Post Traumatic Stress DisorderPRANAPTSDNCT05645588
Pranayama for Posttraumatic Stress Disorder
A study testing Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) and Trauma-focused standard psychotherapy (TF-SPT) in people with Post Traumatic Stress Disorder, run by Universität Duisburg-Essen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) and Trauma-focused standard psychotherapy (TF-SPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2028
- 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 F43.1
- PCL-5 Score of at least 33 points
- Undergoing outpatient standard trauma-focused psychotherapy (Cognitive Behavioral Therapy, Psychodynamic Psychotherapy, or Systemic Psychotherapy)
Who cannot join
- 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)
Show all 9Show fewer
- Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
- Pregnancy / breastfeeding
- Regular pranayama practice in the last 12 months
About this study
Official title: Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Pranayama assisted trauma-focused standard psychotherapy (TF-SPT), Trauma-focused standard psychotherapy (TF-SPT)
- Keywords
- Posttraumatic Stress Disorder, Pranayama, Yoga, Complimentary Therapies, Somatic Symptom Disorder, SSD, PTSD, Safety, Effectiveness, Randomized Controlled Trail
- 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 standard psychotherapy (TF-SPT)Behavioural
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.
Trauma-focused standard psychotherapy (TF-SPT)Behavioural
Patients wait for 10 TF-SPT units and then are offered to learn pranayama
| Study group | Role | What they receive |
|---|---|---|
| Pranayama assisted trauma-focused standard psychotherapy (TF-SPT). | Experimental | 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. Receives: Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) |
| Trauma-focused standard psychotherapy (TF-SPT) | Active comparator | Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama. Receives: Behavioral: Trauma-focused standard psychotherapy (TF-SPT) |
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 (7)
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
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
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.
Measured: week 10
Adverse Events
Number of patients with adverse events and types of the adverse events
Measured: weeks 1,2,3,4,5,6,7,8,9,10
Therapist Global Improvement
Clinician Global Impression of Improvement (CGI-I) rated by the therapist on 1 item ranging from 1 to 7.
Measured: week 10
Patient Global Improvement
Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7.
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Why it stopped: no sufficient funding, employee have left the company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic 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
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645588
- Sponsor's protocol ID
- 22-10859-BO
- Acronym
- PRANAPTSD
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pranayama for Outpatients With Posttraumatic Stress Disorder: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05645588
- Acronym / sponsor ID
- PRANAPTSD / 22-10859-BO
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Pranayama, Yoga, Complimentary Therapies, Somatic Symptom Disorder, SSD, PTSD, Safety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no sufficient funding, employee have left the company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Dec 2022 (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 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.
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 standard psychotherapy (TF-SPT). | Experimental | Behavioral: Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)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. |
| Trauma-focused standard psychotherapy (TF-SPT) | Active comparator | Behavioral: Trauma-focused standard psychotherapy (TF-SPT)Behavioral: Patients wait for 10 TF-SPT 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 (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama:
- Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
- Pregnancy / breastfeeding
- Regular pranayama practice 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 standard psychotherapy (TF-SPT)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. | Behavioural | Pranayama assisted trauma-focused standard psychotherapy (TF-SPT). |
| Trauma-focused standard psychotherapy (TF-SPT)Patients wait for 10 TF-SPT units and then are offered to learn pranayama | Behavioural | Trauma-focused standard psychotherapy (TF-SPT) |
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.
7 secondary outcomes
Health-related quality of life
Time frame: week 10
Anxiety
Time frame: week 10
Depression
Time frame: week 10
Breath Holding Duration
Time frame: week 10
Adverse Events
Time frame: weeks 1,2,3,4,5,6,7,8,9,10
Therapist Global Improvement
Time frame: week 10
Patient Global Improvement
Time frame: week 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) and Trauma-focused standard psychotherapy (TF-SPT) in people with Post Traumatic Stress Disorder, run by Universität Duisburg-Essen.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
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 30 Mar 2025.