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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04382560
Enrollment
69
Registered
2020-05-11
Start date
2020-05-02
Completion date
2020-05-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Imbalance, Behavior, Social

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.

Interventions

OTHERDeep 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.

OTHERCompassion 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.

Sponsors

University of Roma La Sapienza
CollaboratorOTHER
King's College London
CollaboratorOTHER
University of Parma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

wait-list control design

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Dispositional questionnaire 1During waking hours for two consecutive days before the intervention/control conditionPerseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.
Dispositional questionnaire 2During waking hours for two consecutive days after the intervention/control conditionEffective coping strategies measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a better outcome.
Dispositional questionnaire 3During waking hours for two consecutive days before the intervention/control conditionMood state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.
Dispositional questionnaire 4During waking hours for two consecutive days before the intervention/control conditionEmotional state measured as score on a Likert scale. Minimum score = 1 Maximum score = 5. Higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Heart rateDuring waking hours for two consecutive days before the intervention/control conditionHeart rate (measured in beats per minute) recorded via a smartphone application
Cardiac vagal modulationDuring waking hours for two consecutive days before the intervention/control conditionRoot mean square of the successive differences (measured in ms) recorded via a smartphone application

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026