Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229652
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-19
Brief Title:
Stress Management in Depressive Disorder Resilience Training vs Yoga Biological Epigenetic and Brain Correlates
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
The Impact of Stress Management Interventions on Stress Perception Coping Strategies and Residual Symptoms in Depression a Randomized Controlled Trial Investigating Psychological Biological Epigenetic and Brain Correlates
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program RASMUS compared with yoga on stress perception coping strategies depressive symptoms anxiety resilience and quality of life in people diagnosed with major depressive disorder MDD in the short and long term
In addition to psychological factors biological parameters will be examined to define biomarkers involved in stress response In the optional neuroimaging part the effects of the planned interventions on the structure metabolism and function of the brain will be investigated The epigenetic part which is also optional will examine the effects of the planned interventions on the histone modifications
In addition to psychological factors biological parameters will be examined to define biomarkers involved in stress response In the optional neuroimaging part the effects of the planned interventions on the structure metabolism and function of the brain will be investigated The epigenetic part which is also optional will examine the effects of the planned interventions on the histone modifications
Detailed Description:
The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program RASMUS compared with yoga on stress perception coping strategies depressive symptoms anxiety resilience and quality of life in people diagnosed with major depressive disorder MDD in the short and long term
In addition to psychological factors biological parameters will be examined to define biomarkers involved in stress response In the optional neuroimaging part the effects of the planned interventions on the structure metabolism and function of the brain will be investigated The epigenetic part which is also optional will examine the effects of the planned interventions on the histone modifications A total of 80 participants per study arm are planned for both the MRI and epigenetic studies 20 per gender and per type of intervention
150 outpatients diagnosed with MDD will be randomly assigned to one of two groups an experimental group receiving RASMUS training and a control group receiving body-oriented yoga Both interventions will take place in a group setting of 10-12 participants once a week for one hour over a period of 10 weeks RASMUS aims to build reflect on and strengthen stress management strategies and resilience through mindfulness self-compassion and self-care Through body-oriented yoga participants learn through physical exercises to better control and manage their perception of stress
The planned duration of the clinical trial is 4 years Individual participation in the study will last approximately 8 months and include 4 study visits The first visit will take place after enrolment The second and third visits will take place after the fifth and final intervention The fourth visit will be six months later
In addition to psychological factors biological parameters will be examined to define biomarkers involved in stress response In the optional neuroimaging part the effects of the planned interventions on the structure metabolism and function of the brain will be investigated The epigenetic part which is also optional will examine the effects of the planned interventions on the histone modifications A total of 80 participants per study arm are planned for both the MRI and epigenetic studies 20 per gender and per type of intervention
150 outpatients diagnosed with MDD will be randomly assigned to one of two groups an experimental group receiving RASMUS training and a control group receiving body-oriented yoga Both interventions will take place in a group setting of 10-12 participants once a week for one hour over a period of 10 weeks RASMUS aims to build reflect on and strengthen stress management strategies and resilience through mindfulness self-compassion and self-care Through body-oriented yoga participants learn through physical exercises to better control and manage their perception of stress
The planned duration of the clinical trial is 4 years Individual participation in the study will last approximately 8 months and include 4 study visits The first visit will take place after enrolment The second and third visits will take place after the fifth and final intervention The fourth visit will be six months later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None