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no sufficient funding, employee have left the company
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Trauma-focused standard psychotherapy (TF-SPT) | Active Comparator | Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pranayama assisted trauma-focused standard psychotherapy (TF-SPT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 10 |
| Anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | week 0 |
| Interoceptive Awareness |
Inclusion Criteria:
Exclusion Criteria:
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
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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 (outcome assessor) 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.
| Trauma-focused standard psychotherapy (TF-SPT) | Behavioral | Patients wait for 10 TF-SPT units and then are offered to learn pranayama |
|
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.
| 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. | 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. | week 10 |
| Adverse Events | Number of patients with adverse events and types of the adverse events | 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. | week 10 |
| Patient Global Improvement | Patient Global Impression of Improvement (PGI-I) rated by the patient on 1 item ranging from 1 to 7. | week 10 |
Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-II): The MAIA-II is a 37-item questionnaire. It includes 8 subscales. Scores ranged between 0 and 5, where higher score indicate more awareness of bodily sensation. Percentiles can also be calculated, indicating how the score is associated to a normative sample.
| weeks 0+10 |
| Social Readjustment after life events | Social Readjustment Rating Scale (SRRS): The SRRS consists of 43 items. A sum score of 1-149 = low stress level; 150-299 = 30% probability of developing a stress-associated disease; 300 and more = 80% probability of developing a stress-associated disease. | weeks 0+10 |
| Compliance | Diary (via App): daily pranayama practice, BHT time | weeks 0,1,2,3,4,5,6,7,8,9,10 |
| Medication | A change in medication between weeks 0 and 10 is recorded. | weeks 0+10 |