Clinical trial NCT05802875: Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial
Official title: Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
COVID-19
Distress, Emotional
Keywords: Resilience
MRI
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Secondary outcomes:
measure: Total Change Scores on World Health Organization Quality of Life (WHOQOL BREF)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Affective Style Questionnaire (ASQ)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Self-Compassion Scale (SCS-D)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Mindful Attention and Awareness Scale (MAAS)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Perceived Stress Scale (PSS-10)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Brief COPE Inventory (COPE)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Insomnia Severity Index (ISI)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Brief Symptom Checklist (BSCL)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Fatigue Assessment Scale (FAS)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
measure: Total Change Scores on Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
Other outcomes:
measure: Mini International Neuropsychiatric Interview (M.I.N.I.)
timeFrame: Screening (T1)
measure: The Brief Resilience Scale (BRS)
timeFrame: Screening (T1)
measure: Mini Symptom Check List (Mini-SCL)
timeFrame: Screening (T1)
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Alex Hofer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: