Study Stopped
Did not have funding or resources to carry out study
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 19, 2014
December 1, 2014
2.4 years
January 19, 2012
December 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinician Administered PTSD Scale (CAPS)
The "gold standard" measure of frequency and intensity of PTSD symptoms.
12 weeks
Study Arms (2)
Arm 1
EXPERIMENTAL12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Arm 2
OTHER12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Interventions
Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Participants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Eligibility Criteria
You may qualify if:
- OEF/OIF/OND Veteran
- Ages 18-45
- Currently enrolled in active PTSD treatment
- Meet criteria for PTSD
- Veteran with combat exposure during deployment
You may not qualify if:
- Current psychotic disorder or bipolar disorder
- Current use of beta-blocker medication
- Current regular yoga or meditation practice in the past month
- Significant limitations or injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alicia Heapy, Ph.D.
VA Connecticut Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 30, 2012
Study Start
April 1, 2013
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
December 19, 2014
Record last verified: 2014-12