Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study

The overarching aim of this proposal is to research whether meditation-based treatments are effective in decreasing posttraumatic stress disorder (PSTD) symptoms in veterans, which complementary and alternative (CA) treatments are most effective, and how individual differences predict treatment efficacy.

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Sudarshan Kriya Yoga; Behavioral: Mindfulness-Based Stress Reduction

Detailed Description

The overarching purpose of this study is to assess the impact of CA interventions on posttraumatic stress symptoms in veterans with PTSD. Twenty percent of the approximately 2 million veterans returning from Iraq and Afghanistan ("Operation Iraqi Freedom" or OIF and "Operation Enduring Freedom" or OEF) suffer from the symptoms of Post-traumatic Stress Disorder. PTSD may be the reason behind alarming increases in suicidal behavior among returning veterans in Wisconsin and nation-wide. In addition to traditional treatments, Veterans Administration (VA) Hospitals and other community institutions for veterans now offer CA programs to their patients. Past research from our laboratory and others suggests that CA programs may provide effective relief from anxiety while increasing psychological well-being. However, little research exists on the effects of CA programs for combat veterans with PTSD. The proposed study aims to address this important gap by assessing CA programs such as Sudarshan Kriya Yoga (SKY) and Mindfulness-Based Stress Reduction (MBSR). 150 veterans with PTSD will be randomly assigned to either SKY, MBSR, or the wait-list control (WLC) group. We will assess participants' PTSD symptoms pre-intervention, post-intervention (approximately 10-14 days after initial visit), and 1 month post-treatment (approximately 6 weeks after initial visit). In order to evaluate the programs' effects as comprehensively as possible, we propose a multi-method approach: baseline psychophysiology, autonomic reactivity and recovery, neuropsychological (cognitive) assessments, self-report questionnaires, and functional brain imaging (fMRI). Baseline measures will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Waisman Center, University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• In the age range of 18-50.
• Capable of giving informed consent
• Fluent in English
• Exposure to one or more life-threatening war zone trauma events in Iraq or Afghanistan within the last 8 years.
• Pharmacological or psychotherapeutic treatment stable for at least 8 weeks prior to beginning of study
• Good general medical health (see Medical Exclusion Criteria)
• DSM-IV criteria for current PTSD as determined by CAPS (PTSD groups only)
• Combat-exposed, non-PTSD control veterans must be free of any current DSM-IV Axis I disorder
• Participants must agree to not begin a new course of treatment for the duration of the study

Exclusion Criteria:

• Weight of 352 pounds or over (due to constraints of MRI scanner)
• Women who are pregnant, planning to conceive during the research timeline, or breastfeeding will be excluded.
• Metallic implants such as prostheses or aneurysm clip, or electronic implants such as cardiac pacemakers
• Neurological or serious medical condition that may contraindicate MRI or that may overlap with physiological substrates of psychiatric conditions (see below for descriptions)
• History of seizures or seizure disorder
• Moderate or severe traumatic brain injury (over 30 minutes unconscious)
• Current active substance dependence or dependence within 3 months (other than nicotine)
• Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder NOS, delirium, or any DSM-IV cognitive disorder.
• Substance dependence disorder within 3 months or any current substance dependence
• Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to patient or others.
• Current use of benzodiazepines or beta-blockers
• Nonsuicidal depression comorbid with PTSD will NOT be exclusionary
• Extensive experience in yoga and meditation or have learned MBSR or SKY previously

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sudarshan Kriya Yoga: SKY; SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment. All are soothing and present-focused. Participants will be encouraged to learn all the breathing exercises, and to utilize the exercises the ones that seems most appropriate for their needs. 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3 hours/session).	Behavioral: Sudarshan Kriya Yoga; SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.; Other Names: yoga; SKY
Experimental: Mindfulness-Based Stress Reduction: MBSR; MBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts, allowing the practitioner to calm his or her mind and come back to the present moment. The typical MBSR format will be adapted to match the SKY intervention. This intervention will include an 8-day intensive group class (2.5 hours/day) followed by 4 weekly sessions (3hrs/session).	Behavioral: Mindfulness-Based Stress Reduction; MBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts; Other Names: MBSR; meditation; mindfulness
No Intervention: Wait-List Control: WLC; Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study.
No Intervention: Non-PTSD control; Baseline measures only will be collected from a group of 50 combat-exposed veterans without PTSD to assess group differences on these measures prior to treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician-Administered PTSD Scale (CAPS) scores		Baseline, 1 month post-intervention (approx. 6 weeks)
Change in PTSD Checklist-Military (PCL-M) scores		Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Change in fMRI brain blood oxygen level-dependent (BOLD) responses	Brain activation during anticipation of, response to, and recovery from aversive stimuli will be measured at baseline, and the intervention groups will be compared to the wait-list controls following the intervention to assess changes based on the interventions.	Baseline, post-intervention (approx 10-14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep	Sleep quality will be assessed using actigraphy	Baseline through one month post-intervention (approx. 6 weeks)
Changes in self-reported mood, anxiety, and sleep symptoms		Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Changes in peripheral psychophysiological arousal	Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.	Baseline and post-intervention (approx. 10-14 days)
Changes in neuropsychological functioning	Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox	Baseline, post-intervention (approx. 10-14 days)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: The Dana Foundation
• Investigators: Principal Investigator: Richard J Davidson, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: PTSD; Meditation; MRI, Functional; Veterans' Health
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2011-0641