Clinical trial NCT06229652: Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Stress management
Coping
Resilience
Yoga
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: University of Innsbruck
First posted: 2024-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of MDD,
* Outpatient care for at least 3 months,
* Ongoing psychopharmacological treatment,
* Age between 18 and 65 years,
* Knowledge of written and spoken German,
* MADRS score ≤ 34 (moderate severity of symptoms),
* Written informed consent.

Exclusion Criteria:

* Other Axis I psychiatric disorder (organic mental disorders, psychoactive substance use \[excl. caffeine and nicotine abuse\], schizophrenia, bipolar disorder, neurotic disorders \[excl. anxiety disorders\], eating disorders, acute suicidality)
* Severe somatic illnesses,
* Pregnancy/breastfeeding,
* Undertaking regular yoga practice (more than once per week) over the past 3 months,
* Current use of psychotherapy.

Further exclusion criteria for the neuroimaging sub-study:

* History of neurological trauma or trauma to the central nervous system,
* MRI contraindications (claustrophobia, metallic, electrical, magnetic or mechanically driven implants, tattoos on the head or neck or other clinically relevant contraindications)
* Positive drug urine test.

Primary outcomes:
measure: Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Total Change Scores on the Perceived Stress Scale (PSS-10) among Study Completers
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Secondary outcomes:
measure: Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers
timeFrame: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Total Change Scores on the Resilience Scale for Adults (RSA) among Study Completers
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Total Change Scores on the WHO Quality of Life - Brief Version (WHOQOL-BREF) among Study Completers
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Total Change Scores on the Beck Depression Inventory-II (BDI-II) among Study Completers
timeFrame: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Total Change Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) among Study Completers
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
measure: Alcohol/ tobacco consumption
timeFrame: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Other outcomes:
measure: Total Change Scores on the Positive and Negative Affect Schedule (PANAS)
timeFrame: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Alex Hofer, Dr.
role: STUDY_DIRECTOR
References: