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Stress Management for Chronic Headaches

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956969
First Posted: August 11, 2009
Last Update Posted: June 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
  Purpose
This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.

Condition Intervention
Headaches Behavioral: Anger Awareness and Expression Behavioral: Relaxation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches

Resource links provided by NLM:


Further study details as provided by Mark A. Lumley, Wayne State University:

Primary Outcome Measures:
  • Headache frequency and severity [ Time Frame: baseline, 6-weeks, 6-months ]

Secondary Outcome Measures:
  • Headache disability [ Time Frame: baseline, 6-weeks, 6-months ]
  • Mood, self-efficacy, stress symptoms [ Time Frame: baseline and 6-weeks ]

Enrollment: 147
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anger awareness and expression
Training for anger awareness and expression
Behavioral: Anger Awareness and Expression
Teaches patients to recognize, experience, and express emotions
Active Comparator: Relaxation Training
Teach patients relaxation training
Behavioral: Relaxation Training
Teaches patients relaxation training
No Intervention: No-treatment control
Assessment only control condition

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergraduate students at Wayne State University who have chronic headaches

Exclusion Criteria:

  • Insufficiently frequent headaches
  • Uninterested in engaging in a stress management intervention
  • Headaches appear due to substance use or head trauma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956969


Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark A. Lumley, Ph.D. Wayne State University
  More Information

Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00956969     History of Changes
Other Study ID Numbers: WSU0000001
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Mark A. Lumley, Wayne State University:
headaches
stress management
assertiveness training
relaxation training
emotional expression

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases