NCT00956969

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

1.7 years

First QC Date

August 10, 2009

Last Update Submit

June 13, 2013

Conditions

Keywords

headachesstress managementassertiveness trainingrelaxation trainingemotional expression

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

EXPERIMENTAL

Training for anger awareness and expression

Behavioral: Anger Awareness and Expression

Relaxation Training

ACTIVE COMPARATOR

Teach patients relaxation training

Behavioral: Relaxation Training

No-treatment control

NO INTERVENTION

Assessment only control condition

Interventions

Teaches patients to recognize, experience, and express emotions

Anger awareness and expression

Teaches patients relaxation training

Relaxation Training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Headache

Interventions

Gene ExpressionRelaxation Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark A. Lumley, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

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

Locations