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

Max Planck Social Neuroscience Lab

Status: Completed

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

Treatments: Behavioral: Mindfulness-based mental training; Behavioral: Socio-emotional mental training

Study type: Interventional

Funder types: Other

Identifiers

NCT04889508

CovSocialPhase2

Details and patient eligibility

About

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.

Enrollment: 285 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 3 patient groups

Socio-emotional mental training

Experimental group

Description:

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

Treatment:

Behavioral: Socio-emotional mental training

Mindfulness-based mental training

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-based mental training

Retest Control Group (Waitlist control)

Other group

Description:

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.

Treatment:

Behavioral: Socio-emotional mental training