Yoga and MBSR for TTH

Not Applicable

Completed

• Conditions: Tension-Type Headache
• Interventions: Behavioral: Mindfulness-based stress reduction; Behavioral: Iyengar Yoga

• Registration Number: NCT04867967
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-04-30
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based stress reduction	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
Iyengar Yoga Intervention	Iyengar Yoga	8-week yoga class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes

Primary Outcome Measures

Name	Time	Method
Headache Frequency	post-intervention (8 weeks)	Headache Frequency self-reported by a headache diary

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Evang. Kliniken Essen-Mitte; 🇩🇪 Essen, Northrhine-Westphalia, Germany