Stress Management for Chronic Headaches
Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches
1 other identifier
interventional
147
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
1 active site
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
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 17, 2013
June 1, 2013
1.7 years
August 10, 2009
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache frequency and severity
baseline, 6-weeks, 6-months
Secondary Outcomes (2)
Headache disability
baseline, 6-weeks, 6-months
Mood, self-efficacy, stress symptoms
baseline and 6-weeks
Study Arms (3)
Anger awareness and expression
EXPERIMENTALTraining for anger awareness and expression
Relaxation Training
ACTIVE COMPARATORTeach patients relaxation training
No-treatment control
NO INTERVENTIONAssessment only control condition
Interventions
Teaches patients to recognize, experience, and express emotions
Eligibility Criteria
You may qualify if:
- Undergraduate students at Wayne State University who have chronic headaches
You may not qualify if:
- Insufficiently frequent headaches
- Uninterested in engaging in a stress management intervention
- Headaches appear due to substance use or head trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A. Lumley, Ph.D.
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 17, 2013
Record last verified: 2013-06