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Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

Primary Purpose

PTSD

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sudarshan Kriya Yoga

Mindfulness-Based Stress Reduction

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Veterans' Health, Meditation, MRI, Functional

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Waisman Center, University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Sudarshan Kriya Yoga: SKY

Mindfulness-Based Stress Reduction: MBSR

Wait-List Control: WLC

Non-PTSD control

Arm Description

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).

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).

Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study.

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.

Outcomes

Primary Outcome Measures

Change in Clinician-Administered PTSD Scale (CAPS) scores

Change in PTSD Checklist-Military (PCL-M) scores

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.

Secondary Outcome Measures

Quality of sleep

Sleep quality will be assessed using actigraphy

Changes in self-reported mood, anxiety, and sleep symptoms

Changes in peripheral psychophysiological arousal

Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.

Changes in neuropsychological functioning

Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox

Full Information

NCT ID

NCT01512303

First Posted

January 6, 2012

Last Updated

May 1, 2018

Sponsor

University of Wisconsin, Madison

Collaborators

The Dana Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01512303

Brief Title

Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Study terminated due to funding issues

Study Start Date

April 2012 (Actual)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

The Dana Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD

Keywords

PTSD, Veterans' Health, Meditation, MRI, Functional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sudarshan Kriya Yoga: SKY

Arm Type

Experimental

Arm Description

Arm Title

Mindfulness-Based Stress Reduction: MBSR

Arm Type

Experimental

Arm Description

Arm Title

Wait-List Control: WLC

Arm Type

No Intervention

Arm Description

Participants will undergo no intervention. These participants will have the option of receiving one of the two interventions at the conclusion of the study.

Arm Title

Non-PTSD control

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sudarshan Kriya Yoga

Other Intervention Name(s)

SKY, yoga

Intervention Description

SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-Based Stress Reduction

Other Intervention Name(s)

MBSR, mindfulness, meditation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Clinician-Administered PTSD Scale (CAPS) scores

Time Frame

Baseline, 1 month post-intervention (approx. 6 weeks)

Title

Change in PTSD Checklist-Military (PCL-M) scores

Time Frame

Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)

Title

Change in fMRI brain blood oxygen level-dependent (BOLD) responses

Description

Time Frame

Baseline, post-intervention (approx 10-14 days)

Secondary Outcome Measure Information:

Title

Quality of sleep

Description

Sleep quality will be assessed using actigraphy

Time Frame

Baseline through one month post-intervention (approx. 6 weeks)

Title

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)

Title

Changes in peripheral psychophysiological arousal

Description

Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.

Time Frame

Baseline and post-intervention (approx. 10-14 days)

Title

Changes in neuropsychological functioning

Description

Memory, attention, and rapid perceptual processing will be measured using neuropsychological tasks by Cambridge Cognition and/or the NIH toolbox

Time Frame

Baseline, post-intervention (approx. 10-14 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J Davidson, PhD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

Waisman Center, University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

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Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

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