NCT05466682

RELAXaHEAD for Headache Patients (Phase II)

Completed NA Results posted Last updated 10 January 2024

What this trial tests

NA trial testing Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) in Migraine in 48 participants. Completed in 19 June 2023.

Timeline

9 June 2022

Primary endpoint
19 December 2022

19 June 2023

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	9 June 2022
Primary completion	19 December 2022
Estimated completion	19 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
• Monitored Usual Care (MUC)

Conditions studied

• Migraine — all drugs for Migraine →
• Headache — all drugs for Headache →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Insomnia — all drugs for Insomnia →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 80, any sex, with Migraine or Headache. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Enrolled in the Study Primary · Baseline

Measure of feasibility.

Group	Value	95% CI
RELAX	24
Monitored Usual Care (MUC)	24

Daily Diary Satisfaction Scores Primary · Baseline

5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.

Group	Value	95% CI
RELAX	4.2	± 0.6
Monitored Usual Care (MUC)	4.2	± 0.3

Daily Diary Satisfaction Scores Primary · Week 1

5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.

Group	Value	95% CI
RELAX	4.4	± 0.6
Monitored Usual Care (MUC)	4.2	± 0.6

Daily Diary Satisfaction Scores Primary · Month 1

5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.

Group	Value	95% CI
RELAX	3.7	± 1.1
Monitored Usual Care (MUC)	3.4	± 1.1

Daily Diary Satisfaction Scores Primary · Month 2

5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.

Group	Value	95% CI
RELAX	3.9	± 0.9
Monitored Usual Care (MUC)	3.4	± 1

Daily Diary Satisfaction Scores Primary · Month 3

5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.

Group	Value	95% CI
RELAX	3.6	± 1.1
Monitored Usual Care (MUC)	3.4	± 0.9

Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants Primary · Baseline

4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction

Group	Value	95% CI
RELAX	3.7	± 0.7

Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants Primary · Week 1

4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction

Group	Value	95% CI
RELAX	4	± 0.7

Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants Primary · Month 1

4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction

Group	Value	95% CI
RELAX	3.5	± 1.2

Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants Primary · Month 2

4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction

Group	Value	95% CI
RELAX	3.5	± 1.1

Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants Primary · Month 3

4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction

Group	Value	95% CI
RELAX	3.9	± 1.1

Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day Primary · Up to Month 3

Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.

Group	Value	95% CI
RELAX	22.1	± 27.6

Sponsor's own description

The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. 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. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . 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 migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The association between insomnia and migraine disability and quality of life: a secondary analysis of a randomized controlled trial.
   Minen MT, George A, Bostic R, Fanning K, et al · · 2026 · PMID 41206664 · DOI 10.1093/pm/pnaf149