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

Not Applicable

Completed

• Conditions: Behavior, Social; Autonomic Imbalance
• Interventions: Other: Deep Breathing training; Other: Compassion focused intervention

• Registration Number: NCT04382560
• Lead Sponsor: University of Parma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-02
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-11
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Deep Breathing training	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.
Intervention group	Compassion focused intervention	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.

Primary Outcome Measures

Name	Time	Method
Dispositional questionnaire 1	During waking hours for two consecutive days after the intervention/control condition	Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.
Dispositional questionnaire 3	During waking hours for two consecutive days after the intervention/control condition	Mood state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.
Dispositional questionnaire 2	During waking hours for two consecutive days after the intervention/control condition	Effective coping strategies measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a better outcome.
Dispositional questionnaire 4	During waking hours for two consecutive days after the intervention/control condition	Emotional state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Heart rate	During waking hours for two consecutive days after the intervention/control condition	Heart rate (measured in beats per minute) recorded via a smartphone application
Cardiac vagal modulation	During waking hours for two consecutive days after the intervention/control condition	Root mean square of the successive differences (measured in ms) recorded via a smartphone application

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, Italy