Behavior, SocialNCT04382560
Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic
A study testing Deep Breathing training and Compassion focused intervention in people with Behavior, Social and Autonomic Imbalance, run by University of Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Social, Autonomic Imbalance
- What is being tested?
- Deep Breathing training and Compassion focused intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2020to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Self-reported development of cardiovascular disease since previous assessment
- Use of psychotropic medications or medications affecting the autonomic nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine
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
- Being tested
- Deep Breathing training, Compassion focused intervention
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Breathing trainingOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dispositional questionnaire 1
Perseverative cognition measured as frequency score. Minimum score = 0 Maximum score = 28. Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During waking hours for two consecutive days after the intervention/control condition
Secondary outcomes (4)
Heart rate
Heart rate (measured in beats per minute) recorded via a smartphone application
Measured: During waking hours for two consecutive days before the intervention/control condition
Heart rate
Heart rate (measured in beats per minute) recorded via a smartphone application
Measured: During waking hours for two consecutive days after the intervention/control condition
Cardiac vagal modulation
Root mean square of the successive differences (measured in ms) recorded via a smartphone application
Measured: During waking hours for two consecutive days before the intervention/control condition
Cardiac vagal modulation
Root mean square of the successive differences (measured in ms) recorded via a smartphone application
Measured: During waking hours for two consecutive days after the intervention/control condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start2 May 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- wait-list control design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, King's College London
- Responsible party
- Principal investigator, Luca Carnevali, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382560
- Sponsor's protocol ID
- ESPCOV1
- Status last verified
- Mar 2021
- First submitted
- 5 May 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine
- ClinicalTrials.gov ID
- NCT04382560
- Acronym / sponsor ID
- ESPCOV1
- Conditions
- Behavior, Social, Autonomic Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, King's College London
- Study start
- 2 May 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- wait-list control design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Deep Breathing training, Other: Compassion focused interventionThe 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. |
| Wait-list control group | No intervention | –The waiting list group will receive the intervention at the end of the study. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Self-reported development of cardiovascular disease since previous assessment
- Use of psychotropic medications or medications affecting the autonomic nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Breathing trainingThe 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 | Intervention group |
| Compassion focused interventionThe 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. | Other | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Heart rate
Time frame: During waking hours for two consecutive days before the intervention/control condition
Heart rate
Time frame: During waking hours for two consecutive days after the intervention/control condition
Cardiac vagal modulation
Time frame: During waking hours for two consecutive days before the intervention/control condition
Cardiac vagal modulation
Time frame: During waking hours for two consecutive days after the intervention/control condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Breathing training and Compassion focused intervention in people with Behavior, Social and Autonomic Imbalance, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dispositional questionnaire 1 (time frame: During waking hours for two consecutive days before the intervention/control condition). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.