Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic

NCT ID: NCT04382560

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2020-05-31

Brief Summary

The present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the COVID-19 pandemic.

Conditions

Behavior, Social; Autonomic Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

The intervention group will receive a Deep Breathing Training and a Compassion Intervention. Deep Breathing Training and Compassion Intervention will be administered once, on two consecutive days, and will last for 30 minutes.

Group Type: EXPERIMENTAL

Deep Breathing training

Intervention Type: OTHER

The intervention will comprise a psychoeducational part on the theorethical background underlying this technique and a pratical session in which partecipant will be instructed to inhale air with his/her nose and exhale with his/her mouth for a period of 3 seconds of inhalation and 7 seconds of exhalation (i.e., 6 cycles of breaths per minute;). During the session, the participant will be encouraged to put one hand over his/her chest and the other over the abdomen in order to see the difference between normal breathing and deep breathing. To help the subjects in the training, an online pacer will give the rhythm of respiration and will be used as visual feedback.

Compassion focused intervention

Intervention Type: OTHER

The short compassion focused intervention will begin with a short psychoeducation on the evolved nature and difficulties of the human mind, such as tendencies for negativity bias, negative rumination, and self-criticism. Participants will then be offered insights into how humans can work with their 'tricky brains' using body-based and psychological-based practices aimed at increasing a grounding and soothing compassionate attitude towards ourselves and others. In particular, participants will be instructed to pratice a mindfulness technique designed to help them to become more aware of their present moment-to-moment and more compassionate towards their own emotions. They will then be guided to create an image conveying warmth and compassion to them. Lastly, participants will be guided to bring the image to mind and then write write a brief "self-compassionate letter" to themselves from that point of view.

Wait-list control group

The waiting list group will receive the intervention at the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Deep Breathing training

The intervention will comprise a psychoeducational part on the theorethical background underlying this technique and a pratical session in which partecipant will be instructed to inhale air with his/her nose and exhale with his/her mouth for a period of 3 seconds of inhalation and 7 seconds of exhalation (i.e., 6 cycles of breaths per minute;). During the session, the participant will be encouraged to put one hand over his/her chest and the other over the abdomen in order to see the difference between normal breathing and deep breathing. To help the subjects in the training, an online pacer will give the rhythm of respiration and will be used as visual feedback.

Intervention Type: OTHER

Compassion focused intervention

The short compassion focused intervention will begin with a short psychoeducation on the evolved nature and difficulties of the human mind, such as tendencies for negativity bias, negative rumination, and self-criticism. Participants will then be offered insights into how humans can work with their 'tricky brains' using body-based and psychological-based practices aimed at increasing a grounding and soothing compassionate attitude towards ourselves and others. In particular, participants will be instructed to pratice a mindfulness technique designed to help them to become more aware of their present moment-to-moment and more compassionate towards their own emotions. They will then be guided to create an image conveying warmth and compassion to them. Lastly, participants will be guided to bring the image to mind and then write write a brief "self-compassionate letter" to themselves from that point of view.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being healthy
• Previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest

Exclusion Criteria

• Self-reported development of cardiovascular disease since previous assessment
• Use of psychotropic medications or medications affecting the autonomic nervous system

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: lead

Responsible Party

Luca Carnevali

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Rome, , Italy

Countries

Italy

Other Identifiers

ESPCOV1

Identifier Type: -

Identifier Source: org_study_id