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Mindful Yoga Therapy for Veterans With PTSD and Pain

NCT ID: NCT01957371

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-11-30

Brief Summary

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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) and chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore anxiety sensitivity as a mechanism of therapeutic action.

Detailed Description

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PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive, and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.

Mindful Yoga Therapy (MYT) is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot clinical trial will examine the efficacy of MYT with baseline, 12 week, and 24 week follow-up assessments that will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to the study purpose.

Conditions

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PTSD Chronic Pain

Keywords

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PTSD Yoga Complementary and Alternative Medicine (CAM) Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindful Yoga Therapy

12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.

Group Type EXPERIMENTAL

Mindful Yoga Therapy

Intervention Type BEHAVIORAL

Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice.

Interventions

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Mindful Yoga Therapy

Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* OIF/OEF/OND Veteran
* Ages 18-45
* A willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks.
* Currently enrolled (under active care) at the PTSD firm or the MST group at VACHS, West Haven
* Participants will meet clinical criteria of PTSD (DSM-IV-TR)

Exclusion Criteria

* Veteran with combat exposure or military sexual trauma during deployment(s).
* Non-cancer pain score (NRS pain score \> 4 on a 0-10 scale whereby 0=no pain and 10=worst pain imaginable) and presence of pain for \>3 consecutive months


* Any diagnosis of current comorbid psychotic disorders or bipolar disorder
* Active SI/HI
* Primary and only pain complaint as headache disorder
* A regular yoga or meditation practice in past month (more than twice weekly)
* Participants with significant limitations or injuries (Potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.)
* Inability to speak or read English
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Connecticut Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alicia Heapy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Healthcare System

Locations

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Va Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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01735

Identifier Type: -

Identifier Source: org_study_id