Anxious Symptoms, Compassion, Depressive Symptoms, Empathy, Genetic Markers, Loneliness, Prosocial Behavior, Resilience, Stress
Conditions
Brief summary
The SARS-CoV-2 pandemic, and the associated government-imposed isolationary lockdowns, has led to a mental health crisis on a global scale. Empirical studies have reported a drastic increase in mental health problems, such as depression and anxiety, increased loneliness and feelings of disconnectedness from others, while resilience levels have been negatively affected, indicating an urgent need for intervention. The current study study is embedded in a larger study, the CovSocial study (www.covsocial) which focused in its first phase on evaluating the longitudinal changes in vulnerability, resilience and social cohesion during the SARS-CoV-2 pandemic. The present second phase of this CovSocial study will seek to investigate the efficacy of brief online mindfulness-based and socio-emotional interventions in reducing mental health problems, and enhancing psychological resilience, social competencies and social cohesion. After providing informed consent, participants will be assigned to one of three groups: 1) socio-emotional training group (with Affect Dyads as core exercise), 2) mindfulness-based mental training group (with attention-based mindfulness practices such as Breathing Meditation as core practice), or 3) Retest Control Group (waitlist control).All groups will first undergo a pre-intervention testing phase (pre-test) wherein they will provide a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and behavioral tasks), and biological parameters (saliva samples). During the 10-week intervention period, participants will undergo weekly assessments and daily Ecological Momentary Assessment pre and post the daily exercise practice, using self-report scales and questionnaires delivered through a webapp or mobile app. At the end of the intervention, participants will again undergo an assessment of psychometric measures and biological parameters, same as at pre-intervention time (post-test). In a second portion, the waitlist control group will undergo the socio-emotional intervention and will be tested at post-test II again. Results will reveal the effectiveness of brief online interventions in enhancing mental health and social cohesion outcomes. In addition to examining pre-post intervention-related changes, we will also use the data from the phase 1 of the project to evaluate the impact of trait markers of and the longitudinal changes in vulnerability, resilience and social cohesion on the intervention-related changes in markers of vulnerability, resilience and social cohesion. We will also evaluate the predictive impact of genetic markers of vulnerability, resilience and social cohesion (assessed in phase 1) on intervention-related changes in our variables of interest. The present study will serve as a pilot for future application of scalable, low-cost interventions at a broader level to reduce stress, improve mental health and build resilience in the face of global stressors.
Interventions
BEHAVIORALSocio-emotional mental training
Core practice: Affect Dyad. In the Affect Dyad (AD), participants perform a 12-minute partner-based exercise which involves contemplating over one difficult situation and one situation which incurred gratitude in the past 24 hours. Both partners take turns speaking about the two situations while the other partner listens in a non-judgmental manner. While the participants elaborate on the situations, they are asked to focus on the bodily experience of the emotions generated during the situation. The goal of the exercise is to enhance coping with difficult emotions, empathic listening, social sharing, acceptance, and gratitude.
BEHAVIORALMindfulness-based mental training
Core practice: Breathing Meditation. In this intervention, participants will practice 12-minute basic attention-based mindfulness meditation such as the Breathing Meditation (BM). BM is a 12-minute individual exercise that requires participants to focus their attention on the sensations of breathing. Participants have to sustain their attention to breath for long stretches of time, and have to return their attention to their breath when their mind wanders. The key focus is on training attention and interoceptive body awareness. Other practices participants will be taught is mindfulness on sounds (here the object of attention is not the breath but sounds in the environment).
Sponsors
Charite University, Berlin, Germany
Humboldt-Universität zu Berlin
Max-Planck-Institute of Psychiatry
Max Planck Social Neuroscience Lab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking will be used since both participants and staff need to be aware which condition the participant belongs to in order to be able to attain and provide the appropriate training and practice prior to starting the actual interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants will have to meet the following inclusion criteria: 1. between 18 and 65 years age 2. resident of Berlin 3. proficiency in German.
Exclusion criteria
Participants would be excluded: 1. if they do not have access to internet or technical equipment necessary 2. if they have an educational background in psychology 3. if they have regular spiritual practice (including yoga practice with meditative component) 4. if they take medication that influences physiological markers 5. if they have participated in stress reduction programs previously 6. if they suffer from a chronic illness or pain, or if they have a history of or current psychiatric diagnosis. 7. Toronto Alexithymia Scale-20 (TAS-20; exclude if score greater than 60) 8. Patient Health Questionnaire-9 (PHQ-9; exclude if scores greater than 19) 9. Generalized Anxiety Disorder-7 (GAD-7; exclude if scores greater than 15) Moreover, participants endorsing suicidality on the PHQ-9 will be excluded. Lastly, participants will be further screened for personality disorder on the Standardized Assessment of Severity of Personality Disorder questionnaire and for endorsement of clinical levels of psychological disorder on CID-S.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Toronto Alexithymia Scale scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring Alexithymia. Higher scores indicate more alexithymia. |
| Change from baseline Sussex-Oxford Compassion Scale (SOC) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring compassion. Higher scores indicate more compassion. |
| Change from baseline Social Discounting Task scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A behavioral task assessing prosocial behavior and altruism. The degree of discounting will serve as the dependent variable. |
| Change from baseline Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring interoception. Higher scores indicate more interoceptive awareness. |
| Change from baseline Trier Social Stress Test (TSST) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A task assessing cortisol response to social stress. Subjective stress and cortisol levels will serve as the dependent variables. |
| Change from baseline Beck Depression Inventory (BDI)-II scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring depression symptoms. Higher scores indicate more depression symptoms. |
| Change from baseline State Trait Anxiety Inventory (STAI) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring state and trait anxiety symptoms. Higher scores indicate more anxiety symptoms. |
| Change from baseline Connor Davidson Resilience Scale (CDRISC) score at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring psychological resilience. Higher scores indicate more resilience. |
| Change from baseline UCLA Loneliness Scale at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring loneliness. Higher scores indicate more subjective loneliness. |
| Change from baseline State Self Compassion Scale (S-SCS) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring compassion towards self. Higher scores indicate more self-compassion. |
| Change from baseline Perceived Stress Scale (PSS)-10 scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring perceived stress. Higher scores indicate more perceived stress. |
| Change from baseline Interpersonal Reactivity Index (IRI) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring four aspects of empathy. Higher scores indicate more empathy. |
| Change from baseline Cortisol Awakening Response at 10 weeks | Assessed at pre-intervention over a period 2 days (Baseline), and then after 10-week intervention period at post-intervention timepoint again for 4 days | Cortisol Awakening response. |
| Change from baseline Subjective Stress levels at 10 weeks | Assessed at pre-intervention over a period 8 days (Baseline), and then after 10-week intervention period at post-intervention timepoint again for 8 days | Assessment of quality of sleep, stressor appraisal, coping with stressor, affective state, valence and temporal orientation of thoughts, perceived emotional control, and interoceptive awareness. Using Ecological Momentary Assessment(EMA). |
| Change from baseline Brief Resilience Scale (BRS) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring adaptive resilience. Higher scores indicate more resilience. |
| Change from baseline Difficulties in Emotion Regulation Scale (DERS)-18 scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring difficulties in use of emotion regulation strategies. Higher scores indicate more difficulties in emotion regulation. |
| Change from baseline Cognitive Emotion Regulation Questionnaire (CERQ)-18 scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring use of emotion regulation strategies. Higher scores on a strategy sub scale indicate more use of the emotion regulation strategy. |
| Change from baseline Fear of Compassion Scale (FoC) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A scale measuring fear of compassion towards self. Higher scores indicate more fear of compassion. |
| Change from baseline Social Value Orientations (SVO) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A task measuring social value orientations and prosocial behavior. Number of choices will be used as the dependent variable. |
| Change from baseline Zurich Prosocial Game scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A behavioral task assessing levels of prosocial behavior towards others. Number of keys invested in will serve as the dependent variable. |
| Change from baseline EmpaToM scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A behavioral task assessing empathy and theory of mind. Valence and compassion ratings will serve as the dependent variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affect Grid (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise | Assessment of emotional state (valence) and arousal |
| Cube of Thoughts (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise | A scale measuring the temporality and valence of thoughts |
| Interoception (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise | Assessment of how much bodily sensations are felt |
| Engagement (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, only once after the daily exercise | Assessment of how engaged participants felt in the exercise |
| Social connectedness - Inclusion of Other in Self Scale (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, prior to and after the daily exercise | Assessment of how connected participant felt to the dyad partner |
| Personal Detail Shared (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, only after the daily exercise | Assessment of the level of personal details shared by the participant during exercise |
| Loneliness (explanatory mechanism) | Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise | Assessment of the level of loneliness by the participant before and after exercise |
| Change from baseline Inflammation Marker levels at 10 weeks | Assessed at pre-test (Baseline) and then after 10-week intervention period at post-intervention timepoints | Assessment of C-reactive protein (CRP) levels through saliva sample |
| Change from baseline Polyepigenetic risk scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints only in intervention groups | Assessment of epigenetic markers through saliva |
| Belonging to COVID-19 biological risk group | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Positive test result for COVID-19 | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Presence of COVID-19 symptoms | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Hospitalization due to COVID-19 | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Duration of hospitalization due to COVID-19 (in weeks) | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Number of weeks |
| History of or current presence of long-covid symptoms | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Perception of benefits of COVID-19 vaccination | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | in case of one or two doses received willingness to receive COVID-19 vaccination (in case of no dose received), and impact of COVID-19 related restrictions and limitations |
| Willing to receive COVID-19 vaccination | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No. Only in case of no dose received |
| Status of COVID-19 vaccination | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | received none, first or both doses |
| Change in baseline Dot Probe Task (mediating variable) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A behavioral task assessing attention bias toward positive and negative stimuli. Negative and positive attention bias indices will serve as dependent variables. |
| Change in baseline Scrambled Sentences Task (mediating variable) scores at 10 weeks | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | A behavioral task assessing interpretation bias toward positive and negative stimuli. Negative and positive interpretation bias indices will serve as dependent variables |
| CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring use of only three emotion regulation strategies |
| FoC - Fear of Expressing Compassion for Others (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring how much people fear expressing compassion towards others |
| FoC - Fear of Expressing Kindness and Compassion Towards Oneself (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring how much people fear expressing compassion towards self |
| S-SCS - Self-kindness (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring levels of kindness shown towards self |
| S-SCS - Common Humanity (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring feelings of shared humanity |
| Belonging to COVID-19 professional risk group | Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints | Yes or No |
| Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring mindfulness on 5 different sub scales. 1 item with the highest factor loading on each of the 5 subscales. |
| Stress Assessment Questions | Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor | A scale assessing the occurrence and nature of a stressor |
| Inclusion of Other in the Self Scale | Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor | A scale assessing sense of belonging and social connectedness |
| Frequency and quality of social interaction, and empathic listening | Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor | A scale assessing quality of social interactions and listening |
| Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring levels of worry |
| IRI - Personal Distress (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring levels of personal distress felt when showing empathic concern |
| MAIA - Self-Regulation and Body Listening (explanatory mechanisms) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring levels of interoceptive awareness |
| Cognitive Control and Flexibility Questionnaire (CCFQ) - Cognitive Control over Emotions (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring cognitive control exhibited over emotional material |
| Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring psychological flexibility |
| DERS (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | 1 item each from the following subscales: Nonacceptance of emotional responses, Difficulty engaging in Goal-directed behavior, Lack of emotional awareness, Limited access to emotion regulation strategies, Lack of emotional clarity. |
| Brief-COPE (explanatory mechanism) | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring the frequency of 2 coping strategies used - emotional support and instrumental support |
| PSS-4 | Assessed weekly during the course of 10 weeks of intervention only in intervention groups | A scale measuring perceived stress |
Other
| Measure | Time frame | Description |
|---|---|---|
| TAS-20 (pre-screening) | Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have high levels of alexithymia | A scale assessing alexithymia |
| Composite International Diagnostic Screener CID-S (pre-screening) | Assessed prior to the intervention, only once, to pre-screen out from the study individuals endorsing clinical levels of psychological disorders | A self-report scale used to screen mental health |
| Standardized Assessment of Personality - Abbreviated Scale (pre-screening) | Assessed prior to the intervention, only once, to evaluate presence of personality disorders | A self-report scale used to screen personality disorders |
| GAD-7 (pre-screening) | Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms | A scale assessing generalized anxiety |
| PHQ-9 (pre-screening) | Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms | A scale assessing depression |
Countries
Germany
Outcome results
None listed