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Stress Management for Chronic Headaches

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
ClinicalTrials.gov Identifier:
NCT00956969
First received: August 10, 2009
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Headache frequency and severity [ Time Frame: baseline, 6-weeks, 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Headache disability [ Time Frame: baseline, 6-weeks, 6-months ] [ Designated as safety issue: No ]
  • Mood, self-efficacy, stress symptoms [ Time Frame: baseline and 6-weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00956969     History of Changes
Other Study ID Numbers: WSU0000001
Study First Received: August 10, 2009
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013