Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates

Medical University Innsbruck

Status: Not yet enrolling

Conditions: Major Depressive Disorder

Treatments: Other: Body-oriented Yoga; Behavioral: RASMUS Resilience Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06229652

Coping with Stress in MDD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

RASMUS Resilience Training

Experimental group

Description:

RASMUS is a systematic, behavior-oriented group training in which the following methods are used: mindfulness exercises, exercises in self-compassion/guided meditations, knowledge transfer by means of a teaching talk/lecture, working out the topics in individual and small group work, group exercises, group discussion and exchange, train coping strategies: somatic, cognitive, and emotional levels, independent reflection on what has been learned, homework, weekly protocols, transfer to everyday life, questionnaires on resilience factors, mindfulness, and self-compassion for self-control, linking the course topics with one another.

Treatment:

Behavioral: RASMUS Resilience Training

Body-oriented Yoga

Active Comparator group

Description:

The body-oriented yoga classes following the Ashtanga style will run in parallel to the RAMUS resilience group (one-hour, once a week). The yoga instructor will support each participant in the form of verbal and hands-on assistance.

Treatment:

Other: Body-oriented Yoga