life	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.
Anxiety	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.
Acute Emotional Stress	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.
Adverse Events	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10	Number of patients with adverse events (and type of the adverse event)
Emotion Regulation	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.
Distress Tolerance	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.
Breath Holding Duration	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.

Trial Locations

Locations (1)

Dietmar Mitzinger; 🇩🇪 Neuss, NRW, Germany