Sanford Nidich1, Paul J Mills2, Maxwell Rainforth3, Pia Heppner2, Robert H Schneider3, Norman E Rosenthal4, John Salerno3, Carolyn Gaylord-King3, Thomas Rutledge2. 1. Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA. Electronic address: snidich@mum.edu. 2. VA San Diego Healthcare System, San Diego, CA, USA; Department of Family Medicine and Public Health, and Department of Psychiatry, University of California, San Diego, CA, USA. 3. Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA. 4. Department of Psychiatry, Georgetown University Medical School, Washington DC, USA.
Abstract
BACKGROUND: Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE). METHODS: We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to aTM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123. FINDINGS:Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score. INTERPRETATION: A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD. FUNDING: Department of Defense, US Army Medical Research.
RCT Entities:
BACKGROUND: Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE). METHODS: We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123. FINDINGS: Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score. INTERPRETATION: A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD. FUNDING: Department of Defense, US Army Medical Research.
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