{ "FullStudy":{ "Rank":218133, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512303", "OrgStudyIdInfo":{ "OrgStudyId":"2011-0641" }, "Organization":{ "OrgFullName":"University of Wisconsin, Madison", "OrgClass":"OTHER" }, "BriefTitle":"Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder", "OfficialTitle":"Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder: Community Program Evaluation Study" }, "StatusModule":{ "StatusVerifiedDate":"May 2018", "OverallStatus":"Terminated", "WhyStopped":"Study terminated due to funding issues", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 1, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 7, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University of Wisconsin, Madison", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"The Dana Foundation", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"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.", "DetailedDescription":"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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "PTSD" ] }, "KeywordList":{ "Keyword":[ "PTSD", "Veterans' Health", "Meditation", "MRI, Functional" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"70", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Sudarshan Kriya Yoga: SKY", "ArmGroupType":"Experimental", "ArmGroupDescription":"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).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Sudarshan Kriya Yoga" ] } },{ "ArmGroupLabel":"Mindfulness-Based Stress Reduction: MBSR", "ArmGroupType":"Experimental", "ArmGroupDescription":"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).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Mindfulness-Based Stress Reduction" ] } },{ "ArmGroupLabel":"Wait-List Control: WLC", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study." },{ "ArmGroupLabel":"Non-PTSD control", "ArmGroupType":"No Intervention", "ArmGroupDescription":"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." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Sudarshan Kriya Yoga", "InterventionDescription":"SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sudarshan Kriya Yoga: SKY" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "SKY", "yoga" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Mindfulness-Based Stress Reduction", "InterventionDescription":"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", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mindfulness-Based Stress Reduction: MBSR" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "MBSR", "mindfulness", "meditation" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Clinician-Administered PTSD Scale (CAPS) scores", "PrimaryOutcomeTimeFrame":"Baseline, 1 month post-intervention (approx. 6 weeks)" },{ "PrimaryOutcomeMeasure":"Change in PTSD Checklist-Military (PCL-M) scores", "PrimaryOutcomeTimeFrame":"Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)" },{ "PrimaryOutcomeMeasure":"Change in fMRI brain blood oxygen level-dependent (BOLD) responses", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"Baseline, post-intervention (approx 10-14 days)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Quality of sleep", "SecondaryOutcomeDescription":"Sleep quality will be assessed using actigraphy", "SecondaryOutcomeTimeFrame":"Baseline through one month post-intervention (approx. 6 weeks)" },{ "SecondaryOutcomeMeasure":"Changes in self-reported mood, anxiety, and sleep symptoms", "SecondaryOutcomeTimeFrame":"Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)" },{ "SecondaryOutcomeMeasure":"Changes in peripheral psychophysiological arousal", "SecondaryOutcomeDescription":"Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.", "SecondaryOutcomeTimeFrame":"Baseline and post-intervention (approx. 10-14 days)" },{ "SecondaryOutcomeMeasure":"Changes in neuropsychological functioning", "SecondaryOutcomeDescription":"Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox", "SecondaryOutcomeTimeFrame":"Baseline, post-intervention (approx. 10-14 days)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nIn the age range of 18-50.\nCapable of giving informed consent\nFluent in English\nExposure to one or more life-threatening war zone trauma events in Iraq or Afghanistan within the last 8 years.\nPharmacological or psychotherapeutic treatment stable for at least 8 weeks prior to beginning of study\nGood general medical health (see Medical Exclusion Criteria)\nDSM-IV criteria for current PTSD as determined by CAPS (PTSD groups only)\nCombat-exposed, non-PTSD control veterans must be free of any current DSM-IV Axis I disorder\nParticipants must agree to not begin a new course of treatment for the duration of the study\n\nExclusion Criteria:\n\nWeight of 352 pounds or over (due to constraints of MRI scanner)\nWomen who are pregnant, planning to conceive during the research timeline, or breastfeeding will be excluded.\nMetallic implants such as prostheses or aneurysm clip, or electronic implants such as cardiac pacemakers\nNeurological or serious medical condition that may contraindicate MRI or that may overlap with physiological substrates of psychiatric conditions (see below for descriptions)\nHistory of seizures or seizure disorder\nModerate or severe traumatic brain injury (over 30 minutes unconscious)\nCurrent active substance dependence or dependence within 3 months (other than nicotine)\nMeets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder NOS, delirium, or any DSM-IV cognitive disorder.\nSubstance dependence disorder within 3 months or any current substance dependence\nSevere 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.\nCurrent use of benzodiazepines or beta-blockers\nNonsuicidal depression comorbid with PTSD will NOT be exclusionary\nExtensive experience in yoga and meditation or have learned MBSR or SKY previously", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Richard J Davidson, PhD", "OverallOfficialAffiliation":"University of Wisconsin, Madison", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Waisman Center, University of Wisconsin", "LocationCity":"Madison", "LocationState":"Wisconsin", "LocationZip":"53705", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Study information page", "SeeAlsoLinkURL":"http://www.investigatinghealthyminds.org/cihmParticipate.html#veteransWellness" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013313", "ConditionMeshTerm":"Stress Disorders, Post-Traumatic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000040921", "ConditionAncestorTerm":"Stress Disorders, Traumatic" },{ "ConditionAncestorId":"D000068099", "ConditionAncestorTerm":"Trauma and Stressor Related Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M23503", "ConditionBrowseLeafName":"Stress Disorders, Traumatic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14686", "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic", "ConditionBrowseLeafAsFound":"Posttraumatic Stress Disorder", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M222", "ConditionBrowseLeafName":"Trauma and Stressor Related Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }