Complementary and Alternative Interventions for Veterans With Posttraumatic Stress Disorder

NCT01512303 | Terminated

• 1 other identifier: 2011-0641
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD; Veterans' Health; Meditation; MRI, Functional

Outcome Measures

Primary Outcomes (3)

• Change in Clinician-Administered PTSD Scale (CAPS) scores

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

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

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

• 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 Outcomes (4)

• Quality of sleep

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

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

  Baseline, post-intervention (approx. 10-14 days), one month post-intervention (approx. 6 weeks)

• Changes in peripheral psychophysiological arousal

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

• Changes in neuropsychological functioning

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

Study Arms (4)

Sudarshan Kriya Yoga: SKY

EXPERIMENTAL

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

Mindfulness-Based Stress Reduction: MBSR

EXPERIMENTAL

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

Wait-List Control: WLC

NO INTERVENTION

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

Non-PTSD control

NO INTERVENTION

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.

Interventions

Sudarshan Kriya Yoga BEHAVIORAL

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

Also known as: SKY, yoga

Sudarshan Kriya Yoga: SKY

Mindfulness-Based Stress Reduction BEHAVIORAL

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

Also known as: MBSR, mindfulness, meditation

Mindfulness-Based Stress Reduction: MBSR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Extensive experience in yoga and meditation or have learned MBSR or SKY previously

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• The Dana Foundation: collaborator

Study Sites (1)

Waisman Center, University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Yoga; Mindfulness-Based Stress Reduction; Mindfulness; Meditation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy

Study Officials

• Richard J Davidson, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 19, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)