Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01512303
• Other study ID #: 2011-0641
• Status: Terminated
• Phase: N/A
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Sudarshan Kriya Yoga
SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.
• 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

Locations

Country	Name	City	State
United States	Waisman Center, University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	The Dana Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician-Administered PTSD Scale (CAPS) scores		Baseline, 1 month post-intervention (approx. 6 weeks)
Primary	Change in PTSD Checklist-Military (PCL-M) scores		Baseline, Post-Intervention (approx. 10-14 days), 1 month post-intervention (approx. 6 weeks)
Primary	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.	Baseline, post-intervention (approx 10-14 days)
Secondary	Quality of sleep	Sleep quality will be assessed using actigraphy	Baseline through one month post-intervention (approx. 6 weeks)
Secondary	Changes in self-reported mood, anxiety, and sleep symptoms		Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)
Secondary	Changes in peripheral psychophysiological arousal	Assessed using multiple measures, including heart rate, heart rate variability, corrugator EMG, and skin conductance.	Baseline and post-intervention (approx. 10-14 days)
Secondary	Changes in neuropsychological functioning	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)

External Links

•   Study information page