NCT01957371

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

September 29, 2013

Last Update Submit

December 8, 2014

Conditions

PTSDChronic Pain

Keywords

PTSDYogaComplementary and Alternative Medicine (CAM)Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • Posttraumatic Stress Disorder Checklist - Military Version (PCL-M)

    A 17-item self- report measure of PTSD symptoms.

    24 weeks

  • Numeric Rating Scale of Pain Intensity (NRS-I)

    Global pain intensity will be assessed using the NRS-I, an 11-point numeric rating scale where a score of "0" represents no pain and a score of "10" represents the worst pain imaginable. Participants will be asked to rate their average current pain (e.g. today's pain) along with their average pain over the past week.

    24 weeks

Secondary Outcomes (13)

  • West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I)

    24 weeks

  • Mindful Yoga Therapy Evaluation of Treatment Questionnaire

    24 weeks

  • Pain Treatment Credibility Questionnaire

    24 weeks

  • Pain Treatment Satisfaction Questionnaire

    24 weeks

  • Beck Depression Inventory (BDI)

    24 Weeks

  • +8 more secondary outcomes

Other Outcomes (4)

  • Active Range of Motion

    24 weeks

  • YMCA Sit and Reach Test

    24 weeks

  • 90-90 Hamstring Test

    24 weeks

  • +1 more other outcomes

Study Arms (1)

Mindful Yoga Therapy

EXPERIMENTAL

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

Behavioral: Mindful Yoga Therapy

Interventions

Mindful Yoga TherapyBEHAVIORAL

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.

Mindful Yoga Therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Va Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticChronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alicia Heapy, Ph.D.

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

US(1)