Stress Management for Chronic Headaches

Headaches Clinical Trial

Official title:

Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956969
• Other study ID #: WSU0000001
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: June 13, 2013
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headaches

Intervention

Behavioral:
• Anger Awareness and Expression
Teaches patients to recognize, experience, and express emotions
• Relaxation Training
Teaches patients relaxation training

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency and severity		baseline, 6-weeks, 6-months	No
Secondary	Headache disability		baseline, 6-weeks, 6-months	No
Secondary	Mood, self-efficacy, stress symptoms		baseline and 6-weeks	No