Yoga and MBSR for TTH

Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache

Primary study objectives

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. 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.

Secondary study objectives

Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.

Study Overview

• Status: Recruiting
• Conditions: Tension-Type Headache
• Intervention / Treatment: Behavioral: Iyengar Yoga; Behavioral: Mindfulness-based stress reduction

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dennis Anheyer, MA & BSc; Phone Number: +4920117425550; Email: d.anheyer@kem-med.com
• Study Contact Backup: Name: Holger Cramer, PhD; Email: h.cramer@kem-med.com

Study Locations

• Germany
  • Northrhine-Westphalia
    • Essen, Northrhine-Westphalia, Germany, 45276
      • Recruiting
      • Evang. Kliniken Essen-Mitte
      • Contact: Dennis Anheyer, MA & BSc; Phone Number: +4920117425550; Email: d.anheyer@kem-med.com
      • Contact: Holger Cramer, PhD; Email: h.cramer@kem-med.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iyengar Yoga Intervention; 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; Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Active Comparator: Mindfulness-based stress reduction; 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; Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
No Intervention: Waitlist control; Waitlist control, ususal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Frequency	Headache Frequency self-reported by a headache diary	post-intervention (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Frequency	Headache Frequency self-reported by a headache diary	follow-up (20 weeks)
Duration of headache episodes	Duration of headache episodes self-reported by a headache diary	post-intervention (8 weeks)
Duration of headache episodes	Duration of headache episodes self-reported by a headache diary	follow-up (20 weeks)
Pain Intensity	Numeric rating scale	post-intervention (8 weeks)
Pain Intensity	Numeric rating scale (NRS)	follow-up (20 weeks)
Pain medication use	Pain medication use self-reported by a headache diary	post-intervention (8 weeks)
Pain medication use	Pain medication use self-reported by a headache diary	follow-up (20 weeks)
Headache related disability	Headche Impact Test 6 (HIT-6)	post-intervention (8 weeks)
Headache related disability	Headche Impact Test 6 (HIT-6)	follow-up (20 weeks)
Health-related quality of life	SF-36 questionaire	post-intervention (8 weeks)
Health-related quality of life	SF-36 questionaire	follow-up (20 weeks)
Anxiety	Depression and Anxiety scale (DAAS)	post-intervention (8 weeks)
Anxiety	Depression and Anxiety scale (DAAS)	follow-up (20 weeks)
Stress	Depression and Anxiety scale (DAAS)	post-intervention (8 weeks)
Stress	Depression and Anxiety scale (DAAS)	follow-up (20 weeks)
Pain catastrophizing	Pain catastrophizing scale (PCS)	post-intervention (8 weeks)
Pain catastrophizing	Pain catastrophizing scale (PCS)	follow-up (20 weeks)
Pain acceptance	Chronic pain acceptance questionaire (CPAQ)	post-intervention (8 weeks)
Pain acceptance	Chronic pain acceptance questionaire (CPAQ)	follow-up (20 weeks)
Mindfulness	Mindfulness Attention and Awerness scale (MAAS)	post-intervention (8 weeks)
Mindfulness	Mindfulness Attention and Awerness scale (MAAS)	follow-up (20 weeks)
Body Awareness	Body Awareness questionaire (BAQ)	post-intervention (8 weeks)
Body Awareness	Body Awareness questionaire (BAQ)	follow-up (20 weeks)
Safety	Adverse events	post-intervention (8 weeks)
Safety	Adverse events	follow-up (20 weeks)

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Eden Stiftung
• Investigators: Study Chair: Gustav Dobos, MD, University of Duisburg-Essen, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Yoga; Mindfulness-based stress reduction; Tension-Type Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: 17-7925 BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No