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Behavioral Intervention

hatha yoga intervention for Headache

N/A

Waitlist Available

Research Sponsored by Matthew Morris

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Eligible participants will have a diagnosis of TTH with or without migraines according to the International Classification for Headache Disorders criteria, be between 13 and 18 years old (inclusive), English-speaking, and willing to be randomized and attend yoga sessions regularly.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This study will determine the efficacy of an 8-week Hatha yoga intervention for adolescents with tension-type headache (TTH) and will assess theoretically-driven mediators of treatment response, including experimental pain sensitivity, chronic stress, and negative cognitions linked to chronic pain.

Eligible Conditions

Headache

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2-week, 4-week, 6-week, post-intervention, 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Disability Inventory - changes in pain-related functional disability over follow-up

Headache Diary - changes in medication use over follow-up

Headache diary - changes in headache frequency over follow-up

+2 more

Secondary study objectives

changes in DHEA reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)

changes in alpha-amylase reactivity to experimental pain task from pre-intervention to immediately following intervention (8 weeks)

changes in conditioned pain modulation from pre-intervention to immediately following intervention (8 weeks)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: hatha yoga interventionExperimental Treatment1 Intervention

Participants randomized to the intervention are asked to attend 8 hatha yoga classes delivered in a group format.

Group II: waitlist controlActive Control1 Intervention

Participants randomized to the waitlist control condition complete assessments while the intervention group completes the yoga intervention. They are given the option to complete 8 hatha yoga classes delivered in group format once the waitlist period is finished.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hatha yoga

2013

Completed Phase 2

~1060

0 / 1Eligibility criteria met