This clinical trial is to test the efficacy of a Resilience Training (RASMUS) compared toan active control condition (Progressive Muscle Relaxation, PMR) on resilience,psychological distress, and other clinical variables in a group of people out of thegeneral population with clinically relevant psychological symptoms in the context of theCOVID-19 pandemic. In addition, this randomized, controlled, parallel-group study willtest the efficacy of RASMUS and PMR in relation to brain structure, function, andmetabolite levels. In summary, the main study examines the efficacy of two potentiallyhelpful interventions to improve mental health, whereas the imaging sub-studyinvestigates the potential effects of these interventions on brain volumetry and corticalthickness, on metabolite levels in stress-related brain regions, on brain responses, aswell as on functional brain connectivity and communication.
Theoretical framework: The world is experiencing the evolving situation associated with
the outbreak of the Corona Virus Disease-2019 (COVID-19), and there is more of need than
ever for stress management and self-care. Several studies pointed out, that the COVID-19
pandemic is associated with highly significant levels of psychological distress that in
many cases would meet the threshold for clinical relevance. Mental resilience is critical
not only to adapt but also to thrive in these unprecedented times. When stress adversity
or trauma strike, resilient people still experience anger, grief and pain, but they are
able to keep functioning - both physically and psychologically. Resilience is a dynamic
process and can potentially be trained.
Objectives: To test the efficacy of a comprehensive training program aimed at increasing
resilience (RASMUS) and an active control condition (PMR) in relation to brain structure,
function, and metabolite levels.
Methods: 192 people from the general population in Austria who suffer from psychological
distress in the context of the COVID-19 pandemic will be randomly assigned to one of two
treatment conditions: RASMUS or PMR. The outcome measurements are performed at the
beginning, after the intervention (short-term effect) and at the end of the 6-month
follow-up (long-term effect). Study assessments will be conducted via telephone and/or
video conferencing platforms, and online questionnaires. RASMUS and PMR will be offered
as (group-) online courses via video conferencing platforms. In addition, 100 study
participants will be recruited for the neuroimaging sub-study (25/ sex/ condition) and
will undergo magnetic resonance imaging (MRI) to investigate brain energy metabolism,
functional connectivity, and brain responses during functional MRI. MRI will be performed
at baseline, after the intervention (short-term effect) and at the end of a 6-month
follow-up (long-term effect).
Innovation: While the main study examines the efficacy of two potentially helpful
interventions to improve mental health, the current sub-study investigates the potential
effects of these interventions on brain volumetry and cortical thickness, on metabolite
levels in stress-related brain regions, on brain responses, as well as on functional
brain connectivity and communication.
Behavioral: 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 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.
Behavioral: Progressive Muscle Relaxation
Progressive Muscle Relaxation is a representative relaxation technique used in a wide
scope of disorders. Developed by the American physician E.Jacobson in the late 1920s, it
is based on the finding that anxiety states are usually accompanied by increased muscle
tension, while in resting states the muscles are relaxed. By applying this technique, an
individual learns how to relax several muscle groups in the body.
In the context of the current project, PMR is chosen as the active control condition
because it is a broadly accepted and easy-to-implement relaxation exercise that can be
offered as a (group) online course and does not include specific contents of RASMUS.
Inclusion Criteria:
- GSI-T score (Mini-SCL) ≥63,
- BRS score <3,
- fluent German speakers,
- written informed consent.
Exclusion Criteria:
- Any psychiatric disorder according to the Diagnostic and Statistical Manual of
Mental Disorders (DSM-5) (verified by Mini International Neuropsychiatric Interview
[M.I.N.I.] 7.0.2), a history of nicotine or caffeine dependence is acceptable,
- currently engaged in any form of regular psychological therapy offered by
psychologists and/or psychiatrists,
- currently engaged in any form of (group) interventions from other disciplines
(social work, pedagogy, coaching, alternative therapy etc.)
Medical University Innsbruck
Innsbruck, Tirol, Austria
Investigator: Alex Hofer, MD
Contact: +4351250423669
a.hofer@i-med.ac.at
Alex Hofer, Dr.
+4351250423669
a.hofer@i-med.ac.at
Nataliia Maronchuk, MSc.
+4351250482544
nataliia.maronchuk@i-med.ac.at
Alex Hofer, Dr., Principal Investigator
Medical University Innsbruck