Back to resultsStress Management for Chronic Headaches
Primary Purpose
Headaches
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anger Awareness and Expression
Relaxation Training
Sponsored by
About this trial
This is an interventional treatment trial for Headaches focused on measuring headaches, stress management, assertiveness training, relaxation training, emotional expression
Eligibility 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
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Anger awareness and expression
Relaxation Training
No-treatment control
Arm Description
Training for anger awareness and expression
Teach patients relaxation training
Assessment only control condition
Outcomes
Primary Outcome Measures
Headache frequency and severity
Secondary Outcome Measures
Headache disability
Mood, self-efficacy, stress symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956969
Brief Title
Stress Management for Chronic Headaches
Official Title
Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headaches
Keywords
headaches, stress management, assertiveness training, relaxation training, emotional expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anger awareness and expression
Arm Type
Experimental
Arm Description
Training for anger awareness and expression
Arm Title
Relaxation Training
Arm Type
Active Comparator
Arm Description
Teach patients relaxation training
Arm Title
No-treatment control
Arm Type
No Intervention
Arm Description
Assessment only control condition
Intervention Type
Behavioral
Intervention Name(s)
Anger Awareness and Expression
Intervention Description
Teaches patients to recognize, experience, and express emotions
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Teaches patients relaxation training
Primary Outcome Measure Information:
Title
Headache frequency and severity
Time Frame
baseline, 6-weeks, 6-months
Secondary Outcome Measure Information:
Title
Headache disability
Time Frame
baseline, 6-weeks, 6-months
Title
Mood, self-efficacy, stress symptoms
Time Frame
baseline and 6-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Lumley, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Management for Chronic Headaches
We'll reach out to this number within 24 hrs