RELAXaHEAD for Headache Patients (Phase II)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
Compared with
- Monitored Usual Care (MUC)
Results by group
Number of Patients Enrolled in the Study
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 24 Participants | 24 | |
| Monitored Usual Care (MUC) | 24 Participants | 24 |
RELAX
Monitored Usual Care (MUC)
Daily Diary Satisfaction Scores
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 4.2 score on a scale | 0.6 (Standard Deviation) | 24 |
| Monitored Usual Care (MUC) | 4.2 score on a scale | 0.3 (Standard Deviation) | 24 |
RELAX
Monitored Usual Care (MUC)
Daily Diary Satisfaction Scores
Week 1
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 4.4 score on a scale | 0.6 (Standard Deviation) | 23 |
| Monitored Usual Care (MUC) | 4.2 score on a scale | 0.6 (Standard Deviation) | 23 |
RELAX
Monitored Usual Care (MUC)
Daily Diary Satisfaction Scores
Month 1
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.7 score on a scale | 1.1 (Standard Deviation) | 18 |
| Monitored Usual Care (MUC) | 3.4 score on a scale | 1.1 (Standard Deviation) | 19 |
RELAX
Monitored Usual Care (MUC)
Daily Diary Satisfaction Scores
Month 2
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.9 score on a scale | 0.9 (Standard Deviation) | 17 |
| Monitored Usual Care (MUC) | 3.4 score on a scale | 1 (Standard Deviation) | 20 |
RELAX
Monitored Usual Care (MUC)
Daily Diary Satisfaction Scores
Month 3
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.6 score on a scale | 1.1 (Standard Deviation) | 19 |
| Monitored Usual Care (MUC) | 3.4 score on a scale | 0.9 (Standard Deviation) | 19 |
RELAX
Monitored Usual Care (MUC)
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.7 score on a scale | 0.7 (Standard Deviation) | 24 |
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Week 1
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 4 score on a scale | 0.7 (Standard Deviation) | 23 |
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 1
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.5 score on a scale | 1.2 (Standard Deviation) | 20 |
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 2
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.5 score on a scale | 1.1 (Standard Deviation) | 13 |
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 3
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 3.9 score on a scale | 1.1 (Standard Deviation) | 14 |
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
Up to Month 3
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 22.1 Days | 27.6 (Standard Deviation) | 19 |
Number of Days Participants Used Diary
Up to Month 3
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| RELAX | 54.58 Days | 31.88 (Standard Deviation) | 24 |
| Monitored Usual Care (MUC) | 62.08 Days | 27.27 (Standard Deviation) | 24 |
RELAX
Monitored Usual Care (MUC)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| RELAX | 24 | 0 (0.0%) | 0 |
| Monitored Usual Care (MUC) | 24 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Patients Enrolled in the Study
Baseline
FeasibilityDaily Diary Satisfaction Scores
Baseline
Quality of life (reported by participants)Daily Diary Satisfaction Scores
Week 1
Quality of life (reported by participants)Daily Diary Satisfaction Scores
Month 1
Quality of life (reported by participants)Daily Diary Satisfaction Scores
Month 2
Quality of life (reported by participants)Daily Diary Satisfaction Scores
Month 3
Quality of life (reported by participants)Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Baseline
Quality of life (reported by participants)Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Week 1
Quality of life (reported by participants)Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 1
Quality of life (reported by participants)Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 2
Quality of life (reported by participants)Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Month 3
Quality of life (reported by participants)Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
Up to Month 3
FeasibilityNumber of Days Participants Used Diary
Up to Month 3
Feasibility
Who could take part
MS (type not specified) · 18 to 80
Inclusion Criteria: * Age 18-80 years (age 18-65 in urgent care); * Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria; * Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month OR; meets chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month. * Scoring > or = 15 on the ISI. Exclusion Criteria: * Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy 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 file materials; * Not having a smartphone.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Jun 2022
Main results due
Dec 2022
Finished
Jun 2023
Results posted
Jan 2024
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