Posttraumatic Stress DisorderYOGAPTSDNCT03748121
Yoga/Pranayama for Posttraumatic Stress Disorder
A study testing Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in people with Posttraumatic Stress Disorder, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed PTSD according to ICD-10
- PCL-5 Score of at least 33 points
- Undergoing outpatient CBT
- Physical and mental ability to perform Pranayama
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial
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
- Being tested
- Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT), Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
- Keywords
- Posttraumatic Stress Disorder, Cognitive-Behavioral Therapy, Complementary Therapies, Yoga, Pranayama, Effectiveness, Safety, Randomized Controlled Trial
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)Behavioural
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)Behavioural
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 10
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start20 Feb 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study director, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748121
- Sponsor's protocol ID
- 17-7703-BO
- Acronym
- YOGAPTSD
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2018
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request.
Publications
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.
PubMed 37139325
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT03748121
- Acronym / sponsor ID
- YOGAPTSD / 17-7703-BO
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Cognitive-Behavioral Therapy, Complementary Therapies, Yoga, Pranayama, Effectiveness, Safety, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pranayama assisted Trauma-focused Cognitive Behavioral Therapy (TF-CBT) | Experimental | Behavioral: 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. |
| Trauma-focused Cognitive Behavioral Therapy (TF-CBT) | Active comparator | Behavioral: Trauma-focused Cognitive Behavioral Therapy (TF-CBT)Patients wait for 10 TF-CBT units and then are offered to learn pranayama. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed PTSD according to ICD-10
- PCL-5 Score of at least 33 points
- Undergoing outpatient CBT
- Physical and mental ability to perform Pranayama
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pranayama assisted 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. | Behavioural | Pranayama assisted Trauma-focused Cognitive Behavioral Therapy (TF-CBT) |
| Trauma-focused Cognitive Behavioral Therapy (TF-CBT)Trauma-focused Cognitive Behavioral Therapy (TF-CBT) | Behavioural | Trauma-focused Cognitive Behavioral Therapy (TF-CBT) |
Primary outcome
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.
10 secondary outcomes
Health-related quality of life
Time frame: week 10
Ability of social participation
Time frame: week 10
Anxiety
Time frame: week 10
Depression
Time frame: week 10
Distress Tolerance
Time frame: week 10
Emotion Regulation
Time frame: week 10
Body Awareness
Time frame: week 10
Breath Holding Duration
Time frame: week 10
Acute Emotional Stress
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Adverse Events
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 37139325Haller 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.
- Individual participant dataSharing planned: Undecided. Upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Dobos, Prof. MD study director
University of Duisburg-Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in people with Posttraumatic Stress Disorder, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of posttraumtic symptoms (time frame: week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03748121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.