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| ID | Type | Description | Link |
|---|---|---|---|
| K08MH120341 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Eating disorders (EDs) are serious mental illnesses associated with high morbidity and mortality, clinical impairment, and comorbid psychopathology. Although evidence-based treatments for EDs have been established, the treatment gap is wide. Indeed, <20% of individuals with EDs receive treatment. There is need for a novel solution not only to identify individuals with EDs but also to encourage mental health services use and to address treatment barriers. This study aims to implement a conversational agent or "chatbot" that is optimized to increase mental health services use among individuals with EDs through such features as: 1) education on the seriousness and consequences of EDs; 2) engaging the user in motivational interviewing to overcome barriers to care; 3) providing a personalized recommendation for seeking intervention; 4) repeated check-ins with the user to encourage follow-up with care. This study will utilize a randomized optimization trial with adults who have completed screening on the National Eating Disorders Association (NEDA) website and screen positive for an ED but are not in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot on motivation for treatment and mental health services use. This trial will employ the Multiphase Optimization Strategy framework, using a 2^4 full factorial design, to randomly assign participants to a combination of the four proposed intervention components (n=16 conditions) to isolate the active ingredients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeated Administration | Experimental |
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| Personalized Recommendation | Experimental |
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| Motivational Interviewing | Experimental |
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| Core Modules Only | Experimental |
| |
| Motivational Interviewing, Personalized Recommendation, Repeated Administration | Experimental |
| |
| Motivational Interviewing, Repeated Administration | Experimental |
| |
| Motivational Interviewing, Personalized Recommendation | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeated Administration | Behavioral | A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening | Treatment utilization was measured at each follow-up time point (2, 6, and 14 weeks), which was assessed via the prompt, "Have you tried or used any type of mental health help (e.g., self-help app, telehealth/in-person counseling, etc.) for your concerns related to your eating, shape, or weight in the past [2, 6, or 14] weeks?". We defined a participant as having utilized treatment at the first time they responded, "yes" (vs. "no") to this question. The data presented below indicate the rates of self-reported receipt of treatment/services utilization among participants assigned (component on) or not assigned (component off) to each of the four chatbot components (motivational interviewing, psychoeducation, personalized recommendations, repeated administration), as delineated by each time point during which the aforementioned item was assesed. | 2, 6, 14 Weeks from Engagement with the Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Willingness to Seek Psychotherapy | Participants' willingness to seek psychotherapy was assessed via an identical item in the baseline assessment (i.e., before the initial chatbot assessment) as well as each off the follow-up assessments delivered at 2, 6, and 14 weeks post-intervention. The item prompted users to rate their willingness to seek in-person or telehealth psychotherapy in subsequent weeks. Responses were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready). Mean values reported below indicate the average Likert scale willingness rating among all participants at each time point who did (component turned on) and did not (component turned off). Statistical analyses outline the time and component effects on changes in mean willingness to seek pyschotherapy from baseline to 14 weeks post-interventioon. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen E Fitzsimmons-Craft, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39072846 | Derived | Fitzsimmons-Craft EE, Rackoff GN, Shah J, Strayhorn JC, D'Adamo L, DePietro B, Howe CP, Firebaugh ML, Newman MG, Collins LM, Taylor CB, Wilfley DE. Effects of Chatbot Components to Facilitate Mental Health Services Use in Individuals With Eating Disorders Following Online Screening: An Optimization Randomized Controlled Trial. Int J Eat Disord. 2024 Nov;57(11):2204-2216. doi: 10.1002/eat.24260. Epub 2024 Jul 28. |
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Individuals who completed the NEDA screen and met all eligibility criteria were shown the baseline assessment. Individuals who completed the baseline, were U.S. residents, and endorsed owning a smartphone were shown the consent form. N= 205 individuals provided consent and were randomized to a condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Repeated Administration | Repeated Administration: A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG001 | Personalized Recommendation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 1, 2021 |
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|
| Personalized Recommendation, Repeated Administration | Experimental |
|
| Psychoeducation | Experimental |
|
| Psychoeducation, Repeated Administration | Experimental |
|
| Psychoeducation, Personalized Recommendation | Experimental |
|
| Psychoeducation, Motivational Interviewing | Experimental |
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| Psychoeducation, Motivational Interviewing, Personalized Recommendation | Experimental |
|
| Psychoeducation, Personalized Recommendation, Repeated Administration | Experimental |
|
| Psychoeducation, Motivational Interviewing, Repeated Administration | Experimental |
|
| Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Experimental |
|
| Personalized Recommendation | Behavioral | A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder. |
|
| Motivational Interviewing | Behavioral | A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
|
| Core Modules Only | Behavioral | A discussion with the chatbot, including only the core modules. |
|
| Motivational Interviewing, Personalized Recommendation, Repeated Administration | Behavioral | A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Motivational Interviewing, Repeated Administration | Behavioral | A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Motivational Interviewing, Personalized Recommendation | Behavioral | A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder. |
|
| Personalized Recommendation, Repeated Administration | Behavioral | A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Psychoeducation | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders. |
|
| Psychoeducation, Repeated Administration | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Psychoeducation, Personalized Recommendation | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder. |
|
| Psychoeducation, Motivational Interviewing | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
|
| Psychoeducation, Motivational Interviewing, Personalized Recommendation | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder. |
|
| Psychoeducation, Personalized Recommendation, Repeated Administration | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Psychoeducation, Motivational Interviewing, Repeated Administration | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Behavioral | A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
|
| Baseline, 2 Weeks, 6 Weeks, 14 Weeks |
| Mean Attitude Toward Change for Concerns Related to Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening | Participants' attitudes toward making changes (i.e., motivation toward seeking help) to address their personal eating, shape, and weight concerns were measured via identical items in the baseline assessment, and in each of the 2, 6, and 14 week follow-up assessments. Items included, "How important is it for you to change your eating, shape, or weight concerns?" and, "How ready are you to make changes in your eating, shape, or weight concerns?". Both items were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready), and the sum of the two questions was used as an index of change/motivation attitudes. Values below indicate the average Likert scale attitude rating (from 2 (lowest) to 14 (highest)) among all participants at each time point who did (component turned on) and did not (component turned off) receive each component. Analyses outline the time, component, and time by component interaction effects on changes in motivation attitudes since baseline. | Baseline, 2 weeks, 6 weeks, 14 weeks |
Personalized Recommendation: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.
| FG002 | Motivational Interviewing | Motivational Interviewing: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
| FG003 | Core Modules Only | Core Modules Only: A discussion with the chatbot, including only the core modules. |
| FG004 | Motivational Interviewing, Personalized Recommendation, Repeated Administration | Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG005 | Motivational Interviewing, Repeated Administration | Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG006 | Motivational Interviewing, Personalized Recommendation | Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder. |
| FG007 | Personalized Recommendation, Repeated Administration | Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG008 | Psychoeducation | Psychoeducation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders. |
| FG009 | Psychoeducation, Repeated Administration | Psychoeducation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG010 | Psychoeducation, Personalized Recommendation | Psychoeducation, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder. |
| FG011 | Psychoeducation, Motivational Interviewing | Psychoeducation, Motivational Interviewing: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
| FG012 | Psychoeducation, Motivational Interviewing, Personalized Recommendation | Psychoeducation, Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder. |
| FG013 | Psychoeducation, Personalized Recommendation, Repeated Administration | Psychoeducation, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG014 | Psychoeducation, Motivational Interviewing, Repeated Administration | Psychoeducation, Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| FG015 | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| Completed 2-Week Follow-Up Assessment |
|
| Completed 6-Week Follow-Up Assessment |
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| Completed 14-Week Follow-Up Assessment |
|
| COMPLETED |
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| NOT COMPLETED |
|
Following screening, individuals were shown the baseline assessment link if they met the following eligibility criteria: screened positive for a clinical/subclinical ED, not currently in treatment for an ED, and at least 18 years old. U.S residents who completed the baseline assessment and endorsed owning a smartphone were offered to participate and shown the consent form. N=205 individuals provided sent and were randomized to one of sixteen conditions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Repeated Administration | Repeated Administration: A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG001 | Personalized Recommendation | Personalized Recommendation: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder. |
| BG002 | Motivational Interviewing | Motivational Interviewing: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
| BG003 | Core Modules Only | Core Modules Only: A discussion with the chatbot, including only the core modules. |
| BG004 | Motivational Interviewing, Personalized Recommendation, Repeated Administration | Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG005 | Motivational Interviewing, Repeated Administration | Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG006 | Motivational Interviewing, Personalized Recommendation | Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder. |
| BG007 | Personalized Recommendation, Repeated Administration | Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG008 | Psychoeducation | Psychoeducation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders. |
| BG009 | Psychoeducation, Repeated Administration | Psychoeducation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG010 | Psychoeducation, Personalized Recommendation | Psychoeducation, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder. |
| BG011 | Psychoeducation, Motivational Interviewing | Psychoeducation, Motivational Interviewing: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. |
| BG012 | Psychoeducation, Motivational Interviewing, Personalized Recommendation | Psychoeducation, Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder. |
| BG013 | Psychoeducation, Personalized Recommendation, Repeated Administration | Psychoeducation, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG014 | Psychoeducation, Motivational Interviewing, Repeated Administration | Psychoeducation, Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG015 | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. |
| BG016 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Rates of Treatment/Services Utilization for Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening | Treatment utilization was measured at each follow-up time point (2, 6, and 14 weeks), which was assessed via the prompt, "Have you tried or used any type of mental health help (e.g., self-help app, telehealth/in-person counseling, etc.) for your concerns related to your eating, shape, or weight in the past [2, 6, or 14] weeks?". We defined a participant as having utilized treatment at the first time they responded, "yes" (vs. "no") to this question. The data presented below indicate the rates of self-reported receipt of treatment/services utilization among participants assigned (component on) or not assigned (component off) to each of the four chatbot components (motivational interviewing, psychoeducation, personalized recommendations, repeated administration), as delineated by each time point during which the aforementioned item was assesed. | All participants who engaged with the intervention and completed the treatment utilization item at each follow up assessment (2, 6, and 14 weeks post intervention) are included. Participants in each of the 16 factorial conditions were sorted based on whether or not each of the four chatbot components were assigned. This method was used in order to understand which combination of components are essential in the design of an optimized chatbot for use in a future randomized controlled trial. | Posted | Count of Participants | Participants | No | 2, 6, 14 Weeks from Engagement with the Intervention |
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| Secondary | Mean Willingness to Seek Psychotherapy | Participants' willingness to seek psychotherapy was assessed via an identical item in the baseline assessment (i.e., before the initial chatbot assessment) as well as each off the follow-up assessments delivered at 2, 6, and 14 weeks post-intervention. The item prompted users to rate their willingness to seek in-person or telehealth psychotherapy in subsequent weeks. Responses were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready). Mean values reported below indicate the average Likert scale willingness rating among all participants at each time point who did (component turned on) and did not (component turned off). Statistical analyses outline the time and component effects on changes in mean willingness to seek pyschotherapy from baseline to 14 weeks post-interventioon. | The analysis population included those individuals who did not report utilizing treatment/services at any of the three follow-up assessments. Treatment utilization was assessed via the item,"Have you tried or used any type of mental health help (e.g., self-help app, telehealth/in-person counseling, etc.) for your concerns related to your eating, shape, or weight in the past past [2, 6, or 14] weeks?" Participants who did not respond "yes" to this item were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 Weeks, 6 Weeks, 14 Weeks |
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| Secondary | Mean Attitude Toward Change for Concerns Related to Eating, Shape, or Weight Concerns Among All Participants Randomized to the Intervention Following Online Eating Disorder Screening | Participants' attitudes toward making changes (i.e., motivation toward seeking help) to address their personal eating, shape, and weight concerns were measured via identical items in the baseline assessment, and in each of the 2, 6, and 14 week follow-up assessments. Items included, "How important is it for you to change your eating, shape, or weight concerns?" and, "How ready are you to make changes in your eating, shape, or weight concerns?". Both items were rated on a Likert scale from 1 (not at all important/ready) to 7 (very important/ready), and the sum of the two questions was used as an index of change/motivation attitudes. Values below indicate the average Likert scale attitude rating (from 2 (lowest) to 14 (highest)) among all participants at each time point who did (component turned on) and did not (component turned off) receive each component. Analyses outline the time, component, and time by component interaction effects on changes in motivation attitudes since baseline. | All participants randomized to the intervention (n=205) were included, with missing data accommodated using maximum likelihood estimation. This study uses a factorial design; participants were randomized to one of 16 conditions, with each condition receiving a different combination of the four chatbot components (motivational interviewing, psychoeducation, personalized recommendations, repeated administration) turned off or on. Data below are presented as such. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 6 weeks, 14 weeks |
|
Adverse event data were collected for up to 14-weeks following baseline assessment.
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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 | Repeated Administration | Repeated Administration: A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | Personalized Recommendation | Personalized Recommendation: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Motivational Interviewing | Motivational Interviewing: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Core Modules Only | Core Modules Only: A discussion with the chatbot, including only the core modules. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG004 | Motivational Interviewing, Personalized Recommendation, Repeated Administration | Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | Motivational Interviewing, Repeated Administration | Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG006 | Motivational Interviewing, Personalized Recommendation | Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG007 | Personalized Recommendation, Repeated Administration | Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG008 | Psychoeducation | Psychoeducation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG009 | Psychoeducation, Repeated Administration | Psychoeducation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG010 | Psychoeducation, Personalized Recommendation | Psychoeducation, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG011 | Psychoeducation, Motivational Interviewing | Psychoeducation, Motivational Interviewing: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG012 | Psychoeducation, Motivational Interviewing, Personalized Recommendation | Psychoeducation, Motivational Interviewing, Personalized Recommendation: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG013 | Psychoeducation, Personalized Recommendation, Repeated Administration | Psychoeducation, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG014 | Psychoeducation, Motivational Interviewing, Repeated Administration | Psychoeducation, Motivational Interviewing, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG015 | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration | Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration: A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder. | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen E. Fitzsimmons-Craft | Washington University in St. Louis School of Medicine | 314-286-2074 | fitzsimmonse@wustl.edu |
| May 16, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| 25-34 |
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| 35-44 |
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| 45-54 |
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| 55-64 |
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| 65-74 |
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| Male |
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| Non-binary/third gender |
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| Prefer not to say |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants were randomized to a chatbot condition that did not include the psychoeducation component of the conversation (i.e., the psychoeducation component was turned off during the chatbot conversations of these participants). |
| OG006 | Repeated Administration On | Participants were randomized to a chatbot condition that included the repeated administration component of the conversation (i.e., the repeated administration component was turned on during the chatbot conversations of these participants). Participants in this group received up to three check-ins from the chatbot over the course of the next 9 days. At the first check-in, which occurred 3 days after the main conversation, the chatbot asked users if they had sought help or used any of the recommended tools/services since they last conversed. If users do not report seeking help and/or utilizing services, they continued to receive check-ins until treatment receipt was provided. |
| OG007 | Repeated Administration Off | Participants were randomized to a chatbot condition that did not include the repeated administration component of the conversation (i.e., the repeated administration component was turned off during the chatbot conversations of these participants). Participants in this group completed the main conversation with the chatbot, which consisted of the introduction, a combination of the motivational interviewing, personalized recommendation, and psychoeducation components (which was determined by which of the 16 conditions participants were randomized to), and the corresponding conclusion. The conversation with the chatbot terminated following the conclusion, and the chatbot did not message users subsequently (unless users reached out to the chatbot first). |
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| Number of Participants Reporting New Treatment Receipt at 6 Weeks from Baseline |
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| Number of Participants Reporting New Treatment Receipt at 14 Weeks from Baseline |
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| Cumulative Sum of Participants Reporting Treatment Receipt over Study Period |
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| Superiority |
To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | .190 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | .34 | Standard Error of the Mean | 0.26 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | .690 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | -0.10 | Standard Error of the Mean | 0.26 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | 0.038 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | 0.54 | Standard Error of the Mean | 0.26 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | .735 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | 0.06 | Standard Error of the Mean | 0.16 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | .001 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | -0.91 | Standard Error of the Mean | 0.27 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component. | Discrete Time Survival Analysis | The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment. | .014 | We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large. | Regression (Beta) Coefficient | -0.73 | Standard Error of the Mean | 0.30 | 2-Sided | Superiority | To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept. |
| OG001 | Motivational Interviewing Off | Participants were randomized to a chatbot condition that did not include the motivational interviewing component of the conversation (i.e., the motivational interviewing component was turned off during the chatbot conversations of these participants). |
| OG002 | Personalized Recommendation On | Participants were randomized to a chatbot condition that included the personalized recommendations component of the conversation (i.e., the personalized recommendations component was turned on during the chatbot conversations of these participants). |
| OG003 | Personalized Recommendation Off | Participants were randomized to a chatbot condition that did not include the personalized recommendations component of the conversation (i.e., the personalized recommendations component was turned off during the chatbot conversations of these participants). Instead, these participants received general recommendations for treatment and services. |
| OG004 | Psychoeducation On | Participants were randomized to a chatbot condition that included the psychoeducation component of the conversation (i.e., the psychoeducation component was turned on during the chatbot conversations of these participants). |
| OG005 | Psychoeducation Off | Participants were randomized to a chatbot condition that did not include the psychoeducation component of the conversation (i.e., the psychoeducation component was turned off during the chatbot conversations of these participants). |
| OG006 | Repeated Administration On | Participants were randomized to a chatbot condition that included the repeated administration component of the conversation (i.e., the repeated administration component was turned on during the chatbot conversations of these participants). Participants in this group received up to three check-ins from the chatbot over the course of the next 9 days. At the first check-in, which occurred 3 days after the main conversation, the chatbot asked users if they had sought help or used any of the recommended tools/services since they last conversed. If users do not report seeking help and/or utilizing services, they continued to receive check-ins until treatment receipt was provided. |
| OG007 | Repeated Administration Off | Participants were randomized to a chatbot condition that did not include the repeated administration component of the conversation (i.e., the repeated administration component was turned off during the chatbot conversations of these participants). Participants in this group completed the main conversation with the chatbot, which consisted of the introduction, a combination of the motivational interviewing, personalized recommendation, and psychoeducation components (which was determined by which of the 16 conditions participants were randomized to), and the corresponding conclusion. The conversation with the chatbot terminated following the conclusion, and the chatbot did not message users subsequently (unless users reached out to the chatbot first). |
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Participants were randomized to a chatbot condition that included the motivational interviewing component of the conversation (i.e., the motivational interviewing component was turned on during the chatbot conversations of these participants). |
| OG001 | Motivational Interviewing Off | Participants were randomized to a chatbot condition that did not include the motivational interviewing component of the conversation (i.e., the motivational interviewing component was turned off during the chatbot conversations of these participants). |
| OG002 | Personalized Recommendation On | Participants were randomized to a chatbot condition that included the personalized recommendations component of the conversation (i.e., the personalized recommendations component was turned on during the chatbot conversations of these participants). |
| OG003 | Personalized Recommendation Off | Participants were randomized to a chatbot condition that did not include the personalized recommendations component of the conversation (i.e., the personalized recommendations component was turned off during the chatbot conversations of these participants). Instead, these participants received general recommendations for treatment and services. |
| OG004 | Psychoeducation On | Participants were randomized to a chatbot condition that included the psychoeducation component of the conversation (i.e., the psychoeducation component was turned on during the chatbot conversations of these participants). |
| OG005 | Psychoeducation Off | Participants were randomized to a chatbot condition that did not include the psychoeducation component of the conversation (i.e., the psychoeducation component was turned off during the chatbot conversations of these participants). |
| OG006 | Repeated Administration On | Participants were randomized to a chatbot condition that included the repeated administration component of the conversation (i.e., the repeated administration component was turned on during the chatbot conversations of these participants). Participants in this group received up to three check-ins from the chatbot over the course of the next 9 days. At the first check-in, which occurred 3 days after the main conversation, the chatbot asked users if they had sought help or used any of the recommended tools/services since they last conversed. If users do not report seeking help and/or utilizing services, they continued to receive check-ins until treatment receipt was provided. |
| OG007 | Repeated Administration Off | Participants were randomized to a chatbot condition that did not include the repeated administration component of the conversation (i.e., the repeated administration component was turned off during the chatbot conversations of these participants). Participants in this group completed the main conversation with the chatbot, which consisted of the introduction, a combination of the motivational interviewing, personalized recommendation, and psychoeducation components (which was determined by which of the 16 conditions participants were randomized to), and the corresponding conclusion. The conversation with the chatbot terminated following the conclusion, and the chatbot did not message users subsequently (unless users reached out to the chatbot first). |
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