Yoga and MBSR for TTH

Study Overview
=================
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.

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

Conditions
-----------------
Tension-Type Headache

Intervention / Treatment
-----------------
* Behavioral: Iyengar Yoga
* Behavioral: Mindfulness-based stress reduction


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tension-Type Headache, Yoga, Mindfulness-based stress reduction