NCT01993069

Brief Summary

The objective of the study is to evaluate the efficacy of a yoga treatment for veterans with mild post-traumatic and chronic tension-type headaches. Study Aims:

  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, assist in decreasing headaches and associated symptoms?
  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tensions-type headaches experience, assist in improving quality of life?
  • Does this yoga treatment, targeted toward specific symptoms veterans with mild post-traumatic and chronic tension-type headaches experience, improve mood?
  • Do the effects of yoga on symptoms, mood, and quality of life maintain 2 months post completion of treatment?

Trial Health

57
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

July 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 year 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

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

July 16, 2013

Last Update Submit

May 1, 2017

Conditions

Post Traumatic HeadacheChronic Daily Headache

Outcome Measures

Primary Outcomes (1)

  • Symptom relief, headache

    Post-Treatment, up to 2 months

Study Arms (1)

Iyengar-based Yoga Training

EXPERIMENTAL

6 weekly Iyengar-based yoga classes

Behavioral: Iyengar-based Yoga Training

Interventions

Iyengar-based Yoga TrainingBEHAVIORAL

6 weekly Iyengar-based yoga classes

Iyengar-based Yoga Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bruce Naliboff, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Milena Zirovich, MD

    VAGLAHS

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 16, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

US(1)