An interventional study of Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in Posttraumatic Stress Disorder, sponsored by Universität Duisburg-Essen. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-06.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Treatment
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.
2,284 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 557 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Universität Duisburg-Essen is the lead sponsor of 85 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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)
Patients wait for 10 TF-CBT units and then are offered to learn pranayama.
Behavioral: 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.
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
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.
Time frame: week 10
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.
Time frame: week 10
Ability of social participation
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.
Time frame: week 10
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.
Time frame: week 10
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.
Time frame: week 10
Distress Tolerance
Distress Tolerance Scale (DTS): The DTS is a standard 15-item scale ranging from 0 to 75 points. Higher scores represent higher distress tolerance.
Time frame: week 10
Emotion Regulation
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.
Time frame: week 10
Body Awareness
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.
Time frame: week 10
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. In PTSD patients, it is associated with distress tolerance.
Time frame: week 10
Acute Emotional Stress
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.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Adverse Events
Number of patients with adverse events (and type of the adverse event)
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Treatment Expectation
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
Plan to share: Undecided — Upon reasonable request.
Ran from Feb 2018 to primary completion in Jul 2020, 29 months.
Of 911 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 29 months is below that.
Counting every sponsor, half of 937 studies reached it within 35 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →
Universität Duisburg-Essen