HeadachesNCT00956969
Stress Management for Chronic Headaches
A study testing Anger Awareness and Expression and Relaxation Training in people with Headaches, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headaches
- What is being tested?
- Anger Awareness and Expression and Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergraduate students at Wayne State University who have chronic headaches
Who cannot join
- Insufficiently frequent headaches
- Uninterested in engaging in a stress management intervention
- Headaches appear due to substance use or head trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Headaches
- Being tested
- Anger Awareness and Expression, Relaxation Training
- Keywords
- headaches, stress management, assertiveness training, relaxation training, emotional expression
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger Awareness and ExpressionBehavioural
Teaches patients to recognize, experience, and express emotions
Relaxation TrainingBehavioural
Teaches patients relaxation training
| Study group | Role | What they receive |
|---|---|---|
| Anger awareness and expression | Experimental | Training for anger awareness and expression Receives: Behavioral: Anger Awareness and Expression |
| Relaxation Training | Active comparator | Teach patients relaxation training Receives: Behavioral: Relaxation Training |
| No-treatment control | No intervention | Assessment only control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency and severity
Measured: baseline, 6-weeks, 6-months
Secondary outcomes (2)
Headache disability
Measured: baseline, 6-weeks, 6-months
Mood, self-efficacy, stress symptoms
Measured: baseline and 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark A. Lumley, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956969
- Sponsor's protocol ID
- WSU0000001
- Status last verified
- Jun 2013
- First submitted
- 10 Aug 2009
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Awareness and Expression Training and Relaxation Training for People With Chronic Headaches
- ClinicalTrials.gov ID
- NCT00956969
- Acronym / sponsor ID
- WSU0000001
- Conditions
- Headaches
- Keywords
- headaches, stress management, assertiveness training, relaxation training, emotional expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anger awareness and expression | Experimental | Behavioral: Anger Awareness and ExpressionTraining for anger awareness and expression |
| Relaxation Training | Active comparator | Behavioral: Relaxation TrainingTeach patients relaxation training |
| No-treatment control | No intervention | –Assessment only control condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Undergraduate students at Wayne State University who have chronic headaches
Key exclusion criteria (3 listed)
- Insufficiently frequent headaches
- Uninterested in engaging in a stress management intervention
- Headaches appear due to substance use or head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anger Awareness and ExpressionTeaches patients to recognize, experience, and express emotions | Behavioural | Anger awareness and expression |
| Relaxation TrainingTeaches patients relaxation training | Behavioural | Relaxation Training |
Primary outcome
Headache frequency and severity
Time frame: baseline, 6-weeks, 6-months
2 secondary outcomes
Headache disability
Time frame: baseline, 6-weeks, 6-months
Mood, self-efficacy, stress symptoms
Time frame: baseline and 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Lumley, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anger Awareness and Expression and Relaxation Training in people with Headaches, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency and severity (time frame: baseline, 6-weeks, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.