NCT06229652Not yet recruiting
Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates
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
Source: ClinicalTrials.gov · Last updated 5 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Jan 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Medical University Innsbruck
- Diseases
- Depression
- NCT number
- NCT06229652
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Apr 2024 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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,
- History of neurological trauma or trauma to the central nervous system,
Other
- 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:
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.