Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial

Medical University Innsbruck

Status: Enrolling

Conditions: COVID-19; Healthy; Distress, Emotional

Treatments: Behavioral: RASMUS Resilience Training; Behavioral: Progressive Muscle Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT05802875

Building resilience

Details and patient eligibility

About

This clinical trial is to test the efficacy of a Resilience Training (RASMUS) compared to an active control condition (Progressive Muscle Relaxation, PMR) on resilience, psychological distress, and other clinical variables in a group of people out of the general population with clinically relevant psychological symptoms in the context of the COVID-19 pandemic. In addition, this randomized, controlled, parallel-group study will test the efficacy of RASMUS and PMR in relation to brain structure, function, and metabolite levels. In summary, the main study examines the efficacy of two potentially helpful interventions to improve mental health, whereas the imaging 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.

Full description

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 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

Progressive Muscle Relaxation

Active Comparator group

Description:

As a relaxation method with scientifically proven effects, progressive muscle relaxation aims at the conscious, voluntary tension and relaxation of certain muscle groups, which can bring the body into a state of deep relaxation. The application is not only effective in patients with various diseases, but also in healthy people.

Treatment:

Behavioral: Progressive Muscle Relaxation