NCT01717547

Brief Summary

The aims of this research study are to 1) assess the acceptability and feasibility of conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on Veteran's mental health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

August 29, 2012

Last Update Submit

October 31, 2018

Conditions

Keywords

VeteransYogaStress

Outcome Measures

Primary Outcomes (1)

  • Change in Psychological Distress

    Change in OQ 45 Scores pre and post intervention

    Change from baseline to approximately 8 weeks

Secondary Outcomes (1)

  • Change in Acceptability

    Change in baseline up to 8 weeks post

Study Arms (1)

Yoga

EXPERIMENTAL

Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.

Behavioral: Yoga-based treatment

Interventions

Yoga

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Veterans receiving care by a primary care provider at DVAMC
  • Between the ages of 18 and 50
  • Able to provide informed consent
  • Able to adequately answer comprehension questions
  • Documented VA primary care provider medical clearance to participate in the study as noted on the medical clearance form

You may not qualify if:

  • Veterans younger than 18, or older than 50 years of age
  • Inability to provide informed consent
  • Inability to answer comprehension questions
  • Meet criteria for active substance dependence, excluding Cannabis dependence as determined by clinical interview
  • Identification of active psychosis as determined by clinical interview
  • Documentation on the medical clearance form by VA primary care provider which suggests barriers to Veteran participation
  • Veterans whom have sustained an amputation and/or whom have limited physical mobility as documented by the VA primary care provider
  • Veterans already participating in an ongoing yoga practice of up to two times weekly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Veterans Affairs Medical Center

Denver, Colorado, 80220, United States

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lisa Brenner, PhD

    VA ECHCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 29, 2012

First Posted

October 30, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 2, 2018

Record last verified: 2018-10

Locations