Clinical trial NCT04889508: Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
Official title: Investigating the Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Stress
Empathy
Compassion
Prosocial Behavior
Anxious Symptoms
Loneliness
Resilience
Genetic Markers
Lead sponsor: Max Planck Social Neuroscience Lab
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Humboldt-Universität zu Berlin
name: Max-Planck-Institute of Psychiatry
First posted: 2021-05-17
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Beck Depression Inventory (BDI)-II scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline State Trait Anxiety Inventory (STAI) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Connor Davidson Resilience Scale (CDRISC) score at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline UCLA Loneliness Scale at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline State Self Compassion Scale (S-SCS) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Perceived Stress Scale (PSS)-10 scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Interpersonal Reactivity Index (IRI) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Cortisol Awakening Response at 10 weeks
timeFrame: 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
measure: Change from baseline Subjective Stress levels at 10 weeks
timeFrame: 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
measure: Change from baseline Brief Resilience Scale (BRS) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Difficulties in Emotion Regulation Scale (DERS)-18 scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Cognitive Emotion Regulation Questionnaire (CERQ)-18 scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Fear of Compassion Scale (FoC) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Social Value Orientations (SVO) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Zurich Prosocial Game scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline EmpaToM scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Social Discounting Task scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Sussex-Oxford Compassion Scale (SOC) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Toronto Alexithymia Scale scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Trier Social Stress Test (TSST) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary outcomes:
measure: Change in baseline Dot Probe Task (mediating variable) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change in baseline Scrambled Sentences Task (mediating variable) scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: FoC - Fear of Expressing Compassion for Others (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: FoC - Fear of Expressing Kindness and Compassion Towards Oneself (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: S-SCS - Self-kindness (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: S-SCS - Common Humanity (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Stress Assessment Questions
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
measure: Inclusion of Other in the Self Scale
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
measure: Frequency and quality of social interaction, and empathic listening
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
measure: Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: IRI - Personal Distress (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: MAIA - Self-Regulation and Body Listening (explanatory mechanisms)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Cognitive Control and Flexibility Questionnaire (CCFQ) - Cognitive Control over Emotions (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: DERS (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Brief-COPE (explanatory mechanism)
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: PSS-4
timeFrame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
measure: Affect Grid (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
measure: Cube of Thoughts (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
measure: Interoception (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
measure: Engagement (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, only once after the daily exercise
measure: Social connectedness - Inclusion of Other in Self Scale (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, prior to and after the daily exercise
measure: Personal Detail Shared (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, only after the daily exercise
measure: Loneliness (explanatory mechanism)
timeFrame: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
measure: Change from baseline Inflammation Marker levels at 10 weeks
timeFrame: Assessed at pre-test (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Change from baseline Polyepigenetic risk scores at 10 weeks
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints only in intervention groups
measure: Belonging to COVID-19 biological risk group
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Belonging to COVID-19 professional risk group
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Positive test result for COVID-19
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Presence of COVID-19 symptoms
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Hospitalization due to COVID-19
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Duration of hospitalization due to COVID-19 (in weeks)
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: History of or current presence of long-covid symptoms
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Status of COVID-19 vaccination
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Perception of benefits of COVID-19 vaccination
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
measure: Willing to receive COVID-19 vaccination
timeFrame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Other outcomes:
measure: TAS-20 (pre-screening)
timeFrame: Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have high levels of alexithymia
measure: PHQ-9 (pre-screening)
timeFrame: Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms
measure: GAD-7 (pre-screening)
timeFrame: Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms
measure: Standardized Assessment of Personality - Abbreviated Scale (pre-screening)
timeFrame: Assessed prior to the intervention, only once, to evaluate presence of personality disorders
measure: Composite International Diagnostic Screener CID-S (pre-screening)
timeFrame: Assessed prior to the intervention, only once, to pre-screen out from the study individuals endorsing clinical levels of psychological disorders
Locations:
city: Berlin
country: Germany
facility: Social Neuroscience Lab
Study officials:
affiliation: Social Neuroscience Lab, Max Planck Society
name: Tania Singer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Godara M, Silveira S, Matthaus H, Heim C, Voelkle M, Hecht M, Binder EB, Singer T. Investigating differential effects of socio-emotional and mindfulness-based online interventions on mental health, resilience and social capacities during the COVID-19 pandemic: The study protocol. PLoS One. 2021 Nov 4;16(11):e0256323. doi: 10.1371/journal.pone.0256323. eCollection 2021.