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

NCT05802875 | Unknown

• 1 other identifier: Building resilience
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; COVID-19; Distress, Emotional

Keywords

Resilience; MRI

Outcome Measures

Primary Outcomes (1)

• Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers

  RSA is a multifactorial resilience questionnaire, which measures key factors contributing to high resilience, namely family support and cohesion, external support systems, and dispositional attitudes and behaviors. The following areas are investigated: perception of self, planned future, social competence, structural style, family cohesion, and social resources. It consists of 33 items which are to answer on the 7-point response scale

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

Secondary Outcomes (11)

• Total Change Scores on World Health Organization Quality of Life (WHOQOL BREF)

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

• Total Change Scores on Affective Style Questionnaire (ASQ)

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

• Total Change Scores on Self-Compassion Scale (SCS-D)

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

• Total Change Scores on Mindful Attention and Awareness Scale (MAAS)

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

• Total Change Scores on Perceived Stress Scale (PSS-10)

  Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)

Other Outcomes (3)

• Mini International Neuropsychiatric Interview (M.I.N.I.)

  Screening (T1)

• The Brief Resilience Scale (BRS)

  Screening (T1)

• Mini Symptom Check List (Mini-SCL)

  Screening (T1)

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

Progressive Muscle Relaxation

ACTIVE COMPARATOR

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.

Behavioral: Progressive Muscle Relaxation

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

Progressive Muscle Relaxation BEHAVIORAL

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.

Progressive Muscle Relaxation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GSI-T score (Mini-SCL) ≥63,
• BRS score \<3,
• fluent German speakers,
• written informed consent.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Links

• Project Website

MeSH Terms

Conditions

COVID-19

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alex Hofer, Dr.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Hofer, Dr.

CONTACT

+4351250423669; a.hofer@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: March 21, 2023
• First Posted: April 7, 2023
• Study Start: April 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2026
• Last Updated: April 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)