Pranayama for Posttraumatic Stress Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-02-01

Brief Summary

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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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Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Pranayama assisted trauma-focused standard psychotherapy (TF-SPT)

Intervention Type 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.

Trauma-focused standard psychotherapy (TF-SPT)

Behavioral: Patients wait for 10 TF-SPT units and then are offered to learn pranayama.

Group Type ACTIVE_COMPARATOR

Trauma-focused standard psychotherapy (TF-SPT)

Intervention Type BEHAVIORAL

Patients wait for 10 TF-SPT units and then are offered to learn pranayama

Interventions

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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.

Intervention Type BEHAVIORAL

Trauma-focused standard psychotherapy (TF-SPT)

Patients wait for 10 TF-SPT units and then are offered to learn pranayama

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Pre-existing mental or somatic conditions that are unlikely to result in correct or safe performance of pranayama:

1. Substance dependence current use (ICD-10 F10.X, F11.X).
2. Dementia (ICD-10 F00-F03)
3. 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)
4. 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)
5. Acute adverse events occurring during pranayama at baseline (including neck pain, subjective sensation of pressure in the lungs, anxiety / panic)
* Cancer diagnosis in the past 5 years (ICD-10 C00-C97, D37-48)
* Pregnancy / breastfeeding
* Regular pranayama practice in the last 12 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No