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Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512303
Enrollment
70
Registered
2012-01-19
Start date
2012-04-30
Completion date
2013-05-31
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

PTSD, Veterans' Health, Meditation, MRI, Functional

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.

Interventions

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

BEHAVIORALMindfulness-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

Sponsors

The Dana Foundation
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinician-Administered PTSD Scale (CAPS) scoresBaseline, 1 month post-intervention (approx. 6 weeks)
Change in PTSD Checklist-Military (PCL-M) scoresBaseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Change in fMRI brain blood oxygen level-dependent (BOLD) responsesBaseline, 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.

Secondary

MeasureTime frameDescription
Quality of sleepBaseline through one month post-intervention (approx. 6 weeks)Sleep quality will be assessed using actigraphy
Changes in neuropsychological functioningBaseline, 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
Changes in self-reported mood, anxiety, and sleep symptomsBaseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Changes in peripheral psychophysiological arousalBaseline and post-intervention (approx. 10-14 days)Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026