Depressive SymptomsNCT04889508
Investigating Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
A study testing Socio-emotional mental training and Mindfulness-based mental training in people with Depressive Symptoms and Stress, run by Max Planck Social Neuroscience Lab at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Stress, Empathy
- What is being tested?
- Socio-emotional mental training and Mindfulness-based mental training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will have to meet the following inclusion criteria:
- between 18 and 65 years age
- resident of Berlin
- proficiency in German.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the 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.
Read more
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.
- Conditions
- Depressive Symptoms, Stress, Empathy, Compassion, Prosocial Behavior, Anxious Symptoms
- Being tested
- Socio-emotional mental training, Mindfulness-based mental training
- Medical subject headings
- Depression, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-emotional mental trainingBehavioural
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 trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Socio-emotional mental training | Experimental | The socio-emotional intervention will consist of 10 weeks of daily Affect Dyad practice with a partner. Receives: Behavioral: Socio-emotional mental training |
| Mindfulness-based mental training | Experimental | The intervention will consist of 10 weeks of daily individual Breathing Meditation practice. Receives: Behavioral: Mindfulness-based mental training |
| Retest Control Group (Waitlist control) | Other | The retest control group, which is also a waitlist control group, will first not undergo an intervention, but will be tested prior to and after the 10-week period at Pre- and Post-test wherein other groups undergo the interventions.
In a second step, the waitlist control group will then also undergo a 10-week period of socio-emotional intervention.
During the first 10-week intervention period, this group will only be tested serving as a re-test control group. After Post-test, however, they will be given the chance to also enroll in a 10-week socio-emotional mental training with the exact same protocol as the socio-emotional intervention experimental group above.
Both the experimental intervention arm groups will be given the possibility to continue their daily assigned practices (respective socio-emotional and mindfulness-based training exercises) after post-test for the duration of the 10-weeks during which the waitlist control group undergoes the socio-emotional intervention. Receives: Behavioral: Socio-emotional mental training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Beck Depression Inventory (BDI)-II scores at 10 weeks
A scale measuring depression symptoms. Higher scores indicate more depression symptoms.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline State Trait Anxiety Inventory (STAI) scores at 10 weeks
A scale measuring state and trait anxiety symptoms. Higher scores indicate more anxiety symptoms.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Connor Davidson Resilience Scale (CDRISC) score at 10 weeks
A scale measuring psychological resilience. Higher scores indicate more resilience.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline UCLA Loneliness Scale at 10 weeks
A scale measuring loneliness. Higher scores indicate more subjective loneliness.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline State Self Compassion Scale (S-SCS) scores at 10 weeks
A scale measuring compassion towards self. Higher scores indicate more self-compassion.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Perceived Stress Scale (PSS)-10 scores at 10 weeks
A scale measuring perceived stress. Higher scores indicate more perceived stress.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Interpersonal Reactivity Index (IRI) scores at 10 weeks
A scale measuring four aspects of empathy. Higher scores indicate more empathy.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Cortisol Awakening Response at 10 weeks
Cortisol Awakening response.
Measured: 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
Change from baseline Subjective Stress levels at 10 weeks
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).
Measured: 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
Change from baseline Brief Resilience Scale (BRS) scores at 10 weeks
A scale measuring adaptive resilience. Higher scores indicate more resilience.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Difficulties in Emotion Regulation Scale (DERS)-18 scores at 10 weeks
A scale measuring difficulties in use of emotion regulation strategies. Higher scores indicate more difficulties in emotion regulation.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Cognitive Emotion Regulation Questionnaire (CERQ)-18 scores at 10 weeks
A scale measuring use of emotion regulation strategies. Higher scores on a strategy sub scale indicate more use of the emotion regulation strategy.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Fear of Compassion Scale (FoC) scores at 10 weeks
A scale measuring fear of compassion towards self. Higher scores indicate more fear of compassion.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Social Value Orientations (SVO) scores at 10 weeks
A task measuring social value orientations and prosocial behavior. Number of choices will be used as the dependent variable.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Zurich Prosocial Game scores at 10 weeks
A behavioral task assessing levels of prosocial behavior towards others. Number of keys invested in will serve as the dependent variable.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline EmpaToM scores at 10 weeks
A behavioral task assessing empathy and theory of mind. Valence and compassion ratings will serve as the dependent variables.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Social Discounting Task scores at 10 weeks
A behavioral task assessing prosocial behavior and altruism. The degree of discounting will serve as the dependent variable.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 10 weeks
A scale measuring interoception. Higher scores indicate more interoceptive awareness.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Sussex-Oxford Compassion Scale (SOC) scores at 10 weeks
A scale measuring compassion. Higher scores indicate more compassion.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Toronto Alexithymia Scale scores at 10 weeks
A scale measuring Alexithymia. Higher scores indicate more alexithymia.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Trier Social Stress Test (TSST) scores at 10 weeks
A task assessing cortisol response to social stress. Subjective stress and cortisol levels will serve as the dependent variables.
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary outcomes (38)
Change in baseline Dot Probe Task (mediating variable) scores at 10 weeks
A behavioral task assessing attention bias toward positive and negative stimuli. Negative and positive attention bias indices will serve as dependent variables.
Measured: 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
A behavioral task assessing interpretation bias toward positive and negative stimuli. Negative and positive interpretation bias indices will serve as dependent variables
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)
A scale measuring use of only three emotion regulation strategies
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
FoC - Fear of Expressing Compassion for Others (explanatory mechanism)
A scale measuring how much people fear expressing compassion towards others
Measured: 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)
A scale measuring how much people fear expressing compassion towards self
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
S-SCS - Self-kindness (explanatory mechanism)
A scale measuring levels of kindness shown towards self
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
S-SCS - Common Humanity (explanatory mechanism)
A scale measuring feelings of shared humanity
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism)
A scale measuring mindfulness on 5 different sub scales. 1 item with the highest factor loading on each of the 5 subscales.
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Stress Assessment Questions
A scale assessing the occurrence and nature of a stressor
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
Inclusion of Other in the Self Scale
A scale assessing sense of belonging and social connectedness
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
Frequency and quality of social interaction, and empathic listening
A scale assessing quality of social interactions and listening
Measured: 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)
A scale measuring levels of worry
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
IRI - Personal Distress (explanatory mechanism)
A scale measuring levels of personal distress felt when showing empathic concern
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
MAIA - Self-Regulation and Body Listening (explanatory mechanisms)
A scale measuring levels of interoceptive awareness
Measured: 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)
A scale measuring cognitive control exhibited over emotional material
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)
A scale measuring psychological flexibility
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
DERS (explanatory mechanism)
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.
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Brief-COPE (explanatory mechanism)
A scale measuring the frequency of 2 coping strategies used - emotional support and instrumental support
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
PSS-4
A scale measuring perceived stress
Measured: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Affect Grid (explanatory mechanism)
Assessment of emotional state (valence) and arousal
Measured: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Cube of Thoughts (explanatory mechanism)
A scale measuring the temporality and valence of thoughts
Measured: 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)
Assessment of how much bodily sensations are felt
Measured: Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Engagement (explanatory mechanism)
Assessment of how engaged participants felt in the exercise
Measured: 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)
Assessment of how connected participant felt to the dyad partner
Measured: Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, prior to and after the daily exercise
Personal Detail Shared (explanatory mechanism)
Assessment of the level of personal details shared by the participant during exercise
Measured: 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)
Assessment of the level of loneliness by the participant before and after exercise
Measured: 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 Inflammation Marker levels at 10 weeks
Assessment of C-reactive protein (CRP) levels through saliva sample
Measured: Assessed at pre-test (Baseline) and then after 10-week intervention period at post-intervention timepoints
Change from baseline Polyepigenetic risk scores at 10 weeks
Assessment of epigenetic markers through saliva
Measured: 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
Yes or No
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Belonging to COVID-19 professional risk group
Yes or No
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Positive test result for COVID-19
Yes or No
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Presence of COVID-19 symptoms
Yes or No
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Hospitalization due to COVID-19
Yes or No
Measured: 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)
Number of weeks
Measured: 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
Yes or No
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Status of COVID-19 vaccination
received none, first or both doses
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Perception of benefits of COVID-19 vaccination
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
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Willing to receive COVID-19 vaccination
Yes or No. Only in case of no dose received
Measured: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start7 May 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Planck Social Neuroscience Lab
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Humboldt-Universität zu Berlin, Max-Planck-Institute of Psychiatry
- Responsible party
- Sponsor
- Investigators
- Tania Singer, PhD, Principal investigator, Social Neuroscience Lab, Max Planck Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889508
- Sponsor's protocol ID
- CovSocialPhase2
- Status last verified
- Jan 2023
- First submitted
- 6 May 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silveira S, Godara M, Singer T. Boosting Empathy and Compassion Through Mindfulness-Based and Socioemotional Dyadic Practice: Randomized Controlled Trial With App-Delivered Trainings. J Med Internet Res. 2023 Jul 26;25:e45027. doi: 10.2196/45027.
PubMed 37494106Godara 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.
PubMed 34735441
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Differential Effects of Online Mental Training Interventions on Mental Well-being and Social Cohesion
- ClinicalTrials.gov ID
- NCT04889508
- Acronym / sponsor ID
- CovSocialPhase2
- Conditions
- Depressive Symptoms, Stress, Empathy, Compassion, Prosocial Behavior, Anxious Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Max Planck Social Neuroscience LabUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Humboldt-Universität zu Berlin, Max-Planck-Institute of Psychiatry
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Socio-emotional mental training | Experimental | Behavioral: Socio-emotional mental trainingThe socio-emotional intervention will consist of 10 weeks of daily Affect Dyad practice with a partner. |
| Mindfulness-based mental training | Experimental | Behavioral: Mindfulness-based mental trainingThe intervention will consist of 10 weeks of daily individual Breathing Meditation practice. |
| Retest Control Group (Waitlist control) | Other | Behavioral: Socio-emotional mental trainingThe retest control group, which is also a waitlist control group, will first not undergo an intervention, but will be tested prior to and after the 10-week period at Pre- and Post-test wherein other groups undergo the interventions. In a second step, the waitlist control group will then also undergo a 10-week period of socio-emotional intervention. During the first 10-week intervention period, this group will only be tested serving as a re-test control group. After Post-test, however, they will be given the chance to also enroll in a 10-week socio-emotional mental training with the exact same protocol as the socio-emotional intervention experimental group above. Both the experimental intervention arm groups will be given the possibility to continue their daily assigned practices (respective socio-emotional and mindfulness-based training exercises) after post-test for the duration of the 10-weeks during which the waitlist control group undergoes the socio-emotional intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18 and 65 years age
- resident of Berlin
- proficiency in German.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socio-emotional mental trainingCore 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. | Behavioural | Retest Control Group (Waitlist control), Socio-emotional mental training |
| Mindfulness-based mental trainingCore 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). | Behavioural | Mindfulness-based mental training |
Primary outcome
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
38 secondary outcomes
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
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
CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
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
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
S-SCS - Self-kindness (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
S-SCS - Common Humanity (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Five Facet Mindfulness Questionnaire (FFMQ; explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
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
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
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
Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
IRI - Personal Distress (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
MAIA - Self-Regulation and Body Listening (explanatory mechanisms)
Time frame: 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)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
DERS (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Brief-COPE (explanatory mechanism)
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
PSS-4
Time frame: Assessed weekly during the course of 10 weeks of intervention only in intervention groups
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
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
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
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
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
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
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
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
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
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
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
Positive test result for COVID-19
Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Presence of COVID-19 symptoms
Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Hospitalization due to COVID-19
Time frame: 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)
Time frame: 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
Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Status of COVID-19 vaccination
Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
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
Willing to receive COVID-19 vaccination
Time frame: Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 37494106Silveira S, Godara M, Singer T. Boosting Empathy and Compassion Through Mindfulness-Based and Socioemotional Dyadic Practice: Randomized Controlled Trial With App-Delivered Trainings. J Med Internet Res. 2023 Jul 26;25:e45027. doi: 10.2196/45027.
- Derived from this study: PubMed 34735441Godara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Singer, PhD principal investigator
Social Neuroscience Lab, Max Planck Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socio-emotional mental training and Mindfulness-based mental training in people with Depressive Symptoms and Stress, run by Max Planck Social Neuroscience Lab at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.