Stress Management for Chronic Headaches

June 13, 2013 updated by: Mark A. Lumley, Wayne State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache frequency and severity
Time Frame: baseline, 6-weeks, 6-months
baseline, 6-weeks, 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Headache disability
Time Frame: baseline, 6-weeks, 6-months
baseline, 6-weeks, 6-months
Mood, self-efficacy, stress symptoms
Time Frame: baseline and 6-weeks
baseline and 6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Investigators

  • Principal Investigator: Mark A. Lumley, Ph.D., Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSU0000001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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