Anorexia Nervosa/Bulimia, Anorexia in Adolescence, Anorexia Nervosa, Atypical, Anorexia Nervosa, Binge Eating/Purging Type, Purging (Eating Disorders), Impulsive Behavior, Eating Disorders, Bulimia Nervosa, Eating Disorders in Adolescence
Conditions
Brief summary
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.
Detailed description
Subjects participating in this study will receive routine care for eating disorder at a partial hospitalization (PHP) level of care at MSHMC. In PHP, all patients have weekly medical screening visits for the duration of their time in care, as well as weekly individual therapy sessions, individual dietician sessions, and psychiatry appointments. They have supervised meals and numerous group therapy sessions. Every three weeks, patients in PHP complete a battery of mood and eating disorder indices including those evaluated in this study; participants in this study will complete an additional two surveys with this routine battery. Participants in this study will have no alterations in their routine eating disorder care outside of study article use and these additional surveys. Subjects will be enrolled at their first visit for eating disorder programming at child or adult partial hospitalization (PHP) programming at MSHMC adolescent medicine eating disorders clinic. Informed consent/assent will be obtained as described above. The subject will be provided with oral naltrexone or placebo weekly from the MSHMC research pharmacy. Subjects will be given one weeks' worth of medication at a time. Subjects will be randomized at enrollment to receive either study drug (naltrexone) or placebo. Participants or parents of minor participants will be provided study drug or placebo following completion of urine drug screen and consent/assent. Patients will take the medication daily for six weeks. For subjects who are enrolled in child PHP and who eat meals with parents, the families may choose to administer study drug during meals at programming. For adult patients enrolled in adult programming, subjects may choose to self-administer the medication. On their first contact with PHP, all patients in Child PHP complete various eating disorder indices as a part of routine care, including the ED-15, EDE-Q, RCMAS, CDI, GAD-7, and PHQ-9. This battery of indices is repeated every 3 weeks while a patient is in programming. For those who are enrolled in this study, they will complete their routine indices, in addition they will also complete the BIS/BAS and the ABUSI at enrollment and at weeks 3, 6, and 9 (after completion of medication) while in programming. Participants will receive routine eating disorder care while in PHP. Patients in Adult PHP typically complete a different inventory every three weeks. If a patient chooses to participate in this study they will be asked to complete the same surveys as participants in Child PHP, and they will receive the same amount and type of compensation. Six months after enrollment, subjects will be sent copies of ED-15, EDE-Q, GAD-7, PHQ-9, BIS/BAS, and ABUSI indices either in an in-person medical appointment or via RedCap to complete. If the patient returns for medical follow-up between 5 and 7 months after enrollment, their height, weight, and body mass index will also be recorded to determine if weight restoration was maintained. At initial contact with the eating disorders clinic, all patients receive an initial battery of laboratory tests as a part of the standard of care for eating disorder. These tests include liver function assays and transaminase levels.
Interventions
25mg x 3 days then 50mg a day thereafter
OTHERControl
Methylcellulose and gelatin capsule only
Sponsors
Children's Miracle Network
Rosemary Claire Roden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets from a pharmaceutical wholesaler. The IDS pharmacy will purchase gelatin capsules and USP grade methylcellulose from a pharmacy supplier to be used for compounding the active and placebo capsules. For the active Naltrexone 50mg capsules, a Naltrexone 50mg tablet will be placed in an empty gelatin capsule with methylcellulose filler. The placebo capsules will be empty gelatin capsules filled with Methylcellulose. Participants will be randomized using redcap at enrollment to either study article or placebo, and neither investigators nor care providers will be aware of which article the participants receive.
Intervention model description
double-blind, placebo controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Ages 13-25 (inclusive) * Any sex * Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria * Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC The diagnostic criteria for anorexia nervosa, binge-purge subtype, are: A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected. B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight. C. Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study The diagnostic criteria for bulimia nervosa are: A. Recurrent episodes of binge eating. An episode of binge eating is characterized by B. both: i. Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating. C. Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise. D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months. E. Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa. • The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the absence of binge eating.
Exclusion criteria
* Diagnosis of intellectual disability * History of known genetic or neurologic disease * Need for treatment with opioid painkillers * Weight \<25kg * Inability to swallow pills * Lack of proficiency in written or spoken English * Urine drug screen positive for opioids at enrollment * Positive serum pregnancy test at enrollment * Lactation * Elevation of three times the upper limit of normal for age in either alanine aminotransferase (ALT) or asparagine aminotransferase (AST).High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for participants age 18-25) or Ask Suicide Screening Questions (ASQ, participants age 13 to 17)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED-15 Score | Time Frame: Measured at the following timepoints: enrollment | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Examination Questionnaire Score (EDE-Q) | Measured at the following timepoints: enrollment | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. |
| Patient Health Questionnaire Score (PHQ-9) | Measured at the following timepoints: enrollment | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression |
| Generalized Anxiety Disorder Screener Score (GAD-7) | Measured at the following timepoints: enrollment | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety |
| Alexian Brothers Urge to Self-Injure Scale (ABUSI) | Measured at the following timepoints: enrollment | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure |
| Percent of Weight Restoration | Will evaluate total percent of weight restoration via chart review at 9 weeks | For participants who need to restore weight, will evaluate the percent of weight gain in care |
| Need For Higher Level of Care | Will evaluate need for higher level of care at nine weeks | Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility |
| Barratt Impulsiveness Scale (BIS-11) | Measured at the following timepoints: enrollment | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Columbia Suicide Severity Rating Scale (CSSRS) | Measured at enrollment for patients age 17 or older | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). |
| Ask Suicide Screening Questions (ASQ) | Measured at enrollment for patients age 16 or younger | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler
Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | 5 |
| Control Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks
Control: Methylcellulose and gelatin capsule only | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 17 years | 16.5 years | 16 years |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 1 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 3 / 5 | 4 / 4 |
| serious Total, serious adverse events | 0 / 5 | 1 / 4 |
Outcome results
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 0.866666667 score on a scale | Standard Deviation 0.776745347 |
| Control | ED-15 Score | 4.3 score on a scale | Standard Deviation 0 |
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 1.075 score on a scale | Standard Deviation 0.736545993 |
| Control | ED-15 Score | 4.5 score on a scale | Standard Deviation 0 |
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 1.825 score on a scale | Standard Deviation 1.701714821 |
| Control | ED-15 Score | 3.5 score on a scale | Standard Deviation 2.364318084 |
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: three week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 3.04 score on a scale | Standard Deviation 1.820164828 |
| Control | ED-15 Score | 4.025 score on a scale | Standard Deviation 1.508586535 |
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 3.5 score on a scale | Standard Deviation 2.016184515 |
| Control | ED-15 Score | 4.7 score on a scale | Standard Deviation 0.871779789 |
Primary
ED-15 Score
ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.
Time frame: Time Frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED-15 Score | 3.08 score on a scale | Standard Deviation 1.845806057 |
| Control | ED-15 Score | 4.675 score on a scale | Standard Deviation 0.784750491 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 3.4 score on a scale | Standard Deviation 3.435112807 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 7.25 score on a scale | Standard Deviation 7.632168761 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 3.6 score on a scale | Standard Deviation 4.098780306 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 5.75 score on a scale | Standard Deviation 4.924428901 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: three weeks
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 2.8 score on a scale | Standard Deviation 2.387467277 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 4.5 score on a scale | Standard Deviation 3.415650255 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 2.25 score on a scale | Standard Deviation 2.62995564 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 11 score on a scale | Standard Deviation 6.08276253 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 1.5 score on a scale | Standard Deviation 3 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 9 score on a scale | Standard Deviation 12.72792206 |
Secondary
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure
Time frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 0.333333333 score on a scale | Standard Deviation 0.577350269 |
| Control | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | 0 score on a scale | Standard Deviation 0 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 62.2 score on a scale | Standard Deviation 14.44645285 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 72.25 score on a scale | Standard Deviation 9.569918147 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 64 score on a scale | Standard Deviation 10.58300524 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 60 score on a scale | Standard Deviation 0 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 63.25 score on a scale | Standard Deviation 14.97497913 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 71 score on a scale | Standard Deviation 12.72792206 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 65.25 score on a scale | Standard Deviation 14.22146265 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 69.66666667 score on a scale | Standard Deviation 6.506407099 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: three weeks
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 64.4 score on a scale | Standard Deviation 12.77888884 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 69.5 score on a scale | Standard Deviation 5.744562647 |
Secondary
Barratt Impulsiveness Scale (BIS-11)
Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.
Time frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Barratt Impulsiveness Scale (BIS-11) | 64 score on a scale | Standard Deviation 17.88854382 |
| Control | Barratt Impulsiveness Scale (BIS-11) | 71 score on a scale | Standard Deviation 6.976149845 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 3.3925 score on a scale | Standard Deviation 1.8216 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 4.72031 score on a scale | Standard Deviation 0.806764613 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 0.753125 score on a scale | Standard Deviation 0.538770301 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 4.04375 score on a scale | Standard Deviation 0 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 1.6546875 score on a scale | Standard Deviation 1.524132053 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 3.2 score on a scale | Standard Deviation 2.385773263 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: three weeks
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.66375 score on a scale | Standard Deviation 1.553369573 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 3.9953125 score on a scale | Standard Deviation 1.634008483 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.87 score on a scale | Standard Deviation 1.744810385 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 4.315625 score on a scale | Standard Deviation 0.645285386 |
Secondary
Eating Disorder Examination Questionnaire Score (EDE-Q)
EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology.
Time frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Eating Disorder Examination Questionnaire Score (EDE-Q) | 2.4125 score on a scale | Standard Deviation 0.724577822 |
| Control | Eating Disorder Examination Questionnaire Score (EDE-Q) | 3.90625 score on a scale | Standard Deviation 0 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 6.75 score on a scale | Standard Deviation 4.645786622 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 10.33333333 score on a scale | Standard Deviation 3.511884584 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 10.8 score on a scale | Standard Deviation 3.271085447 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 13.75 score on a scale | Standard Deviation 5.560275773 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 7.4 score on a scale | Standard Deviation 3.577708764 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 12.75 score on a scale | Standard Deviation 4.716990566 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: three weeks
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 6.8 score on a scale | Standard Deviation 4.438468204 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 11 score on a scale | Standard Deviation 4.69041576 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 6 score on a scale | Standard Deviation 6.976149845 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 9 score on a scale | Standard Deviation 5.656854249 |
Secondary
Generalized Anxiety Disorder Screener Score (GAD-7)
evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety
Time frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder Screener Score (GAD-7) | 5.666666667 score on a scale | Standard Deviation 1.154700538 |
| Control | Generalized Anxiety Disorder Screener Score (GAD-7) | 6 score on a scale | Standard Deviation 0 |
Secondary
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Time frame: Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Need For Higher Level of Care | Need for Higher Level of Care | 0 Participants |
| Intervention | Need For Higher Level of Care | No Need for Higher Level of Care | 2 Participants |
| Control | Need For Higher Level of Care | Need for Higher Level of Care | 1 Participants |
| Control | Need For Higher Level of Care | No Need for Higher Level of Care | 0 Participants |
Secondary
Need For Higher Level of Care
Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility
Time frame: Will evaluate need for higher level of care at nine weeks
Population: We collected data for 8 out of 9 participants because an in-person visit was required for this variable to be evaluated. One participant was lost to follow-up and did not have an in-person visit at this time period.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Need For Higher Level of Care | Need for Higher Level of Care | 0 Participants |
| Intervention | Need For Higher Level of Care | No Need for Higher Level of Care | 4 Participants |
| Control | Need For Higher Level of Care | Need for Higher Level of Care | 0 Participants |
| Control | Need For Higher Level of Care | No Need for Higher Level of Care | 4 Participants |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: six weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 7.5 score on a scale | Standard Deviation 4.434711565 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 10.66666667 score on a scale | Standard Deviation 2.309401077 |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: three weeks
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 10.4 score on a scale | Standard Deviation 6.268971207 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 10.75 score on a scale | Standard Deviation 4.991659711 |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: one week
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 12.8 score on a scale | Standard Deviation 8.167006796 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 11.5 score on a scale | Standard Deviation 4.203173404 |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: 6 months after enrollment
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 4.666666667 score on a scale | Standard Deviation 5.507570547 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 4 score on a scale | Standard Deviation 0 |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: enrollment
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 13.8 score on a scale | Standard Deviation 8.043631021 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 12 score on a scale | Standard Deviation 4.966554809 |
Secondary
Patient Health Questionnaire Score (PHQ-9)
Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression
Time frame: Measured at the following timepoints: nine weeks (last week of treatment)
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire Score (PHQ-9) | 5.5 score on a scale | Standard Deviation 6.191391874 |
| Control | Patient Health Questionnaire Score (PHQ-9) | 12.5 score on a scale | Standard Deviation 9.192388155 |
Secondary
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Time frame: Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent of Weight Restoration | 100.5 percentage of weight restoration | Standard Deviation 10.60660172 |
| Control | Percent of Weight Restoration | 84.5 percentage of weight restoration | Standard Deviation 7.778174593 |
Secondary
Percent of Weight Restoration
For participants who need to restore weight, will evaluate the percent of weight gain in care
Time frame: Will evaluate total percent of weight restoration via chart review at 9 weeks
Population: Numbers reflect participants enrolled at this time point. Other participants are lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percent of Weight Restoration | 100.25 percentage of weight restoration | Standard Deviation 5.068 |
| Control | Percent of Weight Restoration | 94 percentage of weight restoration | Standard Deviation 12 |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: 6 months after enrollment for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: Measured at enrollment for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 3 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 1 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 3 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 2 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 3 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 3 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 3 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 4 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 5 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 6 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 7 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 8 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Low Risk | 2 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Medium Risk | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | High Risk | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Low Risk | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Medium Risk | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | High Risk | 0 Participants |
Other Pre-specified
Ask Suicide Screening Questions (ASQ)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide.
Time frame: week 9 for patients age 16 or younger
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Ask Suicide Screening Questions (ASQ) | Negative Screen | 2 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 1 Participants |
| Intervention | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Negative Screen | 1 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Non-Acute Positive Screen | 0 Participants |
| Control | Ask Suicide Screening Questions (ASQ) | Acute Positive Screen | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: Measured at enrollment for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 1 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 2 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 3 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 2 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 4 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 5 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 1 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 6 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 1 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Intervention | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Low Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | Medium Risk | 0 Participants |
| Control | Columbia Suicide Severity Rating Scale (CSSRS) | High Risk | 0 Participants |
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 7 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 8 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: week 9 for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.
Other Pre-specified
Columbia Suicide Severity Rating Scale (CSSRS)
Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).
Time frame: 6 months after enrollment for patients age 17 or older
Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.