Clinical trial NCT01957371: Mindful Yoga Therapy for Veterans With PTSD and Pain
Official title: Mindful Yoga Therapy as an Adjunctive Treatment for Veterans With PTSD and Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Chronic Pain
Keywords: PTSD
Yoga
Complementary and Alternative Medicine (CAM)
Chronic Pain
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2013-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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: 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.

Eligibility criteria: 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)
* Comorbid conditions, including substance abuse/dependence will be allowed except as noted under 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)
timeFrame: 24 weeks
measure: Numeric Rating Scale of Pain Intensity (NRS-I)
timeFrame: 24 weeks
Secondary outcomes:
measure: West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I)
timeFrame: 24 weeks
measure: Mindful Yoga Therapy Evaluation of Treatment Questionnaire
timeFrame: 24 weeks
measure: Pain Treatment Credibility Questionnaire
timeFrame: 24 weeks
measure: Pain Treatment Satisfaction Questionnaire
timeFrame: 24 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 24 Weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 24 weeks
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 24 weeks
measure: Military Sexual Trauma
timeFrame: 24 weeks
measure: State-Trait Anger Scale (STAS)
timeFrame: 24 weeks
measure: Quality of Life (QOL)
timeFrame: 24 Weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 24 weeks
measure: Kentucky Inventory of Mindfulness Skills (KIMS)
timeFrame: 24 weeks
measure: Anxiety Sensitivity Index (ASI)
timeFrame: 24 weeks
Other outcomes:
measure: Active Range of Motion
timeFrame: 24 weeks
measure: YMCA Sit and Reach Test
timeFrame: 24 weeks
measure: 90-90 Hamstring Test
timeFrame: 24 weeks
measure: Balance Test
timeFrame: 24 weeks
Locations:
city: West Haven
country: United States
facility: Va Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Alicia Heapy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: