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

NCT04382560 | Completed

• 1 other identifier: ESPCOV1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Heart rate

  During waking hours for two consecutive days before the intervention/control condition

• Heart rate

  During waking hours for two consecutive days after the intervention/control condition

• Cardiac vagal modulation

  During waking hours for two consecutive days before the intervention/control condition

• Cardiac vagal modulation

  During waking hours for two consecutive days after the intervention/control condition

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Deep Breathing training; Other: Compassion focused intervention

Wait-list control group

NO INTERVENTION

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

Interventions

Deep Breathing training 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.

Intervention group

Compassion focused intervention 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.

Intervention group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Parma: lead
• University of Roma La Sapienza: collaborator
• King's College London: collaborator

Study Sites (1)

Sapienza University of Rome

Rome, 00185, Italy

Location

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: wait-list control design

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 11, 2020
• Study Start: May 2, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)