Concussion, BrainNCT05399849
Mindfulness Intervention in Young Adults With a Concussion History
A study testing Mindfulness Exercises and Meditations in people with Concussion, Brain and Concussion Post Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Concussion, Brain, Concussion Post Syndrome
- What is being tested?
- Mindfulness Exercises and Meditations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 2 Oct 2022
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young adults aged 18-30
- Concussion history (defined as experiencing a concussive injury within the past five years, but not within the past month)
Who cannot join
- History of moderate and/or severe traumatic brain injury
- Currently under provider care for a concussion/traumatic brain injury
- Health risks (heart conditions, respiratory disorders, and/or neurological disorders) that put them at greater than minimal risk
- Current mindfulness practice
- There will be no exclusion based on self-report sex, race, ethnicity, or mental health history.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-8700
About this study
Official title: Acceptability, Feasibility, Usability, and Effectiveness of a Mindfulness Intervention in Young Adults With a Concussion History: A Pilot Study
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms.
This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.
Read the detailed description
This study is a pilot prospective, feasibility intervention clinical trial. As this is a novel, pilot intervention in the proposed population, the study will utilize an uncontrolled study design where all participants will partake in the six-week, longitudinal mindfulness intervention. All participants will be recruited via the University of North Carolina at Chapel Hill and all data will be collected via the single site. Participants will complete baseline measures for concussion symptoms, perceived stress, and mindfulness. For the six-week intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day. Mindfulness exercises will be completed independently using the LoveYourBrain Foundation Meditation Library, a free, online resource containing traumatic brain injury-focused mindfulness-focused exercises and meditations. Mindfulness-based exercises and meditations to be completed will be chosen by study personnel based on tools utilized in mindfulness-based stress reduction programs that are provided on the LoveYourBrain Meditation Library. Specific mindfulness-based exercises and meditations will include body scan, acceptance, awareness, and breathing. At intervention enrollment participants will be presented with a detailed manual providing them with beginner mindfulness tips and instructions as well as details on the purpose for the intervention. Before beginning the exercises and after being presented the manual, participants will be asked by study personnel if they have any questions or concerns regarding the intervention. Throughout the six-week intervention, study personnel will prompt participants via email and text at the beginning of each week with the specific exercises/meditations to be completed each day for that week. Participants will be prompted via email and text at the end of each week to complete a questionnaire to assess adherence and track concussion symptoms. Participants will have one day to complete the weekly assessment. If it is not completed on that day, study personnel will prompt the participant via email and text for three days. If the assessment is not completed in three days, study personnel will call participants to complete the assessment. At three weeks (halfway through the intervention), study personnel will call participants to complete the weekly assessment and check in on participation. Upon completion of the six-week trial, participants will be prompted via email and text to complete a final assessment including questions regarding adherence, acceptability, feasibility, intervention perceptions, concussion symptoms, perceived stress, and mindfulness. Participants will have one day to complete the final assessment. If they have not completed the final assessment at that time, study personnel will prompt the participant via email and text for three days. If it is not completed after three days, study personnel will call the participant to complete the assessment over the phone.
- Conditions
- Concussion, Brain, Concussion Post Syndrome
- Being tested
- Mindfulness Exercises and Meditations
- Keywords
- Concussion, Mindfulness, Intervention, Perceived Stress
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Exercises and MeditationsBehavioural
Mindfulness exercises will be completed independently using the LoveYourBrain Foundation Meditation Library, a free, online resource containing traumatic brain injury-focused mindfulness-focused exercises and meditations. Mindfulness-based exercises and meditations to be completed will be chosen by study personnel based on tools utilized in mindfulness-based stress reduction programs that are provided on the LoveYourBrain Meditation Library. Specific mindfulness-based exercises and meditations will include body scan, acceptance, awareness, and breathing.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention | Experimental | All participants will be enrolled in the mindfulness intervention arm to complete the six-week mindfulness intervention. Receives: Behavioral: Mindfulness Exercises and Meditations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Acceptability of Intervention (AIM) Total Score
Acceptability will be assessed during the post-intervention follow-up (week 6) assessment using the AIM. The AIM is a four-item validated measure assessing associations with an intervention. It is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive acceptance). The outcome for acceptability will be the AIM total score (range=4-20). The mean AIM total score for all participants will be reported.
Measured: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Mean Feasibility of Intervention (FIM) Total Score
Feasibility will be measured during the post-intervention follow-up (week 6) assessment using the FIM, a four-item validated measure assessing intervention feasibility. The FIM is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive feasibility). The outcome for feasibility will be the FIM total score (range=4-20). The mean FIM total score for all participants will be reported.
Measured: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Secondary outcomes (7)
Mean Days of Mindfulness Exercises/Meditations Completed Per Week
Throughout the intervention participants will be prompted to complete a weekly questionnaire to assess adherence. Subjects will be asked which mindfulness exercises/meditations they completed for that week. Adherence will be assessed at weeks 1, 2, 3, 4, 5, and 6 (post-intervention follow-up). The outcome for adherence will be the number of days of mindfulness exercises/meditations completed per week (range=0-7). The mean number of days of mindfulness exercises/meditations completed per week for all participants will be reported.
Measured: Approximately 7 to 42 days after intervention initiation.
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
Concussion symptoms will be measured using the RPQ, a validated measure which asks participants to report the presence and severity (0-4) of 18 concussion-related symptoms compared with before their concussion. The RPQ has been frequently used in the study population. Concussion symptoms will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). Outcomes for concussion symptoms will include the total symptoms (range=0-18) and total symptom severity (range=0-72) reported from the RPQ. The mean RPQ total symptoms and total symptom severity for all participants will be reported.
Measured: Baseline (pre-intervention, week 0).
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
Concussion symptoms will be measured using the RPQ, a validated measure which asks participants to report the presence and severity (0-4) of 18 concussion-related symptoms compared with before their concussion. The RPQ has been frequently used in the study population. Concussion symptoms will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). Outcomes for concussion symptoms will include the total symptoms (range=0-18) and total symptom severity (range=0-72) reported from the RPQ. The mean RPQ total symptoms and total symptom severity for all participants will be reported.
Measured: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Perceived Stress Scale (PSS-10) Total Score
Perceived stress will be measured using the PSS-10, the most widely used psychological instrument for measuring perceived stress. The PSS-10 is well validated and had been used in connection to mindfulness and in brain injury populations. The PSS-10 consists of 10 questions on a five-point scale (0=never to 4=very often) about how often a participant has felt or thought a certain way relative to their perceived stress in the past month. Final scores will be obtained by reversing responses to the four positively stated items and then summing all 10 scale items (higher scores indicate higher perceived stress). Perceived stress will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for perceived stress will be the PSS-10 total score (range=0-40). The mean PSS-10 total score for all participants will be reported.
Measured: Baseline (pre-intervention, week 0).
Mean Perceived Stress Scale (PSS-10) Total Score
Perceived stress will be measured using the PSS-10, the most widely used psychological instrument for measuring perceived stress. The PSS-10 is well validated and had been used in connection to mindfulness and in brain injury populations. The PSS-10 consists of 10 questions on a five-point scale (0=never to 4=very often) about how often a participant has felt or thought a certain way relative to their perceived stress in the past month. Final scores will be obtained by reversing responses to the four positively stated items and then summing all 10 scale items (higher scores indicate higher perceived stress). Perceived stress will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for perceived stress will be the PSS-10 total score (range=0-40). The mean PSS-10 total score for all participants will be reported.
Measured: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
Mindfulness will be measured using the FFMQ. This widely used, valid survey to measure mindfulness has been researched extensively connected to perceived stress. Participants will be asked 39 questions on a five-point scale (1=never/very rarely true to 5=very often/always true) related to general mindfulness tendencies in daily life. Final scores will be obtained by reversing responses to the 19 reverse scored questions and then summing all 39 items (higher scores indicate greater mindfulness levels). Mindfulness will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for mindfulness will be the FFMQ total score (range=39-195). The mean FFMQ total score for all participants will be reported.
Measured: Baseline (pre-intervention, week 0).
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
Mindfulness will be measured using the FFMQ. This widely used, valid survey to measure mindfulness has been researched extensively connected to perceived stress. Participants will be asked 39 questions on a five-point scale (1=never/very rarely true to 5=very often/always true) related to general mindfulness tendencies in daily life. Final scores will be obtained by reversing responses to the 19 reverse scored questions and then summing all 39 items (higher scores indicate greater mindfulness levels). Mindfulness will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for mindfulness will be the FFMQ total score (range=39-195). The mean FFMQ total score for all participants will be reported.
Measured: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start25 Jul 2022
- Primary completion2 Oct 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine E Callahan, MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399849
- Sponsor's protocol ID
- 22-0732
- Status last verified
- Aug 2022
- First submitted
- 26 May 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility, Usability, and Effectiveness of a Mindfulness Intervention in Young Adults With a Concussion History: A Pilot Study
- ClinicalTrials.gov ID
- NCT05399849
- Acronym / sponsor ID
- 22-0732
- Conditions
- Concussion, Brain, Concussion Post Syndrome
- Keywords
- Concussion, Mindfulness, Intervention, Perceived Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 1 Jun 2022 (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.
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms.
This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.
Detailed description
This study is a pilot prospective, feasibility intervention clinical trial. As this is a novel, pilot intervention in the proposed population, the study will utilize an uncontrolled study design where all participants will partake in the six-week, longitudinal mindfulness intervention. All participants will be recruited via the University of North Carolina at Chapel Hill and all data will be collected via the single site. Participants will complete baseline measures for concussion symptoms, perceived stress, and mindfulness. For the six-week intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day. Mindfulness exercises will be completed independently using the LoveYourBrain Foundation Meditation Library, a free, online resource containing traumatic brain injury-focused mindfulness-focused exercises and meditations. Mindfulness-based exercises and meditations to be completed will be chosen by study personnel based on tools utilized in mindfulness-based stress reduction programs that are provided on the LoveYourBrain Meditation Library. Specific mindfulness-based exercises and meditations will include body scan, acceptance, awareness, and breathing. At intervention enrollment participants will be presented with a detailed manual providing them with beginner mindfulness tips and instructions as well as details on the purpose for the intervention. Before beginning the exercises and after being presented the manual, participants will be asked by study personnel if they have any questions or concerns regarding the intervention. Throughout the six-week intervention, study personnel will prompt participants via email and text at the beginning of each week with the specific exercises/meditations to be completed each day for that week. Participants will be prompted via email and text at the end of each week to complete a questionnaire to assess adherence and track concussion symptoms. Participants will have one day to complete the weekly assessment. If it is not completed on that day, study personnel will prompt the participant via email and text for three days. If the assessment is not completed in three days, study personnel will call participants to complete the assessment. At three weeks (halfway through the intervention), study personnel will call participants to complete the weekly assessment and check in on participation. Upon completion of the six-week trial, participants will be prompted via email and text to complete a final assessment including questions regarding adherence, acceptability, feasibility, intervention perceptions, concussion symptoms, perceived stress, and mindfulness. Participants will have one day to complete the final assessment. If they have not completed the final assessment at that time, study personnel will prompt the participant via email and text for three days. If it is not completed after three days, study personnel will call the participant to complete the assessment over the phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention | Experimental | Behavioral: Mindfulness Exercises and MeditationsAll participants will be enrolled in the mindfulness intervention arm to complete the six-week mindfulness intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young adults aged 18-30
- Concussion history (defined as experiencing a concussive injury within the past five years, but not within the past month)
Key exclusion criteria (5 listed)
- History of moderate and/or severe traumatic brain injury
- Currently under provider care for a concussion/traumatic brain injury
- Health risks (heart conditions, respiratory disorders, and/or neurological disorders) that put them at greater than minimal risk
- Current mindfulness practice
- There will be no exclusion based on self-report sex, race, ethnicity, or mental health history.
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 |
|---|---|---|
| Mindfulness Exercises and MeditationsMindfulness exercises will be completed independently using the LoveYourBrain Foundation Meditation Library, a free, online resource containing traumatic brain injury-focused mindfulness-focused exercises and meditations. Mindfulness-based exercises and meditations to be completed will be chosen by study personnel based on tools utilized in mindfulness-based stress reduction programs that are provided on the LoveYourBrain Meditation Library. Specific mindfulness-based exercises and meditations will include body scan, acceptance, awareness, and breathing. | Behavioural | Mindfulness Intervention |
Primary outcome
Mean Acceptability of Intervention (AIM) Total Score
Time frame: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Acceptability will be assessed during the post-intervention follow-up (week 6) assessment using the AIM. The AIM is a four-item validated measure assessing associations with an intervention. It is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive acceptance). The outcome for acceptability will be the AIM total score (range=4-20). The mean AIM total score for all participants will be reported.
Mean Feasibility of Intervention (FIM) Total Score
Time frame: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Feasibility will be measured during the post-intervention follow-up (week 6) assessment using the FIM, a four-item validated measure assessing intervention feasibility. The FIM is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive feasibility). The outcome for feasibility will be the FIM total score (range=4-20). The mean FIM total score for all participants will be reported.
7 secondary outcomes
Mean Days of Mindfulness Exercises/Meditations Completed Per Week
Time frame: Approximately 7 to 42 days after intervention initiation.
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
Time frame: Baseline (pre-intervention, week 0).
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
Time frame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Perceived Stress Scale (PSS-10) Total Score
Time frame: Baseline (pre-intervention, week 0).
Mean Perceived Stress Scale (PSS-10) Total Score
Time frame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
Time frame: Baseline (pre-intervention, week 0).
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
Time frame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
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 14 Oct 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Christine E Callahan, MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Exercises and Meditations in people with Concussion, Brain and Concussion Post Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 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 14 Oct 2022. 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 United States. 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?
Mean Acceptability of Intervention (AIM) Total Score (time frame: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.). The study lists 2 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 14 Oct 2022.