Yoga Training for Returning Veterans With Headache

Sponsor
University of California, Los Angeles (Other)
Overall Status
Terminated
CT.gov ID
NCT01993069
Collaborator
(none)
20
1
1
14
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Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Iyengar-based Yoga Training
N/A

Detailed Description

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. The yoga will be provided in the form of 6 weekly yoga sessions aimed at providing direct instruction and immediate feedback on postures, breathing, and relaxation techniques in a small group format. The sessions will be led by an experienced yoga instructor who is a part of the study team and have worked with medical patients. A post-yoga 2-month follow-up assessment of self-reported symptoms, mood, and quality of life will also be assessed.

This is a feasibility study to determine if a yoga treatment is received favorably and can be successfully delivered to veterans seeking treatments for post-traumatic and chronic tension-type headaches. This study does not include a comparison group; therefore, we can only make conclusions based on pre to post differences in subjects who participate in the yoga. Our aim for this study is to collect data on the potential benefits of a targeted yoga treatment for symptoms experienced by these subjects, and to then utilize these data to implement a larger study with a comparison group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Yoga Training for Returning Veterans With Headache
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iyengar-based Yoga Training

6 weekly Iyengar-based yoga classes

Behavioral: Iyengar-based Yoga Training
6 weekly Iyengar-based yoga classes

Outcome Measures

Primary Outcome Measures

  1. Symptom relief, headache [Post-Treatment, up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Eligibility determined at screening will be based on the following inclusion criteria: Mild post traumatic headaches or chronic tension-type headaches, diagnosed by a physician. Inclusion criteria also includes the following: 1). Ability to participate in yoga classes (i.e., no physical limitations, mobility issues, or severe chronic medical issues/symptoms such as severe chronic back pain or injury, amputees, being wheelchair bound), 2). Not current involved in regular yoga of more than an hour of yoga per week in a formal setting, 3). If a woman, not currently pregnant or breast feeding, 4). Ages 18 and up (no maximal age limit), 5). Veterans only (no non-veteran populations), and 6). Not currently suffering from severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder), a history of psychiatric hospitalization, or current substance abuse or dependence.

Exclusion Criteria:

Exclusion based on the following: 1). Age less than 18 years old (not an adult); 2). Not a veteran; 3). Physical limitations, mobility issues, or severe chronic medical issues that may impede one's ability to participate in yoga classes (e.g., wheelchair bound veterans, amputees, those with severe musculoskeletal or nerve pain or injury such as chronic back pain with significantly limited range of motion); 4). Current severe psychiatric diagnoses (e.g., schizophrenia, bipolar disorder) or history of psychiatric hospitalizations; 5). Current substance abuse or dependence; 6). Current regular yoga practice involving more than an hour of yoga per week in a formal setting; and 7). If a woman, currently pregnant or breast feeding.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Greater Los Angeles Healthcare System Los Angeles California United States 90073

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

  • Principal Investigator: Bruce Naliboff, PhD, University of California, Los Angeles
  • Principal Investigator: Milena Zirovich, MD, VAGLAHS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bruce Naliboff, PhD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01993069
Other Study ID Numbers:
  • PCC 2013-020286
First Posted:
Nov 25, 2013
Last Update Posted:
May 2, 2017
Last Verified:
May 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2017