Yoga/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

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Posttraumatic 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 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 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.

Group Type EXPERIMENTAL

Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Intervention Type BEHAVIORAL

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)

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

Group Type ACTIVE_COMPARATOR

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Intervention Type BEHAVIORAL

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Interventions

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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.

Intervention Type BEHAVIORAL

Trauma-focused Cognitive Behavioral Therapy (TF-CBT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed PTSD according to ICD-10
* PCL-5 Score of at least 33 points
* Undergoing outpatient CBT
* Physical and mental ability to perform Pranayama

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No