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Yoga and MBSR for TTH

Primary Purpose

Tension-Type Headache

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Iyengar Yoga
Mindfulness-based stress reduction
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tension-Type Headache focused on measuring Tension-Type Headache, Yoga, Mindfulness-based stress reduction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evang. Kliniken Essen-MitteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Iyengar Yoga Intervention

Mindfulness-based stress reduction

Waitlist control

Arm Description

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

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

Waitlist control, ususal care

Outcomes

Primary Outcome Measures

Headache Frequency
Headache Frequency self-reported by a headache diary

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2021
Last Updated
April 29, 2021
Sponsor
Universität Duisburg-Essen
Collaborators
Eden Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT04867967
Brief Title
Yoga and MBSR for TTH
Official Title
Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Eden Stiftung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary study objectives 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Tension-Type Headache, Yoga, Mindfulness-based stress reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iyengar Yoga Intervention
Arm Type
Experimental
Arm Description
8-week yoga class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Arm Title
Mindfulness-based stress reduction
Arm Type
Active Comparator
Arm Description
8-week MBSR class; once weekly; 90 minutes Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Waitlist control, ususal care
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Intervention Description
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
Intervention Name(s)
Mindfulness-based stress reduction
Intervention Description
Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
Primary Outcome Measure Information:
Title
Headache Frequency
Description
Headache Frequency self-reported by a headache diary
Time Frame
post-intervention (8 weeks)
Secondary Outcome Measure Information:
Title
Headache Frequency
Description
Headache Frequency self-reported by a headache diary
Time Frame
follow-up (20 weeks)
Title
Duration of headache episodes
Description
Duration of headache episodes self-reported by a headache diary
Time Frame
post-intervention (8 weeks)
Title
Duration of headache episodes
Description
Duration of headache episodes self-reported by a headache diary
Time Frame
follow-up (20 weeks)
Title
Pain Intensity
Description
Numeric rating scale
Time Frame
post-intervention (8 weeks)
Title
Pain Intensity
Description
Numeric rating scale (NRS)
Time Frame
follow-up (20 weeks)
Title
Pain medication use
Description
Pain medication use self-reported by a headache diary
Time Frame
post-intervention (8 weeks)
Title
Pain medication use
Description
Pain medication use self-reported by a headache diary
Time Frame
follow-up (20 weeks)
Title
Headache related disability
Description
Headche Impact Test 6 (HIT-6)
Time Frame
post-intervention (8 weeks)
Title
Headache related disability
Description
Headche Impact Test 6 (HIT-6)
Time Frame
follow-up (20 weeks)
Title
Health-related quality of life
Description
SF-36 questionaire
Time Frame
post-intervention (8 weeks)
Title
Health-related quality of life
Description
SF-36 questionaire
Time Frame
follow-up (20 weeks)
Title
Anxiety
Description
Depression and Anxiety scale (DAAS)
Time Frame
post-intervention (8 weeks)
Title
Anxiety
Description
Depression and Anxiety scale (DAAS)
Time Frame
follow-up (20 weeks)
Title
Stress
Description
Depression and Anxiety scale (DAAS)
Time Frame
post-intervention (8 weeks)
Title
Stress
Description
Depression and Anxiety scale (DAAS)
Time Frame
follow-up (20 weeks)
Title
Pain catastrophizing
Description
Pain catastrophizing scale (PCS)
Time Frame
post-intervention (8 weeks)
Title
Pain catastrophizing
Description
Pain catastrophizing scale (PCS)
Time Frame
follow-up (20 weeks)
Title
Pain acceptance
Description
Chronic pain acceptance questionaire (CPAQ)
Time Frame
post-intervention (8 weeks)
Title
Pain acceptance
Description
Chronic pain acceptance questionaire (CPAQ)
Time Frame
follow-up (20 weeks)
Title
Mindfulness
Description
Mindfulness Attention and Awerness scale (MAAS)
Time Frame
post-intervention (8 weeks)
Title
Mindfulness
Description
Mindfulness Attention and Awerness scale (MAAS)
Time Frame
follow-up (20 weeks)
Title
Body Awareness
Description
Body Awareness questionaire (BAQ)
Time Frame
post-intervention (8 weeks)
Title
Body Awareness
Description
Body Awareness questionaire (BAQ)
Time Frame
follow-up (20 weeks)
Title
Safety
Description
Adverse events
Time Frame
post-intervention (8 weeks)
Title
Safety
Description
Adverse events
Time Frame
follow-up (20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Anheyer, MA & BSc
Phone
+4920117425550
Email
d.anheyer@kem-med.com
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Cramer, PhD
Email
h.cramer@kem-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, MD
Organizational Affiliation
University of Duisburg-Essen, Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Evang. Kliniken Essen-Mitte
City
Essen
State/Province
Northrhine-Westphalia
ZIP/Postal Code
45276
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Anheyer, MA & BSc
Phone
+4920117425550
Email
d.anheyer@kem-med.com
First Name & Middle Initial & Last Name & Degree
Holger Cramer, PhD
Email
h.cramer@kem-med.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Yoga and MBSR for TTH

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