Yoga and MBSR for TTH

NCT04867967 | Completed

• 1 other identifier: 17-7925 BO
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Primary study objectives

1. 1.evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).
2. 2.to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.

Conditions

Tension-Type Headache

Keywords

Tension-Type Headache; Yoga; Mindfulness-based stress reduction

Outcome Measures

Primary Outcomes (1)

• Headache Frequency

  Headache Frequency self-reported by a headache diary

  post-intervention (8 weeks)

Secondary Outcomes (25)

• Headache Frequency

  follow-up (20 weeks)

• Duration of headache episodes

  post-intervention (8 weeks)

• Duration of headache episodes

  follow-up (20 weeks)

• Pain Intensity

  post-intervention (8 weeks)

• Pain Intensity

  follow-up (20 weeks)

Study Arms (3)

Iyengar Yoga Intervention

EXPERIMENTAL

8-week yoga class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Behavioral: Iyengar Yoga

Mindfulness-based stress reduction

ACTIVE COMPARATOR

8-week MBSR class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Behavioral: Mindfulness-based stress reduction

Waitlist control

NO INTERVENTION

Waitlist control, ususal care

Interventions

Iyengar Yoga BEHAVIORAL

Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Iyengar Yoga Intervention

Mindfulness-based stress reduction BEHAVIORAL

Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Mindfulness-based stress reduction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• episodic or chronic tension-type headache according to ICHD-3 definition

You may not qualify if:

• medication induced headache according to ICHD-3 definition
• Cluster-headache according to ICHD-3 definition
• serious chronic systemic or acute physical or mental illness
• Dementia
• Pregnancy
• actual in a yoga or MBSR class

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Eden Stiftung: collaborator

Study Sites (1)

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gustav Dobos, MD

  University of Duisburg-Essen, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. rer. medic

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: February 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)