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| Name | Class |
|---|---|
| Ministry of Research, Innovation and Science, Ontario | OTHER |
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Excessive and uncontrollable worry has been associated with deficits in attention control. The Attention Training Technique (ATT; Wells, 1990) is a 12-minute audio recording that was developed to train attention control, so that individuals could learn to shift their attention away from maladaptive cognitive processes such as worry. The technique has shown to be promising at reducing symptoms across a variety of mental disorders (Knowles, Foden, El-Deredy, & Wells, 2016) and is recommended for use in people who suffer from chronic worry. To date, little research has been conducted examining the benefits of using this technique in such a population. The present study aims to examine the immediate and short term effects of weekly ATT practice, compared to a control condition, in a population that suffers from high levels of worry about a variety of topics. About one-hundred participants who suffer from chronic worry will be randomly assigned to listen to the ATT or a control recording, every day for a week. Changes in attention control, worry, and cognitive processes will be examined over the course of the intervention period.
People who suffer from pathological worry report that they worry to an excessive degree and that they find it very difficult to control their worry. Deficits in attention control may help to explain why people who worry pathologically find it difficult to shift their attention away from their worry, and back to the task at hand. The Attention Training Technique (ATT; Wells, 1990) was developed to train attentional control, so that individuals could learn to shift the focus of their attention away from maladaptive cognitive processes such as worry. Despite being recommended for use in populations that suffer from excessive worry, there is a dearth of research examining the effects of ATT in such a population. The study aims to examine the immediate (during the intervention) and short-term (right after finishing the intervention) effects of listening to the ATT, compared to the control recording, on attention, worry, and other cognitive processes. This will be the first study to our knowledge to examine the effects of 1 week of daily ATT practice in a sample of people who suffer from chronic worry, and will provide important information for optimizing the treatment of worry in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Training Technique | Experimental | Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. |
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| Control Condition | Placebo Comparator | Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention Training Technique | Behavioral | The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task. |
| Measure | Description | Time Frame |
|---|---|---|
| Breathing Focus Task -Negative Intrusions | Behavioural measure of attention control over worry. Number of negative thought intrusions reported during the post-worry breathing focus period (i.e. a period of focused breathing after a period of worry). Scores range from 0-12. A greater number means more negative thought intrusions. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Daily Worry Questions | A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry. Only uncontrollability of worry was used (see Data Analysis Plan for rationale). Scores range from 0-6. Higher scores represent greater uncontrollability of worry. | Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Penn State Worry Questionnaire-Past Week | Self-report measure of the degree of worry experienced over the past week. Scores range from 15 to 75. Higher scores indicate higher worry over the past week. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Measure | Description | Time Frame |
|---|---|---|
| UPPS-P | Self-report measure of impulsivity. Scores range from 12 to 48. Greater scores indicate greater negative urgency. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen E Stewart, Bsc | Toronto Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryerson University | Toronto | Ontario | M5B 2K3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990. | ||
| 27129094 | Background | Knowles MM, Foden P, El-Deredy W, Wells A. A Systematic Review of Efficacy of the Attention Training Technique in Clinical and Nonclinical Samples. J Clin Psychol. 2016 Oct;72(10):999-1025. doi: 10.1002/jclp.22312. Epub 2016 Apr 29. | |
| 33872957 |
| Label | URL |
|---|---|
| Lab Website | View source |
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Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.
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Participants were recruited with flyers and online advertisements. Recruitment took place between 2017-2019 at Ryerson University, Toronto, Ontario, Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Training Technique | Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task. |
| FG001 | Control Condition | Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Complete case analysis was used, thus only participants who completed the entire intervention were included in the baseline analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Training Technique | Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breathing Focus Task -Negative Intrusions | Behavioural measure of attention control over worry. Number of negative thought intrusions reported during the post-worry breathing focus period (i.e. a period of focused breathing after a period of worry). Scores range from 0-12. A greater number means more negative thought intrusions. | Participants were only included on this analyses if they had data for all time points. 3 participants were not included (1 from ATT, 2 from control). | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Training Technique | Participants in this arm will listen to the Attention Training Technique. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Attention Training Technique: The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naomi Koerner | Ryerson University | 416-979-5000 | ext. 5521 | naomi.koerner@ryerson.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2021 | Jun 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Baseline outcome measures will be completed at the first visit to the lab. Participants will then engage in a week of reporting on their worry and attention on their own, before coming back to the lab to recomplete the outcome measures. They will then be randomly assigned to the intervention or control condition and will engage in a week of daily listening to the corresponding recording for their condition on their own, while reporting on their worry and attention again during that week. Outcome measures will be completed again at the lab immediately following the intervention.
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| Control Condition | Behavioral | In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions. |
|
| Self-Attention Rating Scale | A daily self-report measure of focus of attention (from internal to externally focused). The scale ranges from 0 to 6. 0 represents entirely externally focused and 6 represents entirely internally focused. | Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period. |
| Attention Network Task (ANT) | Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale | Self-report measure of focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale | Self-report measure of beliefs about the uncontrollability and dangerousness of worry. Scores range from 6-24. Greater scores represent greater negative beliefs about worry. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Attention Control Scale | Self-report measure of attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Dot Probe | Behavioural measure of attentional bias to threat related words, measured in reaction time. A larger positive number indicates a greater bias to threat information while a negative number indicates the participant was faster to respond to neutral information. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Southampton Mindfulness Questionnaire | Self-report measure of mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness. | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
| Derived |
| Stewart KE, Antony MM, Koerner N. A randomized experimental analysis of the attention training technique: Effects on worry and relevant processes in individuals with probable generalized anxiety disorder. Behav Res Ther. 2021 Jun;141:103863. doi: 10.1016/j.brat.2021.103863. Epub 2021 Apr 10. |
| BG001 | Control Condition | Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Penn State Worry Questionnaire | Range: 16-80 Greater scores indicate greater pathological worry | Mean | Standard Deviation | units on a scale |
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| Generalized Anxiety Disorder Questionnaire-IV | Range: 0-12 Greater scores include greater GAD symptom severity | Mean | Standard Deviation | units on a scale |
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| Center for Epidemiologic Studies Depression Scale-Revised | Range: 0- 60 Greater scores represent greater depression symptom severity | Mean | Standard Deviation | units on a scale |
|
| OG001 | Control Condition | Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions. |
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| Primary | Daily Worry Questions | A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry. Only uncontrollability of worry was used (see Data Analysis Plan for rationale). Scores range from 0-6. Higher scores represent greater uncontrollability of worry. | Posted | Mean | Standard Deviation | units on a scale | Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period. |
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| Secondary | Penn State Worry Questionnaire-Past Week | Self-report measure of the degree of worry experienced over the past week. Scores range from 15 to 75. Higher scores indicate higher worry over the past week. | Participants were only included on this analyses if they had data for all time points. 1 participant was not included from the control condition. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Self-Attention Rating Scale | A daily self-report measure of focus of attention (from internal to externally focused). The scale ranges from 0 to 6. 0 represents entirely externally focused and 6 represents entirely internally focused. | Posted | Mean | Standard Deviation | units on a scale | Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period. |
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| Secondary | Attention Network Task (ANT) | Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control. | Participants were only included on this analyses if they had data for all time points. 10 participants were not included (2 from ATT, 8 from control). | Posted | Mean | Standard Deviation | miliseconds | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale | Self-report measure of focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale | Self-report measure of beliefs about the uncontrollability and dangerousness of worry. Scores range from 6-24. Greater scores represent greater negative beliefs about worry. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Attention Control Scale | Self-report measure of attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control. | Participants were only included on this analyses if they had data for all time points. 1 participant was not included from the control condition. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Dot Probe | Behavioural measure of attentional bias to threat related words, measured in reaction time. A larger positive number indicates a greater bias to threat information while a negative number indicates the participant was faster to respond to neutral information. | Participants were only included on this analyses if they had data for all time points. 17 participants were not included (10 from ATT, 7 from control). A substantial amount of data was lost due to a technical issue with the computer. | Posted | Mean | Standard Deviation | miliseconds | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Secondary | Southampton Mindfulness Questionnaire | Self-report measure of mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| Other Pre-specified | UPPS-P | Self-report measure of impulsivity. Scores range from 12 to 48. Greater scores indicate greater negative urgency. | Posted | Mean | Standard Deviation | score on a scale | Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention). |
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| 0 |
| 34 |
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| 34 |
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| 34 |
| EG001 | Control Condition | Participants in this arm will listen to the control condition recording. Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week. For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day. Control Condition: In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions. | 0 | 44 | 0 | 44 | 0 | 44 |
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HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry |
| Mixed Models Analysis |
| .44 |
this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05. |
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HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention |
| Mixed Models Analysis |
| .02 |
The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared). |
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