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Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by University of Wisconsin, Madison
Sponsor:
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01512303
First received: January 6, 2012
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
PTSD
Behavioral: Group-based meditation intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in Clinician-Administered PTSD Scale (CAPS) scores [ Time Frame: Baseline, 1 month post-intervention (approx. 6 weeks) ] [ Designated as safety issue: No ]
  • Change in PTSD Checklist-Military (PCL-M) scores [ Time Frame: Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks) ] [ Designated as safety issue: No ]
  • Change in fMRI brain blood oxygen level-dependent (BOLD) responses [ Time Frame: Baseline, post-intervention (approx 10-14 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of sleep [ Time Frame: Baseline through one month post-intervention (approx. 6 weeks) ] [ Designated as safety issue: No ]
    Sleep quality will be assessed using actigraphy

  • Changes in self-reported mood, anxiety, and sleep symptoms [ Time Frame: Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks) ] [ Designated as safety issue: No ]
  • Changes in peripheral psychophysiological arousal [ Time Frame: Baseline and post-intervention (approx. 10-14 days) ] [ Designated as safety issue: No ]
    Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.

  • Changes in neuropsychological functioning [ Time Frame: Baseline, post-intervention (approx. 10-14 days) ] [ Designated as safety issue: No ]
    Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sudarshan Kriya Yoga: SKY
SKY meditation 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: Group-based meditation intervention
Participants with PTSD who meet inclusion criteria will be randomly assigned to one of three groups: either one of two active interventions, or the wait-list. A control group will consist of combat veterans without PTSD.
Other Names:
  • meditation
  • mindfulness
  • yoga
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: Group-based meditation intervention
Participants with PTSD who meet inclusion criteria will be randomly assigned to one of three groups: either one of two active interventions, or the wait-list. A control group will consist of combat veterans without PTSD.
Other Names:
  • meditation
  • mindfulness
  • yoga
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.
Behavioral: Group-based meditation intervention
Participants with PTSD who meet inclusion criteria will be randomly assigned to one of three groups: either one of two active interventions, or the wait-list. A control group will consist of combat veterans without PTSD.
Other Names:
  • meditation
  • mindfulness
  • yoga
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.
Behavioral: Group-based meditation intervention
Participants with PTSD who meet inclusion criteria will be randomly assigned to one of three groups: either one of two active interventions, or the wait-list. A control group will consist of combat veterans without PTSD.
Other Names:
  • meditation
  • mindfulness
  • yoga

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512303

Contacts
Contact: Emma M Seppala, PhD 608-263-0803 seppala@wisc.edu
Contact: Daniel W Grupe, MS 608-265-6564 grupe@wisc.edu

Locations
United States, Wisconsin
Waisman Center, University of Wisconsin Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Emma M Seppala, PhD    608-263-0803    seppala@wisc.edu   
Contact: Daniel W Grupe, MS    608-265-6564    grupe@wisc.edu   
Principal Investigator: Emma M Seppala, PhD         
Sub-Investigator: Richard J Davidson, PhD         
Sub-Investigator: Jack B Nitschke, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
The Dana Foundation
Investigators
Principal Investigator: Emma M Seppala, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01512303     History of Changes
Other Study ID Numbers: 2011-0641
Study First Received: January 6, 2012
Last Updated: January 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
PTSD
Veterans' Health
Meditation
MRI, Functional

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014