Stress Management for Chronic Headaches | NCT00956969

Studies
Stress Management for Chronic Headaches

NCT00956969

Sponsor

Wayne State University

Status

Completed

Last Update Posted

Jun 17, 2013Estimated

Enrollment

147Actual

Phase

Not Applicable

Conditions

Headaches

Interventions

Anger Awareness and Expression
Relaxation Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2013

Last Update Posted Date

Jun 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Anger Awareness and Expression	Behavioral	Teaches patients to recognize, experience, and express emotions	Anger awareness and expression

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A. Lumley, Ph.D.	Wayne State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wayne State University		Detroit	Michigan	48202	United States

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015870	Gene Expression
D012064	Relaxation Therapy

Ancestor Terms

ID	Term
D055614	Genetic Phenomena
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided