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Completed

NCT Number: NCT04889508

Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion

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.

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Key information

Conditions

Depressive Symptoms Altruism Anxious Symptoms Behavior Behavioral Symptoms Compassion Depression Empathy Genetic Markers Loneliness Prosocial Behavior Resilience Social Behavior Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social Neuroscience Lab

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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.

Treatment and study plan

Socio-emotional mental training

Behavioral

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.

Mindfulness-based mental training

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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

  1. Change in baseline Dot Probe Task (mediating variable) 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 attention bias toward positive and negative stimuli. Negative and positive attention bias indices will serve as dependent variables.

  2. Change in baseline Scrambled Sentences Task (mediating variable) 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 interpretation bias toward positive and negative stimuli. Negative and positive interpretation bias indices will serve as dependent variables

  3. CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring use of only three emotion regulation strategies

  4. FoC - Fear of Expressing Compassion for Others (explanatory mechanism)

    Time frame: 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

  5. FoC - Fear of Expressing Kindness and Compassion Towards Oneself (explanatory mechanism)

    Time frame: 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

  6. S-SCS - Self-kindness (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring levels of kindness shown towards self

  7. S-SCS - Common Humanity (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring feelings of shared humanity

  8. Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism)

    Time frame: 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.

  9. Stress Assessment Questions

    Time frame: 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

  10. Inclusion of Other in the Self Scale

    Time frame: 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

  11. Frequency and quality of social interaction, and empathic listening

    Time frame: 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

  12. Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring levels of worry

  13. IRI - Personal Distress (explanatory mechanism)

    Time frame: 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

  14. MAIA - Self-Regulation and Body Listening (explanatory mechanisms)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring levels of interoceptive awareness

  15. Cognitive Control and Flexibility Questionnaire (CCFQ) - Cognitive Control over Emotions (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring cognitive control exhibited over emotional material

  16. Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring psychological flexibility

  17. DERS (explanatory mechanism)

    Time frame: 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.

  18. Brief-COPE (explanatory mechanism)

    Time frame: 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

  19. PSS-4

    Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups

    A scale measuring perceived stress

  20. Affect Grid (explanatory mechanism)

    Time frame: 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

  21. Cube of Thoughts (explanatory mechanism)

    Time frame: 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

  22. Interoception (explanatory mechanism)

    Time frame: 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

  23. Engagement (explanatory mechanism)

    Time frame: 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

  24. Social connectedness - Inclusion of Other in Self Scale (explanatory mechanism)

    Time frame: 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

  25. Personal Detail Shared (explanatory mechanism)

    Time frame: 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

  26. Loneliness (explanatory mechanism)

    Time frame: 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

  27. Change from baseline Inflammation Marker levels at 10 weeks

    Time frame: 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

  28. Change from baseline Polyepigenetic risk scores at 10 weeks

    Time frame: 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

  29. Belonging to COVID-19 biological risk group

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  30. Belonging to COVID-19 professional risk group

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  31. Positive test result for COVID-19

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  32. Presence of COVID-19 symptoms

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  33. Hospitalization due to COVID-19

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  34. Duration of hospitalization due to COVID-19 (in weeks)

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Number of weeks

  35. History of or current presence of long-covid symptoms

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    Yes or No

  36. Status of COVID-19 vaccination

    Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints

    received none, first or both doses

  37. Perception of benefits of COVID-19 vaccination

    Time frame: 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

  38. Willing to receive COVID-19 vaccination

    Time frame: 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

Other outcomes

  1. TAS-20 (pre-screening)

    Time frame: 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

  2. PHQ-9 (pre-screening)

    Time frame: 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

  3. GAD-7 (pre-screening)

    Time frame: 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

  4. Standardized Assessment of Personality - Abbreviated Scale (pre-screening)

    Time frame: Assessed prior to the intervention, only once, to evaluate presence of personality disorders

    A self-report scale used to screen personality disorders

  5. Composite International Diagnostic Screener CID-S (pre-screening)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Max Planck Social Neuroscience Lab

Other

Collaborators

  • Charite University, Berlin, Germany
  • Humboldt-Universität zu Berlin
  • Max-Planck-Institute of Psychiatry

Registry information

Official study title

Investigating the Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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