HeadacheNCT03183791
RELAXaHEAD for Headache Patients (Phase I)
A study testing RELAXaHEAD app in people with Headache and Migraine, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Headache, Migraine, Multiple Sclerosis
- What is being tested?
- RELAXaHEAD app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 25 May 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
- 4 or more headache days per month
Who cannot join
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine in the past year
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- Opioid or barbiturate use 10+ days a month
- Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
- Not having a smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).
- Conditions
- Headache, Migraine, Multiple Sclerosis
- Being tested
- RELAXaHEAD app, Monitored Usual Care (MUC)
- Medical subject headings
- Headache, Migraine Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAXaHEAD appBehavioural
The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.
Monitored Usual Care (MUC)Behavioural
The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
Subjects will be taught to enter their headache log daily on the app.
| Study group | Role | What they receive |
|---|---|---|
| RELAX group | Experimental | Not described Receives: Behavioral: RELAXaHEAD app |
| Monitored Usual Care (MUC) group | Active comparator | Not described Receives: Behavioral: Monitored Usual Care (MUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
Measure of feasibility
Measured: 90 Days
Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
Measure of feasibility
Measured: 90 Days
Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
Measure of feasibility
Measured: 90 Days
Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
Measure of acceptability
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Nov 2017
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Mia Minen, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183791
- Sponsor's protocol ID
- 17-00525
- Status last verified
- Feb 2020
- First submitted
- 8 Jun 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELAXaHEAD for Headache Patients (Phase I)
- ClinicalTrials.gov ID
- NCT03183791
- Acronym / sponsor ID
- 17-00525
- Conditions
- Headache, Migraine, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RELAX group | Experimental | Behavioral: RELAXaHEAD app |
| Monitored Usual Care (MUC) group | Active comparator | Behavioral: Monitored Usual Care (MUC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets migraine criteria based on International Classification of Headache Disorders (ICHD) 3 beta (based on questions in RedCap
- 4 or more headache days per month
Key exclusion criteria (6 listed)
- Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy for Migraine in the past year
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
- Opioid or barbiturate use 10+ days a month
- Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
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 |
|---|---|---|
| RELAXaHEAD appThe Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app. | Behavioural | RELAX group |
| Monitored Usual Care (MUC)The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive. Subjects will be taught to enter their headache log daily on the app. | Behavioural | Monitored Usual Care (MUC) group |
Primary outcome
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app
Time frame: 90 Days
Measure of feasibility
Number of days spent doing PMR as determined with the backend analytics in the RELAXaHEAD app backend analytics in the RELAXaHEAD app
Time frame: 90 Days
Measure of feasibility
Minutes/day spent doing PMR as determined with the backend analytics in the RELAXaHEAD app
Time frame: 90 Days
Measure of feasibility
Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality
Time frame: Baseline
Measure of acceptability
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 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Mia Minen, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAXaHEAD app in people with Headache and Migraine, run by NYU Langone Health 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 2 inclusion and 6 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 11 Jul 2022. 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?
Number of days spent logging headache data as determined by entries into the RELAXaHEAD app (time frame: 90 Days). The study lists 4 primary outcomes in all. 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 11 Jul 2022.