CompletedNot a drug-phase studyMS (type not specified)NCT05466682

What it found

Results posted, no main test reported

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

GroupValueIntervalNumber analysed
RELAX24 Participants24
Monitored Usual Care (MUC)24 Participants24

RELAX

24

Monitored Usual Care (MUC)

24

Daily Diary Satisfaction Scores

Baseline

GroupValueIntervalNumber analysed
RELAX4.2 score on a scale0.6 (Standard Deviation)24
Monitored Usual Care (MUC)4.2 score on a scale0.3 (Standard Deviation)24

RELAX

4.2

Monitored Usual Care (MUC)

4.2

Daily Diary Satisfaction Scores

Week 1

GroupValueIntervalNumber analysed
RELAX4.4 score on a scale0.6 (Standard Deviation)23
Monitored Usual Care (MUC)4.2 score on a scale0.6 (Standard Deviation)23

RELAX

4.4

Monitored Usual Care (MUC)

4.2

Daily Diary Satisfaction Scores

Month 1

GroupValueIntervalNumber analysed
RELAX3.7 score on a scale1.1 (Standard Deviation)18
Monitored Usual Care (MUC)3.4 score on a scale1.1 (Standard Deviation)19

RELAX

3.7

Monitored Usual Care (MUC)

3.4

Daily Diary Satisfaction Scores

Month 2

GroupValueIntervalNumber analysed
RELAX3.9 score on a scale0.9 (Standard Deviation)17
Monitored Usual Care (MUC)3.4 score on a scale1 (Standard Deviation)20

RELAX

3.9

Monitored Usual Care (MUC)

3.4

Daily Diary Satisfaction Scores

Month 3

GroupValueIntervalNumber analysed
RELAX3.6 score on a scale1.1 (Standard Deviation)19
Monitored Usual Care (MUC)3.4 score on a scale0.9 (Standard Deviation)19

RELAX

3.6

Monitored Usual Care (MUC)

3.4

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

Baseline

GroupValueIntervalNumber analysed
RELAX3.7 score on a scale0.7 (Standard Deviation)24

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

Week 1

GroupValueIntervalNumber analysed
RELAX4 score on a scale0.7 (Standard Deviation)23

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

Month 1

GroupValueIntervalNumber analysed
RELAX3.5 score on a scale1.2 (Standard Deviation)20

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

Month 2

GroupValueIntervalNumber analysed
RELAX3.5 score on a scale1.1 (Standard Deviation)13

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

Month 3

GroupValueIntervalNumber analysed
RELAX3.9 score on a scale1.1 (Standard Deviation)14

Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day

Up to Month 3

GroupValueIntervalNumber analysed
RELAX22.1 Days27.6 (Standard Deviation)19

Number of Days Participants Used Diary

Up to Month 3

GroupValueIntervalNumber analysed
RELAX54.58 Days31.88 (Standard Deviation)24
Monitored Usual Care (MUC)62.08 Days27.27 (Standard Deviation)24

RELAX

54.58

Monitored Usual Care (MUC)

62.08

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
RELAX240 (0.0%)0
Monitored Usual Care (MUC)240 (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

    Feasibility
  • Daily 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

    Feasibility
  • Number 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

    1. Started

      Jun 2022

    2. Main results due

      Dec 2022

    3. Finished

      Jun 2023

    4. Results posted

      Jan 2024

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