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

Autonomic Imbalance Clinical Trial

Official title:

Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382560
• Other study ID #: ESPCOV1
• Status: Completed
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2021
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Imbalance
• Behavior, Social

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Rome

Sponsors (3)

Lead Sponsor	Collaborator
University of Parma	King's College London, University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dispositional questionnaire 1	Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.	During waking hours for two consecutive days before the intervention/control condition
Primary	Dispositional questionnaire 1	Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.	During waking hours for two consecutive days after the intervention/control condition
Primary	Dispositional questionnaire 2	Effective coping strategies measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a better outcome.	During waking hours for two consecutive days after the intervention/control condition
Primary	Dispositional questionnaire 3	Mood state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.	During waking hours for two consecutive days before the intervention/control condition
Primary	Dispositional questionnaire 3	Mood state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.	During waking hours for two consecutive days after the intervention/control condition
Primary	Dispositional questionnaire 4	Emotional state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.	During waking hours for two consecutive days before the intervention/control condition
Primary	Dispositional questionnaire 4	Emotional state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.	During waking hours for two consecutive days after the intervention/control condition
Secondary	Heart rate	Heart rate (measured in beats per minute) recorded via a smartphone application	During waking hours for two consecutive days before the intervention/control condition
Secondary	Heart rate	Heart rate (measured in beats per minute) recorded via a smartphone application	During waking hours for two consecutive days after the intervention/control condition
Secondary	Cardiac vagal modulation	Root mean square of the successive differences (measured in ms) recorded via a smartphone application	During waking hours for two consecutive days before the intervention/control condition
Secondary	Cardiac vagal modulation	Root mean square of the successive differences (measured in ms) recorded via a smartphone application	During waking hours for two consecutive days after the intervention/control condition