Building Resilience During the COVID-19 Pandemic: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GSI-T score (Mini-SCL) ≥63,
- •BRS score <3,
- •fluent German speakers,
- •written informed consent.
排除标准
- •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.)
研究组 & 干预措施
RASMUS Resilience Training
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.
干预措施: RASMUS Resilience Training (Behavioral)
Progressive Muscle Relaxation
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.
干预措施: Progressive Muscle Relaxation (Behavioral)
结局指标
主要结局
Total Change Scores on Resilience Scale for Adults (RSA) among Study Completers
时间窗: Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3)
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
次要结局
- 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))
- Total Change Scores on Brief COPE Inventory (COPE)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))
- Total Change Scores on Insomnia Severity Index (ISI)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))
- Total Change Scores on The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))
- Total Change Scores on Brief Symptom Checklist (BSCL)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))
- Total Change Scores on Fatigue Assessment Scale (FAS)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))
- Total Change Scores on Hospital Anxiety and Depression Scale (HADS)(Baseline (T1), 10 weeks (post treatment) (T2) and 6-months follow-up (T3))