Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans
Objective Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.Setting Outpatient Veterans Affairs healthcare centre.Part...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/8/e056609.full |
| _version_ | 1818495855258238976 |
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| author | Danielle C Mathersul Julia S Tang R Jay Schulz-Heik Emma M Seppälä Peter J Bayley Beatriz Hernández Tim Avery Melinda Wong Jamie M Zeitzer Craig S Rosen Adam S Burn Laura C Lazzeroni |
| author_facet | Danielle C Mathersul Julia S Tang R Jay Schulz-Heik Emma M Seppälä Peter J Bayley Beatriz Hernández Tim Avery Melinda Wong Jamie M Zeitzer Craig S Rosen Adam S Burn Laura C Lazzeroni |
| author_sort | Danielle C Mathersul |
| collection | DOAJ |
| description | Objective Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.Setting Outpatient Veterans Affairs healthcare centre.Participants 85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study.Interventions SKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks.Measures The primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS).Results Mean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, −5.6, d=0.41, n=41: CPT, −6.8, d=0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (−1.2, 95% CI −5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT–SKY: −2.1, 95% CI −6.9 to 2.8) and 1-year (CPT–SKY: −1.8, 95% CI −6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54).Conclusions SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD.Trial registration number NCT02366403. |
| first_indexed | 2024-12-10T18:26:15Z |
| format | Article |
| id | doaj.art-f014dde3159a42ecb3794a3e3ed343e2 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-10T18:26:15Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-f014dde3159a42ecb3794a3e3ed343e22022-12-22T01:38:04ZengBMJ Publishing GroupBMJ Open2044-60552022-08-0112810.1136/bmjopen-2021-056609Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veteransDanielle C Mathersul0Julia S Tang1R Jay Schulz-Heik2Emma M Seppälä3Peter J Bayley4Beatriz Hernández5Tim Avery6Melinda Wong7Jamie M Zeitzer8Craig S Rosen9Adam S Burn10Laura C Lazzeroni111 War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA1 War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA1 War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA3 Center for Compassion and Altruism Research and Education, Stanford University School of Medicine, Stanford, California, USA1 War Related Illness and Injury Study Center, Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USADepartment of Anaesthesia, Son Llàtzer University Hospital, Palma de Mallorca, SpainWar Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USAWar Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USADepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USADepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USAWar Related Illness and Injury Study Center, VA Palo Alto Health Care System, Palo Alto, California, USADepartment of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USAObjective Test whether Sudarshan Kriya Yoga (SKY) was non-inferior to cognitive processing therapy (CPT) for treating symptoms of post-traumatic stress disorder (PTSD) among veterans via a parallel randomised controlled non-inferiority trial.Setting Outpatient Veterans Affairs healthcare centre.Participants 85 veterans (75 men, 61% white, mean age 56.9) with symptoms of PTSD participated between October 2015 and March 2020: 59 participants completed the study.Interventions SKY emphasises breathing routines and was delivered in group format in a 15-hour workshop followed by two 1-hour sessions per week for 5 weeks. CPT is an individual psychotherapy which emphasises shifting cognitive appraisals and was delivered in two 1-hour sessions per week for 6 weeks.Measures The primary outcome measure was the PTSD Checklist-Civilian Version (PCL-C). The secondary measures were the Beck Depression Inventory-II (BDI-II) and Positive and Negative Affect Scale (PANAS).Results Mean PCL-C at baseline was 56.5 (±12.6). Intent-to-treat analyses showed that PCL-C scores were reduced at 6 weeks (end of treatment) relative to baseline (SKY, −5.6, d=0.41, n=41: CPT, −6.8, d=0.58, n=44). The between-treatment difference in change scores was within the non-inferiority margin of 10 points (−1.2, 95% CI −5.7 to 3.3), suggesting SKY was not inferior to CPT. SKY was also non-inferior at 1-month (CPT–SKY: −2.1, 95% CI −6.9 to 2.8) and 1-year (CPT–SKY: −1.8, 95% CI −6.6 to 2.9) assessments. SKY was also non-inferior to CPT on the BDI-II and PANAS at end of treatment and 1 month, but SKY was inferior to CPT on both BDI-II and PANAS at 1 year. Dropout rates were similar (SKY, 27%, CPT, 34%: OR=1.36, 95% CI 0.51 to 3.62, p=0.54).Conclusions SKY may be non-inferior to CPT for treating symptoms of PTSD and merits further consideration as a treatment for PTSD.Trial registration number NCT02366403.https://bmjopen.bmj.com/content/12/8/e056609.full |
| spellingShingle | Danielle C Mathersul Julia S Tang R Jay Schulz-Heik Emma M Seppälä Peter J Bayley Beatriz Hernández Tim Avery Melinda Wong Jamie M Zeitzer Craig S Rosen Adam S Burn Laura C Lazzeroni Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans BMJ Open |
| title | Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans |
| title_full | Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans |
| title_fullStr | Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans |
| title_full_unstemmed | Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans |
| title_short | Randomised clinical non-inferiority trial of breathing-based meditation and cognitive processing therapy for symptoms of post-traumatic stress disorder in military veterans |
| title_sort | randomised clinical non inferiority trial of breathing based meditation and cognitive processing therapy for symptoms of post traumatic stress disorder in military veterans |
| url | https://bmjopen.bmj.com/content/12/8/e056609.full |
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