Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

May 1, 2018 updated by: University of Wisconsin, Madison

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Clinician-Administered PTSD Scale (CAPS) scores
Time Frame: Baseline, 1 month post-intervention (approx. 6 weeks)
Baseline, 1 month post-intervention (approx. 6 weeks)
Change in PTSD Checklist-Military (PCL-M) scores
Time Frame: Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Change in fMRI brain blood oxygen level-dependent (BOLD) responses
Time Frame: Baseline, post-intervention (approx 10-14 days)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of sleep
Time Frame: Baseline through one month post-intervention (approx. 6 weeks)
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
Time Frame: Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Changes in peripheral psychophysiological arousal
Time Frame: Baseline and post-intervention (approx. 10-14 days)
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
Time Frame: Baseline, post-intervention (approx. 10-14 days)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Dana Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard J Davidson, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-0641

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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