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Completed

NCT Number: NCT04382560

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

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.

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Key information

Conditions

Behavior, Social Autonomic Imbalance Behavior Social Behavior

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Rome, 00185, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Dispositional questionnaire 1

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Heart rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 11, 2020
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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