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

NCT04889508 | Completed DMC

• 1 other identifier: CovSocialPhase2
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

The SARS-CoV-2 pandemic, and the associated government-imposed isolationary lockdowns, has led to a mental health crisis on a global scale. Empirical studies have reported a drastic increase in mental health problems, such as depression and anxiety, increased loneliness and feelings of disconnectedness from others, while resilience levels have been negatively affected, indicating an urgent need for intervention. The current study study is embedded in a larger study, the CovSocial study (www.covsocial) which focused in its first phase on evaluating the longitudinal changes in vulnerability, resilience and social cohesion during the SARS-CoV-2 pandemic. The present second phase of this CovSocial study will seek to investigate the efficacy of brief online mindfulness-based and socio-emotional interventions in reducing mental health problems, and enhancing psychological resilience, social competencies and social cohesion. After providing informed consent, participants will be assigned to one of three groups: 1) socio-emotional training group (with Affect Dyads as core exercise), 2) mindfulness-based mental training group (with attention-based mindfulness practices such as Breathing Meditation as core practice), or 3) Retest Control Group (waitlist control).All groups will first undergo a pre-intervention testing phase (pre-test) wherein they will provide a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and behavioral tasks), and biological parameters (saliva samples). During the 10-week intervention period, participants will undergo weekly assessments and daily Ecological Momentary Assessment pre and post the daily exercise practice, using self-report scales and questionnaires delivered through a webapp or mobile app. At the end of the intervention, participants will again undergo an assessment of psychometric measures and biological parameters, same as at pre-intervention time (post-test). In a second portion, the waitlist control group will undergo the socio-emotional intervention and will be tested at post-test II again. Results will reveal the effectiveness of brief online interventions in enhancing mental health and social cohesion outcomes. In addition to examining pre-post intervention-related changes, we will also use the data from the phase 1 of the project to evaluate the impact of trait markers of and the longitudinal changes in vulnerability, resilience and social cohesion on the intervention-related changes in markers of vulnerability, resilience and social cohesion. We will also evaluate the predictive impact of genetic markers of vulnerability, resilience and social cohesion (assessed in phase 1) on intervention-related changes in our variables of interest. The present study will serve as a pilot for future application of scalable, low-cost interventions at a broader level to reduce stress, improve mental health and build resilience in the face of global stressors.

Conditions

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

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (38)

• Change in baseline Dot Probe Task (mediating variable) scores at 10 weeks

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

• Change in baseline Scrambled Sentences Task (mediating variable) scores at 10 weeks

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

• CERQ - Acceptance, Rumination, and Reappraisal (explanatory mechanism)

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

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

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

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

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

Other Outcomes (5)

• TAS-20 (pre-screening)

  Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have high levels of alexithymia

• PHQ-9 (pre-screening)

  Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms

• GAD-7 (pre-screening)

  Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms

Study Arms (3)

Socio-emotional mental training

EXPERIMENTAL

The socio-emotional intervention will consist of 10 weeks of daily Affect Dyad practice with a partner.

Behavioral: Socio-emotional mental training

Mindfulness-based mental training

EXPERIMENTAL

The intervention will consist of 10 weeks of daily individual Breathing Meditation practice.

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.

Behavioral: Socio-emotional mental training

Interventions

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.

Retest Control Group (Waitlist control); Socio-emotional mental training

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).

Mindfulness-based mental training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 65 years age
• resident of Berlin
• proficiency in German.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Max Planck Social Neuroscience Lab: lead
• Charite University, Berlin, Germany: collaborator
• Humboldt-Universität zu Berlin: collaborator
• Max-Planck-Institute of Psychiatry: collaborator

Study Sites (1)

Social Neuroscience Lab

Berlin, Germany

Location

Related Publications (2)

• 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.

  PMID: 37494106 DERIVED

• Godara M, Silveira S, Matthaus H, Heim C, Voelkle M, Hecht M, Binder EB, Singer T. Investigating differential effects of socio-emotional and mindfulness-based online interventions on mental health, resilience and social capacities during the COVID-19 pandemic: The study protocol. PLoS One. 2021 Nov 4;16(11):e0256323. doi: 10.1371/journal.pone.0256323. eCollection 2021.

  PMID: 34735441 DERIVED

MeSH Terms

Conditions

Depression; Altruism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Tania Singer, PhD

  Social Neuroscience Lab, Max Planck Society

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used since both participants and staff need to be aware which condition the participant belongs to in order to be able to attain and provide the appropriate training and practice prior to starting the actual interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 17, 2021
• Study Start: May 7, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

DE (1)