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Stress Management for Chronic Headaches

This study has been completed.
Sponsor:
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT00956969
First received: August 10, 2009
Last updated: June 17, 2011
Last verified: June 2011
History of Changes

August 10, 2009
June 17, 2011
September 2009
May 2011   (final data collection date for primary outcome measure)
Headache frequency and severity [ Time Frame: baseline, 6-weeks, 6-months ] [ Designated as safety issue: No ]
Headache frequency and severity [ Time Frame: baseline, 6-weeks, 3-,6-, and 12-months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956969 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Headache disability [ Time Frame: baseline, 6-weeks, 3-,6-, and 12-months ] [ Designated as safety issue: No ]
  • Mood, self-efficacy, stress symptoms [ Time Frame: baseline and 6-weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Stress Management for Chronic Headaches
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Headaches
Behavioral: Small group training in stress management skills
3, 1-hour sessions of small groups (4-6 participants), meeting weekly for 3 weeks, with homework assigned between sessions
  • Experimental: Emotion awareness and expression
    Participants will have 3 small group sessions in which they are taught to recognize and express anger, particularly using an assertiveness training format
    Intervention: Behavioral: Small group training in stress management skills
  • Active Comparator: Relaxation Training
    Participants will have 3 sessions of relaxation training, including progressive muscle, breathing retraining, autogenic training, and applied relaxation
    Intervention: Behavioral: Small group training in stress management skills
  • No Intervention: No-treatment control
    Assessment only control condition
    Intervention: Behavioral: Small group training in stress management skills
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956969
WSU0000001
No
Mark A. Lumley, Ph.D., Professor, Department of Psychology, Wayne State University
Wayne State University
Not Provided
Principal Investigator: Mark A. Lumley, Ph.D. Wayne State University
Wayne State University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP