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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889508
• Other study ID #: CovSocialPhase2
• Status: Completed
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2023
• Source: Max Planck Social Neuroscience Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxious Symptoms
• Compassion
• Depression
• Depressive Symptoms
• Empathy
• Genetic Markers
• Loneliness
• Prosocial Behavior
• Resilience
• Stress

Intervention

Behavioral:
• Socio-emotional mental training
Core practice: Affect Dyad. In the Affect Dyad (AD), participants perform a 12-minute partner-based exercise which involves contemplating over one difficult situation and one situation which incurred gratitude in the past 24 hours. Both partners take turns speaking about the two situations while the other partner listens in a non-judgmental manner. While the participants elaborate on the situations, they are asked to focus on the bodily experience of the emotions generated during the situation. The goal of the exercise is to enhance coping with difficult emotions, empathic listening, social sharing, acceptance, and gratitude.
• Mindfulness-based mental training
Core practice: Breathing Meditation. In this intervention, participants will practice 12-minute basic attention-based mindfulness meditation such as the Breathing Meditation (BM). BM is a 12-minute individual exercise that requires participants to focus their attention on the sensations of breathing. Participants have to sustain their attention to breath for long stretches of time, and have to return their attention to their breath when their mind wanders. The key focus is on training attention and interoceptive body awareness. Other practices participants will be taught is mindfulness on sounds (here the object of attention is not the breath but sounds in the environment).

Locations

Country	Name	City	State
Germany	Social Neuroscience Lab	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Max Planck Social Neuroscience Lab	Charite University, Berlin, Germany, Humboldt-Universität zu Berlin, Max-Planck-Institute of Psychiatry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TAS-20 (pre-screening)	A scale assessing alexithymia	Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have high levels of alexithymia
Other	PHQ-9 (pre-screening)	A scale assessing depression	Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms
Other	GAD-7 (pre-screening)	A scale assessing generalized anxiety	Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms
Other	Standardized Assessment of Personality - Abbreviated Scale (pre-screening)	A self-report scale used to screen personality disorders	Assessed prior to the intervention, only once, to evaluate presence of personality disorders
Other	Composite International Diagnostic Screener CID-S (pre-screening)	A self-report scale used to screen mental health	Assessed prior to the intervention, only once, to pre-screen out from the study individuals endorsing clinical levels of psychological disorders
Primary	Change from baseline Beck Depression Inventory (BDI)-II scores at 10 weeks	A scale measuring depression symptoms. Higher scores indicate more depression symptoms.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Connor Davidson Resilience Scale (CDRISC) score at 10 weeks	A scale measuring psychological resilience. Higher scores indicate more resilience.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline UCLA Loneliness Scale at 10 weeks	A scale measuring loneliness. Higher scores indicate more subjective loneliness.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Perceived Stress Scale (PSS)-10 scores at 10 weeks	A scale measuring perceived stress. Higher scores indicate more perceived stress.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Interpersonal Reactivity Index (IRI) scores at 10 weeks	A scale measuring four aspects of empathy. Higher scores indicate more empathy.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Cortisol Awakening Response at 10 weeks	Cortisol Awakening response.	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
Primary	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).	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
Primary	Change from baseline Brief Resilience Scale (BRS) scores at 10 weeks	A scale measuring adaptive resilience. Higher scores indicate more resilience.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Multidimensional Assessment of Interoceptive Awareness (MAIA) scores at 10 weeks	A scale measuring interoception. Higher scores indicate more interoceptive awareness.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Sussex-Oxford Compassion Scale (SOC) scores at 10 weeks	A scale measuring compassion. Higher scores indicate more compassion.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	Change from baseline Toronto Alexithymia Scale scores at 10 weeks	A scale measuring Alexithymia. Higher scores indicate more alexithymia.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Primary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	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.	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	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	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)	A scale measuring use of only three emotion regulation strategies	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	FoC - Fear of Expressing Compassion for Others (explanatory mechanism)	A scale measuring how much people fear expressing compassion towards others	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	FoC - Fear of Expressing Kindness and Compassion Towards Oneself (explanatory mechanism)	A scale measuring how much people fear expressing compassion towards self	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	S-SCS - Self-kindness (explanatory mechanism)	A scale measuring levels of kindness shown towards self	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	S-SCS - Common Humanity (explanatory mechanism)	A scale measuring feelings of shared humanity	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	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.	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	Stress Assessment Questions	A scale assessing the occurrence and nature of a stressor	Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
Secondary	Inclusion of Other in the Self Scale	A scale assessing sense of belonging and social connectedness	Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
Secondary	Frequency and quality of social interaction, and empathic listening	A scale assessing quality of social interactions and listening	Assessed weekly during the course of 10 weeks of intervention only in intervention groups in the context of a stressor
Secondary	Penn State Worry Questionnaire (PSWQ)-3 (explanatory mechanism)	A scale measuring levels of worry	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	IRI - Personal Distress (explanatory mechanism)	A scale measuring levels of personal distress felt when showing empathic concern	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	MAIA - Self-Regulation and Body Listening (explanatory mechanisms)	A scale measuring levels of interoceptive awareness	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	Cognitive Control and Flexibility Questionnaire (CCFQ) - Cognitive Control over Emotions (explanatory mechanism)	A scale measuring cognitive control exhibited over emotional material	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	Acceptance and Action Questionnaire (AAQ)-II (explanatory mechanism)	A scale measuring psychological flexibility	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	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.	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	Brief-COPE (explanatory mechanism)	A scale measuring the frequency of 2 coping strategies used - emotional support and instrumental support	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	PSS-4	A scale measuring perceived stress	Assessed weekly during the course of 10 weeks of intervention only in intervention groups
Secondary	Affect Grid (explanatory mechanism)	Assessment of emotional state (valence) and arousal	Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Secondary	Cube of Thoughts (explanatory mechanism)	A scale measuring the temporality and valence of thoughts	Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Secondary	Interoception (explanatory mechanism)	Assessment of how much bodily sensations are felt	Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Secondary	Engagement (explanatory mechanism)	Assessment of how engaged participants felt in the exercise	Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, only once after the daily exercise
Secondary	Social connectedness - Inclusion of Other in Self Scale (explanatory mechanism)	Assessment of how connected participant felt to the dyad partner	Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, prior to and after the daily exercise
Secondary	Personal Detail Shared (explanatory mechanism)	Assessment of the level of personal details shared by the participant during exercise	Assessed for 10 weeks during intervention period, 3 times a week, only in the AD intervention group, only after the daily exercise
Secondary	Loneliness (explanatory mechanism)	Assessment of the level of loneliness by the participant before and after exercise	Assessed for 10 weeks during intervention period, 3 times a week, only in the intervention groups, prior to and after the daily exercise
Secondary	Change from baseline Inflammation Marker levels at 10 weeks	Assessment of C-reactive protein (CRP) levels through saliva sample	Assessed at pre-test (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Change from baseline Polyepigenetic risk scores at 10 weeks	Assessment of epigenetic markers through saliva	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints only in intervention groups
Secondary	Belonging to COVID-19 biological risk group	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Belonging to COVID-19 professional risk group	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Positive test result for COVID-19	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Presence of COVID-19 symptoms	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Hospitalization due to COVID-19	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Duration of hospitalization due to COVID-19 (in weeks)	Number of weeks	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	History of or current presence of long-covid symptoms	Yes or No	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Status of COVID-19 vaccination	received none, first or both doses	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	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	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints
Secondary	Willing to receive COVID-19 vaccination	Yes or No. Only in case of no dose received	Assessed at pre-intervention (Baseline) and then after 10-week intervention period at post-intervention timepoints