Clinical trial NCT01512303: 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
Overall status: TERMINATED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Veterans' Health
Meditation
MRI, Functional
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: The Dana Foundation
First posted: 2012-01-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Clinician-Administered PTSD Scale (CAPS) scores
timeFrame: Baseline, 1 month post-intervention (approx. 6 weeks)
measure: Change in PTSD Checklist-Military (PCL-M) scores
timeFrame: Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
measure: Change in fMRI brain blood oxygen level-dependent (BOLD) responses
timeFrame: Baseline, post-intervention (approx 10-14 days)
Secondary outcomes:
measure: Quality of sleep
timeFrame: Baseline through one month post-intervention (approx. 6 weeks)
measure: Changes in self-reported mood, anxiety, and sleep symptoms
timeFrame: Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
measure: Changes in peripheral psychophysiological arousal
timeFrame: Baseline and post-intervention (approx. 10-14 days)
measure: Changes in neuropsychological functioning
timeFrame: Baseline, post-intervention (approx. 10-14 days)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Waisman Center, University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Richard J Davidson, PhD
role: PRINCIPAL_INVESTIGATOR
References: