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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 9/19/2025 | Other Identifier | UW Madison | |
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW Madison | |
| A538900 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| University of Toronto | OTHER |
| Radboud University Medical Center | OTHER |
| Explore DEEP Inc | UNKNOWN |
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The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.
The goal of this proposal is to determine the feasibility of a novel virtual-reality-based biofeedback (VR-B) treatment among youth highly vulnerable to difficulties in emotional regulation. Biofeedback, which involves the provision of real-time information about physiology, is a well-studied approach to enhancing self-regulatory ability, with potential promise for alleviating mental health problems. In children (as well as adults), biofeedback may be ideally facilitated through video game environments, which offer engaging, immersive, yet dynamic environments that can be changed in real-time. Video games are enormously popular with youth, and may represent an important avenue for treatment in adolescent populations. The current proposal aims to evaluate a novel virtual-reality-based video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. Exposure to risk factors known to promote impaired self-regulation, such as child mal-treatment, is nearly endemic in this population. Indeed, 'delinquent' youth (i.e., youth in contact with the justice system) are considerably more likely to meet diagnostic criteria for a range of disorders centrally involving dysregulation of affect or arousal, such as post-traumatic stress disorder, anxiety, depression, oppositional defiant disorder, and many others.
Specific Aims:
AIM 1: Evaluate the feasibility of a virtual reality treatment for youth
AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions
AIM 3: Identify potential changes in symptom severity across treatment sessions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEEP VR Experiment Group | Experimental | Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEEP VR | Device | DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey | Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable". | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Difficulty in Emotion Regulation Scale (DERS) | The DERS is a 36-item child-report survey measuring difficulties with emotion regulation. Respondents report the degree to which the given statement applied to them on a five point Likert scale: 1 = Almost Never to 5 = Always, with a possible total score range of 36 - 180. Higher scores indicate greater difficulties with emotion regulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan J Herringa, MD,PhD | University of Wisconsin, Madison | Principal Investigator |
| Justin D Russell, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8379556 | Background | Warshaw MG, Fierman E, Pratt L, Hunt M, Yonkers KA, Massion AO, Keller MB. Quality of life and dissociation in anxiety disorder patients with histories of trauma or PTSD. Am J Psychiatry. 1993 Oct;150(10):1512-6. doi: 10.1176/ajp.150.10.1512. | |
| Background | Zafar, M. A., Ahmed, B., Rihawi, R. A., & Gutierrez-Osuna, R. (2020). Gaming Away Stress: Using Biofeedback Games to Learn Paced Breathing. IEEE Transactions on Affective Computing, 11(3), 519-531. https://doi.org/10.1109/TAFFC.2018.2816945 | ||
| 29376669 |
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Information to be shared may include questionnaire responses, physiological recordings, or game play data. These data will be coded with the unique subject ID, and will not include any linking protected health information or other identifiable information. Data will be shared via encrypted, password protected cloud storage (Box.com).
Immediately upon study start.
Information will only be shared with the following individuals with knowledge of the methodology and analyses in this intervention:
Dr. Isabele Granic, University of Toronto Joanneke Weerdmeester, Radboud University Owen L. Harris, Explore DEEP Inc.
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| ID | Title | Description |
|---|---|---|
| FG000 | DEEP VR Experiment Group | Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires. DEEP VR: DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
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| Overall Study |
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Baseline demographics were not collected from the participant who withdrew.
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| ID | Title | Description |
|---|---|---|
| BG000 | DEEP VR Experiment Group | Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires. DEEP VR: DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Feasibility: Number of Participants Who Enjoyed VR Simulation Experience: Determined Via Qualitative Survey | Rated between neutral and strongly agree to the question: "I found the virtual environment to be engaging and enjoyable". | 11 Participants did not complete the survey. | Posted | Count of Participants | Participants | up to 8 weeks |
|
2 weeks
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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 | DEEP VR Experiment Group | Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires. DEEP VR: DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Heyn, PhD, JD | University of Wisconsin - Madison | 303-396-2116 | sheyn@wisc.edu |
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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 | Sep 19, 2025 | Mar 31, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2023 | Mar 31, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000080103 | Emotional Regulation |
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
| Physiological Arousal Measured by Change in Heart Rate | Participants will have electrodes affixed to their abdomen to measure heart rate. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions. | Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
| Physiological Arousal Measured by Change in Galvanic Skin Response | Participants will have electrodes affixed to their fingers to measure skin response. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions. | Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
| Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale | The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Positive sub-scale is the sum of positive items in the VR-B engagement survey (total range of scores from 4-28). Positive change scores indicate that the VR experience got more positive over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline). | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
| Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale | The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Negative sub-scale is the sum of negative items in the VR-B engagement survey (total possible range of scores from 4-28). Positive change scores indicate that the VR experience got less negative over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline). | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
| Mean Change in Child PTSD Symptom Scale (CPSS) | Assesses lifetime trauma experiences and severity of PTSD symptom severity in a 20-item survey scored on a 5-point likert scale from 0 'not at all' to 4 'almost always' for a total range of scores between 0 - 80, where higher scores indicate increased PTSD symptoms. | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
| Background |
| Rizzo AS, Koenig ST. Is clinical virtual reality ready for primetime? Neuropsychology. 2017 Nov;31(8):877-899. doi: 10.1037/neu0000405. |
| 32847397 | Background | Fonkoue IT, Hu Y, Jones T, Vemulapalli M, Sprick JD, Rothbaum B, Park J. Eight weeks of device-guided slow breathing decreases sympathetic nervous reactivity to stress in posttraumatic stress disorder. Am J Physiol Regul Integr Comp Physiol. 2020 Oct 1;319(4):R466-R475. doi: 10.1152/ajpregu.00079.2020. Epub 2020 Aug 26. |
| 22300910 | Background | Fang X, Brown DS, Florence CS, Mercy JA. The economic burden of child maltreatment in the United States and implications for prevention. Child Abuse Negl. 2012 Feb;36(2):156-65. doi: 10.1016/j.chiabu.2011.10.006. Epub 2012 Feb 1. |
| 17485609 | Background | Copeland WE, Keeler G, Angold A, Costello EJ. Traumatic events and posttraumatic stress in childhood. Arch Gen Psychiatry. 2007 May;64(5):577-84. doi: 10.1001/archpsyc.64.5.577. |
| 31616353 | Background | Blum J, Rockstroh C, Goritz AS. Heart Rate Variability Biofeedback Based on Slow-Paced Breathing With Immersive Virtual Reality Nature Scenery. Front Psychol. 2019 Sep 20;10:2172. doi: 10.3389/fpsyg.2019.02172. eCollection 2019. |
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| Sex: Female, Male | Gender is unknown for the other 6 participants | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Historical and current delinquency offenses | Count of Participants | Participants |
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| Youth Self-Report (YSR) Total Score | YSR Total Score ranges from 0-166, where higher scores indicate more behavioral issues | Mean | Standard Deviation | score on a scale |
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| Youth Self-Report (YSR) Sub-Scores | Internalizing Sub-Score ranges 0-62, with higher scores indicating higher internalizing symptoms (e.g., depression, anxiety) Externalizing Sub-Score ranges 0-62, with higher scores indicating higher externalizing behaviors (e.g., aggression, impulsivity, rule-breaking, defiance, etc.) | Mean | Standard Deviation | score on a scale |
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| Childhood Trauma Questionnaire (CTQ) | Scored from 28-140 with higher scores indicate higher frequency and severity of childhood maltreatment experiences (e.g., abuse, neglect). | Mean | Standard Deviation | score on a scale |
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| Child PTSD Symptom Scale for DSM-5 (CPSS-V) | Scored from 0-80 with higher scores indicating more severe Post Traumatic Stress Disorder (PTSD) symptoms. | Mean | Standard Deviation | score on a scale |
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| Secondary | Mean Change in Difficulty in Emotion Regulation Scale (DERS) | The DERS is a 36-item child-report survey measuring difficulties with emotion regulation. Respondents report the degree to which the given statement applied to them on a five point Likert scale: 1 = Almost Never to 5 = Always, with a possible total score range of 36 - 180. Higher scores indicate greater difficulties with emotion regulation. | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | score on a scale | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
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| Secondary | Physiological Arousal Measured by Change in Heart Rate | Participants will have electrodes affixed to their abdomen to measure heart rate. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions. | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | beats per millisecond | Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
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| Secondary | Physiological Arousal Measured by Change in Galvanic Skin Response | Participants will have electrodes affixed to their fingers to measure skin response. Before every session, baseline levels of physiological arousal will be captured over a 5 minute resting period. Participants will be asked to sit quietly within a serene virtual outdoor scene followed by a 15 minute DEEP VR experience containing several task conditions. | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | microsiemens (µS) | Change measured throughout the 15 minute VR session at baseline and before and after each task condition, sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
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| Secondary | Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Positive Sub-scale | The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Positive sub-scale is the sum of positive items in the VR-B engagement survey (total range of scores from 4-28). Positive change scores indicate that the VR experience got more positive over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline). | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | score on a scale | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
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| Secondary | Mean Change in Virtual-Reality Biofeedback Engagement Survey (VR-B) From Baseline: VR-B Negative Sub-scale | The VR-B is a 10-item child-report survey measuring engagement with the virtual-reality biofeedback intervention. Respondents select the degree to which they agree with each statement along a Likert scale: 1 = Strongly Disagree to 7 = Strongly Agree. The VR-B Negative sub-scale is the sum of negative items in the VR-B engagement survey (total possible range of scores from 4-28). Positive change scores indicate that the VR experience got less negative over time. Reported here is the change in the sub-score from baseline (session 1) through session 6 (up to 2 weeks from baseline). | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | score on a scale | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
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| Secondary | Mean Change in Child PTSD Symptom Scale (CPSS) | Assesses lifetime trauma experiences and severity of PTSD symptom severity in a 20-item survey scored on a 5-point likert scale from 0 'not at all' to 4 'almost always' for a total range of scores between 0 - 80, where higher scores indicate increased PTSD symptoms. | Participants left the facility prior to completing all 6 sessions. 1 participant withdrew. | Posted | Mean | Standard Deviation | score on a scale | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
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| Post-Hoc | Number of Sessions Completed | Mean number of sessions each participant completed | 1 participant withdrew | Posted | Mean | Standard Deviation | sessions completed | Sessions typically occurred once a day, participating on up to 6 days within a 1-2 week period, individual participant data collection spanned from 1 day to 2 weeks depending on if participant left the facility before completing all sessions. |
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| Post-Hoc | Average Length of Session | 1 participant withdrew | Posted | Mean | Standard Deviation | minutes | Sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
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| Post-Hoc | Average Total Minutes in Game | 1 participant withdrew | Posted | Mean | Standard Deviation | minutes | Sessions typically occurred once a day, participating on 6 days within a 1-2 week period |
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