Investigating the Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Max Planck Social Neuroscience Lab
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Change from baseline UCLA Loneliness Scale at 10 weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants will have to meet the following inclusion criteria:
- •between 18 and 65 years age
- •resident of Berlin
- •proficiency in German.
Exclusion Criteria
- •Participants would be excluded:
- •if they do not have access to internet or technical equipment necessary
- •if they have an educational background in psychology
- •if they have regular spiritual practice (including yoga practice with meditative component)
- •if they take medication that influences physiological markers
- •if they have participated in stress reduction programs previously
- •if they suffer from a chronic illness or pain, or if they have a history of or current psychiatric diagnosis.
- •Toronto Alexithymia Scale-20 (TAS-20; exclude if score greater than 60)
- •Patient Health Questionnaire-9 (PHQ-9; exclude if scores greater than 19)
- •Generalized Anxiety Disorder-7 (GAD-7; exclude if scores greater than 15)
Outcomes
Primary Outcomes
Change from baseline UCLA Loneliness Scale at 10 weeks
Time Frame: 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
Time Frame: 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 State Trait Anxiety Inventory (STAI) scores at 10 weeks
Time Frame: 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 Social Discounting Task scores at 10 weeks
Time Frame: 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 EmpaToM scores at 10 weeks
Time Frame: 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.
Change from baseline Sussex-Oxford Compassion Scale (SOC) scores at 10 weeks
Time Frame: 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 Difficulties in Emotion Regulation Scale (DERS)-18 scores at 10 weeks
Time Frame: 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 Beck Depression Inventory (BDI)-II scores at 10 weeks
Time Frame: 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 Connor Davidson Resilience Scale (CDRISC) score at 10 weeks
Time Frame: 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 Perceived Stress Scale (PSS)-10 scores at 10 weeks
Time Frame: 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 Brief Resilience Scale (BRS) scores at 10 weeks
Time Frame: 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 Toronto Alexithymia Scale scores at 10 weeks
Time Frame: 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 Interpersonal Reactivity Index (IRI) scores at 10 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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 Cognitive Emotion Regulation Questionnaire (CERQ)-18 scores at 10 weeks
Time Frame: 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 Social Value Orientations (SVO) scores at 10 weeks
Time Frame: 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 Fear of Compassion Scale (FoC) scores at 10 weeks
Time Frame: 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 Zurich Prosocial Game scores at 10 weeks
Time Frame: 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 Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 10 weeks
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
- 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)
- S-SCS - Self-kindness (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- S-SCS - Common Humanity (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- Stress Assessment Questions(Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor)
- CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- FoC - Fear of Expressing Compassion for Others (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- DERS (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- IRI - Personal Distress (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- Presence of COVID-19 symptoms(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- 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)
- MAIA - Self-Regulation and Body Listening (explanatory mechanisms)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- 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)
- Brief-COPE (explanatory mechanism)(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- PSS-4(Assessed weekly during the course of 10 weeks of intervention only in intervention groups)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Belonging to COVID-19 biological risk group(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- Belonging to COVID-19 professional risk group(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- Positive test result for COVID-19(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- Hospitalization due to COVID-19(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- 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)
- Status of COVID-19 vaccination(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- Perception of benefits of COVID-19 vaccination(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)
- Willing to receive COVID-19 vaccination(Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints)