Attention Deficit Disorder With HyperactivityNCT03817593
TM Meditation in Children With ADD/ADHD
An observational study of Attention Deficit Disorder With Hyperactivity and Attention-Deficit Disorder in Adolescence, run by Sheba Medical Center.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with limited options for effective pharmacological treatment. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention-Deficit Disorder in Adolescence
- What is being tested?
- Transcendental Meditation (TM)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to 24 May 2022
- Phase
- Observational
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at at the Kadima Zoran School, Israel shall participate in this program.
Who may be able to join
- Children with a confirmed diagnosis of ADHD
Who cannot join
- Comorbidities of Conduct Disorder, ODD, OCD
- Children on psychiatric medications
- Other chronic diseases
About this study
Official title: The Assessment of Transcendental Meditation Training on ADD/ADHD Symptoms of Adolescents.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with limited options for effective pharmacological treatment. Transcendental Meditation (TM) has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. However, the empirical support in favor of meditation for ADHD is limited, and the mechanism by which TM may have an effect on ADD/ADHD is not understood. There is also a conflicted data as to the nature of autonomic dysregulation of ADHD.
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, and considered to be a non-invasive tool to study autonomic nervous system. There is evidence that a non-directive meditation may increase parasympathetic activity and overall HRV. To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
Read more
The aim of this study is to collect the data on ADHD adolescents who will get TM training as a part of out-of-school program, which is offered all children diagnosed with ADD/ADHD, aged 11.5 y-16y, in the community center of Kadima-Zoran, Israel.
The assessment of all of the children participating in this program will be performed with the help of validated questionnaires for diagnosis and follow-up of ADD/ADHD, and HRV monitoring.
In order to perform an assessment in a controlled way, the instruction of TM shall take place in two cycles of 3 months each.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with a prevalence of 5 -10%, and can persist into adulthood (1) It is characterized by a combination of overactive, poorly modulated behavior with marked inattention and may involve physical aggression, which may be associated with a number of structural and functional abnormalities in the central nervous system (2).
Pharmacological treatment is often the treatment of choice; however its effectiveness is limited and often involves considerable side effects (3).
Meditation has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. A systematic review of meditation- based interventions for children with ADHD could not reach definite conclusions regarding their efficacy due to poor methodological quality of the studies (4).
A pilot randomized controlled study published few years ago demonstrated that three months of TM practice resulted in significant improvement of ADHD symptoms (5).
The mechanism by which TM may have an effect on ADD/ADHD is not understood. Furthermore, it is not clear whether TM may have a differential effect on the two subclasses of this condition: inattentive- and hyperactive- type
Individuals with ADHD probably have imbalances in autonomic nervous system activity, which may be associated with impairment of sustained attention (6) and emotional regulation (7,8,9).
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, resulting from dynamic balance of sympathetic and parasympathetic inputs to the heart being a non-invasive tool to study autonomic nervous system, has been proposed to be related to cognitive performance (10) and be a potential marker of stress (11). A lower resting HRV has been associated with greater difficulties in emotional regulation, especially a lack of emotional clarity and impulse control (12), depression and anxiety states (15), while higher levels - with higher cognitive performance, increased emotional regulation and perception of well-being (13, 14).
There is however no agreement as to the nature of autonomic dysregulation of ADHD (9,16,17).
The effect of meditation on autonomic nervous system via changes in heart rate variability has been studied recently. Interestingly, some of the techniques were associated with lower HRV (18), while others - with increased parasympathetic activity and HRV (19). To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
Aims
Primary objective:
To collect the data on ADHD adolescents who will get TM training
Secondary objectives:
- To assess whether improvement of symptoms may be sustained for 3 months after the intervention.
- To assess whether the effect of TM on ADHD symptoms may be correlated with the baseline HRV or ADHD subtypes of the participants.
Participants and Methods
Study design TM classes are going to take place in the facility of Community Center at the Kadima Zoran Community Center for Culture and Sport (as an out-of-school program): a group of TM instructors will provide TM teaching to the adolescents with ADD/ADHD of the Zoran school, with the consent of the teachers and the parents of the children.
Since March 2019, the TM classes will be offered to all children aged 11.5 y-16y, with a confirmed diagnosis of ADD/ADHD, under supervision of the school teachers.
About 50 adolescents out of 60 adolescents, diagnosed with ADHD shall participate in this program.
The assessment and follow-up on these children will be performed by pediatric neurologist and HRV monitoring.
The instruction of TM shall be in two groups (of 20-30 children each). TM training for each group shall be 3 months. The children in both groups shall be followed up for 6 months, and assessed by the same parameters.
Participants:
About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at this school, are expected to participate in this program.
A senior pediatric neurologist will examine the children, confirm the diagnosis, according to the DSM 5 criteria, and shall obtain a written informed consent for the evaluation of the children during this program.
Current pharmacological treatment, ADHD subtype (e.g. inattentive type, combined type or mixed type) and the comorbidities will be documented.
Group 1
Two certified teachers of TM will teach these children according to the following protocol, as previously described by Grosswald et al(20):
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
A group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and then twice a month.
After additional 3 months participants in this group will be examined again, to assess sustainability of the effect.
Group 2 Following the completion of the first 3 months period, the second group will receive TM training as above, and during the first 3 months this will be a reference (control) group.
Data analysis
The data will be analyzed according to the treatment groups. Similarly to the previous study (20) the expected statistical power of 93%will be calculated for comparison of means (Student T-test) .The assumed difference between groups is 0.1 and adopted Standard Deviation within the groups is ±0.1 (20).
Additional observations will be assessed according to the baseline HRV (sympathetic or parasympathetic predominance) and the ADHD subgroups (inattentive or hyperactive predominance), while the two ADHD subgroups and two HRV subgroups will be assessed independently with dichotomous outcomes. In the probable case that the two TM groups (A\&B) shall not be significantly different, both groups may br assessed as one cohort with n=50, assuming dichotomous outcomes. This project may provide a preliminary assessment of the impact of ADHD subtype and of baseline HRV on the differential effect of TM on ADHD symptoms.
- Being tested
- Transcendental Meditation (TM)
- Keywords
- meditation, heart rate variability, ADD, ADHD, children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation (TM)Other
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation (TM) | Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
To ensure the quality of practice, a group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and twice a month for the second and third months.
After additional 3 months participants in this group will be examined again, to assess sustainability of the effect Receives: Other: Transcendental Meditation (TM) | |
| controls | Control group - Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning.
A self-reported scale that assesses overall behavioral and emotional functioning. appropriate behaviors, as well as inappropriate ones. The scale is designed for both parents and teachers, contains both social competency and behavior problem items.
Measured: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Cardiac vagal tone - indexed by heart rate variability (HRV)
HRV refers to changes in normal cardiac interbeat intervals, are under control of the vagus nerve (21), may be a biomarker of psychopathology (22) and of faster recovery from stress (23). HRV is also linked to social and emotional function and can be seen as an objective measure of emotional and social functioning both in healthy and ill population (24).
Measured: The changes in HRV from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Secondary outcomes (2)
Conners 3 questionnaire
Assesses cognitive, behavioral, and emotional problems, with a focus on ADHD and comordbid disorders-providing teacher, parent, and student perspectives
Measured: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Behavior Rating Inventory of Executive Function (BRIEF)
Assesses executive function behaviors in the school and home environments. The questionnaire was developed for parents and teachers of school-age children and is designed to assess the abilities of a broad range of children and adolescents. Tthe BRIEF is useful when working with children who have learning disabilities and attention disorders, traumatic brain injuries, lead exposure, pervasive developmental disorders, depression, and other developmental, neurological, psychiatric, and medical conditions.
Measured: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study startNov 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completion24 May 2022
Why it stopped: Due to COVID epidemics and the multiple lock-downs, we were unable to begin the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817593
- Sponsor's protocol ID
- Sheba-18-5309-DG-CTIL
- Status last verified
- May 2022
- First submitted
- 7 Jan 2019
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Transcendental Meditation Training on ADD/ADHD Symptoms of Adolescents.
- ClinicalTrials.gov ID
- NCT03817593
- Acronym / sponsor ID
- Sheba-18-5309-DG-CTIL
- Keywords
- meditation, heart rate variability, ADD, ADHD, children
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to COVID epidemics and the multiple lock-downs, we were unable to begin the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- 24 May 2022 (actual)
- First posted
- 25 Jan 2019 (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.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with limited options for effective pharmacological treatment. Transcendental Meditation (TM) has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. However, the empirical support in favor of meditation for ADHD is limited, and the mechanism by which TM may have an effect on ADD/ADHD is not understood. There is also a conflicted data as to the nature of autonomic dysregulation of ADHD.
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, and considered to be a non-invasive tool to study autonomic nervous system. There is evidence that a non-directive meditation may increase parasympathetic activity and overall HRV. To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
The aim of this study is to collect the data on ADHD adolescents who will get TM training as a part of out-of-school program, which is offered all children diagnosed with ADD/ADHD, aged 11.5 y-16y, in the community center of Kadima-Zoran, Israel.
The assessment of all of the children participating in this program will be performed with the help of validated questionnaires for diagnosis and follow-up of ADD/ADHD, and HRV monitoring.
In order to perform an assessment in a controlled way, the instruction of TM shall take place in two cycles of 3 months each.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with a prevalence of 5 -10%, and can persist into adulthood (1) It is characterized by a combination of overactive, poorly modulated behavior with marked inattention and may involve physical aggression, which may be associated with a number of structural and functional abnormalities in the central nervous system (2).
Pharmacological treatment is often the treatment of choice; however its effectiveness is limited and often involves considerable side effects (3).
Meditation has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. A systematic review of meditation- based interventions for children with ADHD could not reach definite conclusions regarding their efficacy due to poor methodological quality of the studies (4).
A pilot randomized controlled study published few years ago demonstrated that three months of TM practice resulted in significant improvement of ADHD symptoms (5).
The mechanism by which TM may have an effect on ADD/ADHD is not understood. Furthermore, it is not clear whether TM may have a differential effect on the two subclasses of this condition: inattentive- and hyperactive- type
Individuals with ADHD probably have imbalances in autonomic nervous system activity, which may be associated with impairment of sustained attention (6) and emotional regulation (7,8,9).
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, resulting from dynamic balance of sympathetic and parasympathetic inputs to the heart being a non-invasive tool to study autonomic nervous system, has been proposed to be related to cognitive performance (10) and be a potential marker of stress (11). A lower resting HRV has been associated with greater difficulties in emotional regulation, especially a lack of emotional clarity and impulse control (12), depression and anxiety states (15), while higher levels - with higher cognitive performance, increased emotional regulation and perception of well-being (13, 14).
There is however no agreement as to the nature of autonomic dysregulation of ADHD (9,16,17).
The effect of meditation on autonomic nervous system via changes in heart rate variability has been studied recently. Interestingly, some of the techniques were associated with lower HRV (18), while others - with increased parasympathetic activity and HRV (19). To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
Aims
Primary objective:
To collect the data on ADHD adolescents who will get TM training
Secondary objectives:
- To assess whether improvement of symptoms may be sustained for 3 months after the intervention.
- To assess whether the effect of TM on ADHD symptoms may be correlated with the baseline HRV or ADHD subtypes of the participants.
Participants and Methods
Study design TM classes are going to take place in the facility of Community Center at the Kadima Zoran Community Center for Culture and Sport (as an out-of-school program): a group of TM instructors will provide TM teaching to the adolescents with ADD/ADHD of the Zoran school, with the consent of the teachers and the parents of the children.
Since March 2019, the TM classes will be offered to all children aged 11.5 y-16y, with a confirmed diagnosis of ADD/ADHD, under supervision of the school teachers.
About 50 adolescents out of 60 adolescents, diagnosed with ADHD shall participate in this program.
The assessment and follow-up on these children will be performed by pediatric neurologist and HRV monitoring.
The instruction of TM shall be in two groups (of 20-30 children each). TM training for each group shall be 3 months. The children in both groups shall be followed up for 6 months, and assessed by the same parameters.
Participants:
About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at this school, are expected to participate in this program.
A senior pediatric neurologist will examine the children, confirm the diagnosis, according to the DSM 5 criteria, and shall obtain a written informed consent for the evaluation of the children during this program.
Current pharmacological treatment, ADHD subtype (e.g. inattentive type, combined type or mixed type) and the comorbidities will be documented.
Group 1
Two certified teachers of TM will teach these children according to the following protocol, as previously described by Grosswald et al(20):
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
A group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and then twice a month.
After additional 3 months participants in this group will be examined again, to assess sustainability of the effect.
Group 2 Following the completion of the first 3 months period, the second group will receive TM training as above, and during the first 3 months this will be a reference (control) group.
Data analysis
The data will be analyzed according to the treatment groups. Similarly to the previous study (20) the expected statistical power of 93%will be calculated for comparison of means (Student T-test) .The assumed difference between groups is 0.1 and adopted Standard Deviation within the groups is ±0.1 (20).
Additional observations will be assessed according to the baseline HRV (sympathetic or parasympathetic predominance) and the ADHD subgroups (inattentive or hyperactive predominance), while the two ADHD subgroups and two HRV subgroups will be assessed independently with dichotomous outcomes. In the probable case that the two TM groups (A\&B) shall not be significantly different, both groups may br assessed as one cohort with n=50, assuming dichotomous outcomes. This project may provide a preliminary assessment of the impact of ADHD subtype and of baseline HRV on the differential effect of TM on ADHD symptoms.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation (TM) | – | Other: Transcendental Meditation (TM)Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique. To ensure the quality of practice, a group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and twice a month for the second and third months. After additional 3 months participants in this group will be examined again, to assess sustainability of the effect |
| controls | – | –Control group - Treatment as usual (TAU) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at at the Kadima Zoran School, Israel shall participate in this program.
Key inclusion criteria (1 listed)
- Children with a confirmed diagnosis of ADHD
Key exclusion criteria (3 listed)
- Comorbidities of Conduct Disorder, ODD, OCD
- Children on psychiatric medications
- Other chronic diseases
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 |
|---|---|---|
| Transcendental Meditation (TM)Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique. | Other | Transcendental Meditation (TM) |
Primary outcome
Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning.
Time frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
A self-reported scale that assesses overall behavioral and emotional functioning. appropriate behaviors, as well as inappropriate ones. The scale is designed for both parents and teachers, contains both social competency and behavior problem items.
Cardiac vagal tone - indexed by heart rate variability (HRV)
Time frame: The changes in HRV from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
HRV refers to changes in normal cardiac interbeat intervals, are under control of the vagus nerve (21), may be a biomarker of psychopathology (22) and of faster recovery from stress (23). HRV is also linked to social and emotional function and can be seen as an objective measure of emotional and social functioning both in healthy and ill population (24).
2 secondary outcomes
Conners 3 questionnaire
Time frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity and Attention-Deficit Disorder in Adolescence, run by Sheba Medical Center.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning. (time frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months). 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 31 May 2022.