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

NCT ID: NCT04889508

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2022-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Socio-emotional mental training

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

Group Type: EXPERIMENTAL

Socio-emotional mental training

Intervention Type: BEHAVIORAL

Core practice: Affect Dyad. In the Affect Dyad (AD), participants perform a 12-minute partner-based exercise which involves contemplating over one difficult situation and one situation which incurred gratitude in the past 24 hours. Both partners take turns speaking about the two situations while the other partner listens in a non-judgmental manner. While the participants elaborate on the situations, they are asked to focus on the bodily experience of the emotions generated during the situation. The goal of the exercise is to enhance coping with difficult emotions, empathic listening, social sharing, acceptance, and gratitude.

Mindfulness-based mental training

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

Group Type: EXPERIMENTAL

Mindfulness-based mental training

Intervention Type: 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).

Retest Control Group (Waitlist control)

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.

Group Type: OTHER

Socio-emotional mental training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role: collaborator

Max-Planck-Institute of Psychiatry

OTHER

Sponsor Role: collaborator

Max Planck Social Neuroscience Lab

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania Singer, PhD

Role: PRINCIPAL_INVESTIGATOR

Social Neuroscience Lab, Max Planck Society

Locations

Social Neuroscience Lab

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37494106 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34735441 (View on PubMed)

Other Identifiers

CovSocialPhase2

Identifier Type: -

Identifier Source: org_study_id