NCT04743492

Brief Summary

The purpose of this study is to investigate how pain resilience (as a personality characteristic or a strength) moderate the efficacy of treatment for patients with migraine. The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with the Migraine Disability Assessment Test, MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

February 3, 2021

Last Update Submit

March 11, 2024

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

  • level of disability

    Measured with the Migraine Disability Assessment Test (MIDAS). The total score ranges from 0 to 21 or more. Higher score indicates more disabilities related to migraine. Score over 21 indicates severe disability.

    8 weeks

  • severity of pain

    Self-reported pain scores range from 0 to 10, with 0 meaning no pain at all, and 10 meaning extreme pain. Scoring over 7 indicates severe pain.

    8 weeks

Secondary Outcomes (1)

  • heart rate variability

    8 weeks

Study Arms (4)

CBT group

EXPERIMENTAL

cognitive behavioral therapy (CBT)+routine medical care

Behavioral: cognitive behavioral therapy

exercise therapy group

EXPERIMENTAL

physiotherapy-exercise therapy+routine medical care

Behavioral: cognitive behavioral therapy

breathe training group

EXPERIMENTAL

using biofeedback devices to train breathing speed+routine medical care

Behavioral: cognitive behavioral therapy

usual care

NO INTERVENTION

accepting only routine medical care

Interventions

cognitive behavioral therapyBEHAVIORAL

cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.

CBT groupbreathe training groupexercise therapy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with migraine

You may not qualify if:

  • uncontrolled hypertension
  • coronary artery disease
  • arrhythmia
  • secondary headache(except for medication overuse headache)a
  • age under 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Chang-hua, 500, Taiwan

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ling-Jun Liu, MSc

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

April 16, 2021

Primary Completion

February 28, 2024

Study Completion

May 1, 2024

Last Updated

March 12, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)