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

Sponsor
University of Parma (Other)
Overall Status
Completed
CT.gov ID
NCT04382560
Collaborator
University of Roma La Sapienza (Other), King's College London (Other)
69
1
2
29
72.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Deep Breathing training
  • Other: Compassion focused intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
wait-list control designwait-list control design
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine
Actual Study Start Date :
May 2, 2020
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

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.

No Intervention: Wait-list control group

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

Outcome Measures

Primary Outcome Measures

  1. Dispositional questionnaire 1 [During waking hours for two consecutive days before the intervention/control condition]

    Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.

  2. 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.

  3. 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.

  4. Dispositional questionnaire 3 [During waking hours for two consecutive days before 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.

  5. 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.

  6. Dispositional questionnaire 4 [During waking hours for two consecutive days before 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.

  7. 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

  1. Heart rate [During waking hours for two consecutive days before the intervention/control condition]

    Heart rate (measured in beats per minute) recorded via a smartphone application

  2. 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

  3. Cardiac vagal modulation [During waking hours for two consecutive days before the intervention/control condition]

    Root mean square of the successive differences (measured in ms) recorded via a smartphone application

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sapienza University of Rome Rome Italy 00185

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luca Carnevali, PhD, University of Parma
ClinicalTrials.gov Identifier:
NCT04382560
Other Study ID Numbers:
  • ESPCOV1
First Posted:
May 11, 2020
Last Update Posted:
Apr 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 1, 2021