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

NCT06229652 | Not Yet Recruiting

• 1 other identifier: Coping with Stress in MDD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Stress management; Coping; Resilience; Yoga

Outcome Measures

Primary Outcomes (2)

• Total Change Scores on the Stress Processing Questionnaire (SVF-ak) among Study Completers

  Stress perception and stress processing modes in the sense of state characteristics will be assessed with the Stress Processing Questionnaire (SVF-ak) (Janke \& Erdmann, 1997; Janke et al., 1985; Kühn, 1986). The SVF-ak retrospectively asks about the stress processing methods used during a previous stress phase/period. The short version of this instrument which will be used in this study consists of 42 questions for the assessment of the extent to which the 19 processing strategies of the SVF - supplemented by the subtest helplessness - were used in certain stressful situations. Subjects indicate on a 4-point scale ranging from 0 (in no case) to 3 (for sure/ with certainty), how often the thought formulated in the item "went through their mind in the previous situation".

  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

  The German version of the Perceived Stress Scale (PSS-10) by Klein et al. (2016) will be used to measure excessive demands and the perception of stress. Subjects indicate on a 5-point Likert scale ranging from null (never) to four (very often) the extent to which situations in their own lives were unpredictable, uncontrollable, and overwhelming in the past month.

  0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)

Secondary Outcomes (6)

• Total Change Scores on the State-Trait-Anxiety Inventory (STAI) among Study Completers

  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

  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

  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

  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

  0 weeks (baseline), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)

Other Outcomes (1)

• Total Change Scores on the Positive and Negative Affect Schedule (PANAS)

  0 weeks (baseline), week 5 (mid), 10 weeks (post treatment) (post1) and 6-months follow-up (post2)

Study Arms (2)

RASMUS Resilience Training

EXPERIMENTAL

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.

Behavioral: RASMUS Resilience Training

Body-oriented Yoga

ACTIVE COMPARATOR

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.

Other: Body-oriented Yoga

Interventions

RASMUS Resilience Training BEHAVIORAL

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 German Prevention Standard. The Central Prevention Test Center has awarded the seal of approval for the areas of exercise, nutrition, stress management/relaxation, and addictive substance consumption. Accordingly, this training program has been certified as a prevention course that is recognized by the German statutory health insurance companies. Furthermore, RASMUS can and is already offered as a (group) online course.

RASMUS Resilience Training

Body-oriented Yoga OTHER

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). Each exercise has different complexity levels of implementation and will be adapted to the performance abilities of each participant.

Body-oriented Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University Innsbruck: lead
• University of Innsbruck: collaborator

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alex Hofer, Dr.

  Medical University Innsbruck

  STUDY DIRECTOR

Central Study Contacts

Fabienne Post, Dr.

CONTACT

+4351250482922; fabienne.post@i-med.ac.at

Nataliia Maronchuk, MSc.

CONTACT

+4351250482544; nataliia.maronchuk@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 5, 2024

Record last verified: 2024-01

Locations

AU (1)