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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое RASMUS Resilience Training
  RASMUS stands for "Resilience through mindfulness, self-compassion and self-care" and is a German-language 10-week group resilience program with one training unit per week. The main content of the RASMUS is based on seven resilience factors, i.e. acceptance, optimism, taking responsibility, solution orientation, future orientation, role clarity, and network orientation including the aspects of mindfulness, self-compassion, and self-care. RASMUS has been tested and certified according to the Ger
• Другое Body-oriented Yoga
  Body-oriented Yoga following the Ashtanga style will be held by certified yoga teacher parallel to the experimental one hour per week 10 times. Each yoga session will start with the proper warming up of the whole body with some stretching exercises (20 min). The main part will last about 30 minutes and consist of dynamic and active yoga sequencing containing sun salutation with a mix of exercises. A relaxation phase with controlled breathing and meditation-elements will finish the class (10 min

Первичные конечные точки

• Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Total Change Scores on the Perceived Stress Scale (PSS-10) among Study Completers [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]

Вторичные конечные точки (6)

• Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers [Срок оценки: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Total Change Scores on the Resilience Scale for Adults (RSA) among Study Completers [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Total Change Scores on the WHO Quality of Life - Brief Version (WHOQOL-BREF) among Study Completers [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Total Change Scores on the Beck Depression Inventory-II (BDI-II) among Study Completers [Срок оценки: 0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Total Change Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) among Study Completers [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]
• Alcohol/ tobacco consumption [Срок оценки: 0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Австрия · 1 центр

• Medical University Innsbruck — Innsbruck

Идентификаторы

NCT: NCT06229652 · Coping with Stress in MDD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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