Yoga and MBSR for TTH

NCT ID: NCT04867967

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-12-30

Brief Summary

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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

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Conditions

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Iyengar Yoga

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

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

Waitlist control

Waitlist control, ususal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eden Stiftung

UNKNOWN

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Holger Cramer

PD Dr. rer. medic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav Dobos, MD

Role: STUDY_CHAIR

University of Duisburg-Essen, Faculty of Medicine

Locations

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Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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17-7925 BO

Identifier Type: -

Identifier Source: org_study_id

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