Stress Management for Chronic Headaches

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. Identifier: NCT00956969
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : June 17, 2013
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University

Brief Summary:
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 or disease Intervention/treatment Phase
Headaches Behavioral: Anger Awareness and Expression Behavioral: Relaxation Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00956969

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

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

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

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