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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD094232-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. This is a randomized waitlist control trial. The length of time in the trial is approximately 15 weeks and the intervention is 6 weeks long.
ICAN is the first treatment to target hostile attributions after TBI, making it a novel anger/ aggression management approach in this population. Since the investigator's prior research shows that stronger hostile attributions are associated with poorer perspective taking,39 ICAN employs a unique perspective-positioning technique to train perspective taking and reduce hostile attributions. After recalling a personal situation in which others' ambiguous actions led to an unpleasant outcome, participants will explore different perspectives: sitting or standing in one position, s/he will explore his or her own thoughts and feelings (self-perspective), then move to a different position to experience the other person's perspective, eliciting their thoughts and feelings.
In 40 participants with TBI, we will conduct a Phase I, randomized waitlist controlled trial with 4 data collection points: Baseline; Week 1; Week 8 (post-treatment for ICAN; post-wait period for WLC); Week 15 (WLC post-treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICAN | Experimental | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing |
|
| WLC: Waitlist Control | Other | WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICAN | Behavioral | A 6-week group therapy sessions once a week for 90-120 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Buss-Perry Aggression Questionnaire Score | The Buss-Perry Aggression Questionnaire (AQ), is a standardized measure comprised of 34 statements to assess total aggression, as well as the following aggression subconstructs: anger, hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point Likert scale (1, 2, 3, 4, 5). Subscales are summed to compute a Total Aggression raw score and total Aggressions Scores were then converted to T scores (1-100) with a mean T-score =50 and Standard deviation=10 points. Higher T-scores= more aggression/ worse outcome, thus a lower number indicates improvement Here, we are reporting the CHANGE in the group's MEAN t-score (e.g. Mean Post-test T score of 62 MINUS Mean Pre-test t score of 58 = Mean CHANGE score of -4, which means less aggression post-treatment). Thus, we are NOT reporting t-scores in this Results section; just the mean change of these scores. Negative scores indicate an improvement. | Change from Baseline at Week 8 and Week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anger Affect Score | The Anger-Affect Scale, from the PROMIS Anger, is a 5 item subjective questionnaire that requires participants to indicate the frequency with which they have been bothered by anger symptoms in the past week using a 5 point Likert scale (1.2,3,4,5). Total Raw scores range from 5-25. Higher scores indicate more severe anger; lower scores indicate lower levels of anger. Thus, a negative change score indicates a reduction in anger. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score | We will use 2 subscales from the Interpersonal Reactivity Index: Perspective-taking and Empathic Concern. It is a standardized, subjective measure that uses a 5 point scale. There are 7 questions for each subscale. Scale (0,1,2,3,4). Scores are calculated each subscale Perspective scale scores range from 0-28 Empathic concern scores range from 0-28 Higher scores indicate more perspective taking and empathy |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Neumann, Phd | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rehabilitation Hospital of Indiana | Indianapolis | Indiana | 46254 | United States |
28 participants were enrolled (signed consent); however, 4 participants withdrew from the study PRIOR to randomization to the study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | ICAN | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
| FG001 | WLC: Waitlist Control | WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions. ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ICAN | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
| BG001 | WLC: Waitlist Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Buss-Perry Aggression Questionnaire Score | The Buss-Perry Aggression Questionnaire (AQ), is a standardized measure comprised of 34 statements to assess total aggression, as well as the following aggression subconstructs: anger, hostile thoughts, and physical and verbal aggression. Participants rate statements using a 5-point Likert scale (1, 2, 3, 4, 5). Subscales are summed to compute a Total Aggression raw score and total Aggressions Scores were then converted to T scores (1-100) with a mean T-score =50 and Standard deviation=10 points. Higher T-scores= more aggression/ worse outcome, thus a lower number indicates improvement Here, we are reporting the CHANGE in the group's MEAN t-score (e.g. Mean Post-test T score of 62 MINUS Mean Pre-test t score of 58 = Mean CHANGE score of -4, which means less aggression post-treatment). Thus, we are NOT reporting t-scores in this Results section; just the mean change of these scores. Negative scores indicate an improvement. | Week 8 is post-intervention for ICAN, where as WLC had not yet received the intervention. Only WLC subjects were tested at Week 15, and that is their post-test. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at Week 8 and Week 15 |
Adverse events (AE) and Serious Adverse events (SAE) were tracked from the time the participant consented to be in the study until their last data collection point (i.e., through study completion). For those randomized to ICAN, this was on average, 4.25 months (range: 2.5 months-8.25 months). For those randomized to WLC, this was on average 6.25 months (range 4.5 months-10.25 months)
ICAN: Because all subjects ultimately received the ICAN intervention (even those who were randomized to WLC), we report AEs and SAEs that occurred surrounding the time of the delivery of ICAN treatment (i.e. during or after treatment delivery) for all 24 enrolled participants.
WLC: We report AEs and SAEs for those randomized to the WLC arm that occurred prior to treatment delivery (n=14).
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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 | ICAN | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Subject fell and hit head. Went to hospital and had normal MRI results. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Neumann | Indiana University | 3173292188 | dmneuman@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2021 | Apr 19, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2020 | Apr 19, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| Change from Week 1 at Week 8 and Week 15 |
| Global Impression of Change for Anger and Aggression | The Global Impression of change for Anger and Aggression is a 1 item question that measures perceived change in anger and aggression Using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
| Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment) |
| Global Impression of Change for Perspective Taking and Empathy | The Global Impression of change for Perspective Taking and Empathy is a 1 item question that measures perceived change in Perspective Taking and Empathy using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
| Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment) |
| Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15 |
| Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score | Participants are presented with 21 hypothetical scenarios are 21. After each scenario, participants rate attributions of intent, hostility, and blame, as well as how angry they would be in response to the scenario using a 9-point Likert scale. Scores are calculated for attributions of intent; 2) attributions of hostility; 3) attributions of blame; 4) and anger responses. Rating Scale:1,2,3,4,5,6,7,8,9 Scores are calculated for each attribution (intent, hostility, blame) and anger response) Separate average scores are calculated for attributions of intent, hostility, blame and ange. Average scores for each range from 1-9. Higher scores indicate more negative attributions or anger. | Change from Baseline at Week 8 and Week 15 |
| Change in The Awareness of Social Inference Test (TASIT) Score | The Awareness of Social Inference Test (TASIT) is a performance-based measure that uses short one minute video vignettes to assess emotion recognition and social inferences. Participants' responses are scored as right or wrong. Each correct response earns 1 points. Below are the three subtests that comprise the TASIT. Correct responses are tallied as total scores. Part I: Emotion Perception. 28 items. Score ranges from 0-28. Higher score is better performance. Part 2: Social inference (minimal context- not much context available to make inference of sincere and sarcastic exchanges). 15 items. Scores range from 0-15. Higher score is better performance. Part 3: Social Inference (Enriched context - more context available to make inference of sarcasm and lies). 16 items. Scores range from 0-16. Higher score is better performance. | Change from Baseline at Week 8 and Week 15 |
| Change in Difficulty With Emotion Regulation Scale (DERS) Score | The Difficulty with Emotion Regulation Scale (DERS) is a 5-point Likert scale that participants use to rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Total scores indicate emotion dysregulation or problems with regulating emotions. There are 6 subscales. Subscale scores are summed to generate a total emotion dysregulation score. Likert scale (1, 2, 3, 4, 5). Total Raw scores range from 36-180. Higher scores indicate more emotion regulation problems (worse outcome) Subscales are summed to compute a Total Emotion dysregulation raw score. | Change from Week 1 at Week 8 and Week 15 |
| Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score | This questionnaire consists of 15 written vignettes describing actions/ situations that were intentional (5), am-biguous (5) and accidental (5). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by two independent raters; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended re-sponse). | Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15 |
WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions.
ICAN: A 6-week group therapy sessions once a week for 90-120 minutes.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | ICAN | 6-week group therapy intervention with clinical RA comprised of 6 90-120 minute sessions beginning after Time 1 testing ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
| OG001 | WLC: Waitlist Control | WLC participants will delay treatment until after time two testing 8-weeks from time one testing. Participants will then begin 6 90-120 minute therapy sessions. ICAN: A 6-week group therapy sessions once a week for 90-120 minutes. |
|
|
| Secondary | Change in Anger Affect Score | The Anger-Affect Scale, from the PROMIS Anger, is a 5 item subjective questionnaire that requires participants to indicate the frequency with which they have been bothered by anger symptoms in the past week using a 5 point Likert scale (1.2,3,4,5). Total Raw scores range from 5-25. Higher scores indicate more severe anger; lower scores indicate lower levels of anger. Thus, a negative change score indicates a reduction in anger. | Week 8 is post intervention for ICAN, but WLC will not have received the intervention. | Posted | Mean | Standard Deviation | score on a scale | Change from Week 1 at Week 8 and Week 15 |
|
|
|
| Secondary | Global Impression of Change for Anger and Aggression | The Global Impression of change for Anger and Aggression is a 1 item question that measures perceived change in anger and aggression Using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
| This assessment was sent to the participants electronically. There is missing data from one participant who was randomized to ICAN. All participants (ICAN and WLC) had received the intervention by the time this outcome assessment was administered. | Posted | Median | Standard Deviation | score on a scale | Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment) |
|
|
|
| Secondary | Global Impression of Change for Perspective Taking and Empathy | The Global Impression of change for Perspective Taking and Empathy is a 1 item question that measures perceived change in Perspective Taking and Empathy using a 7-point scale (1="no change" to "A great deal better, and a considerable improvement that has made all the difference"). Total Raw scores range from 1-7.Higher scores indicate greater change.
| This assessment was sent to the participants electronically. There is missing data from several participants who did not return their survey after multiple attempts (ICAN missing data=1; WLC missing data=8). All participants (ICAN and WLC) had received the intervention by the time this outcome assessment was administered. | Posted | Median | Standard Deviation | score on a scale | Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment) |
|
|
|
| Other Pre-specified | Change in Interpersonal Reactivity Index (IRI) - Perspective Taking and Empathic Concern Score | We will use 2 subscales from the Interpersonal Reactivity Index: Perspective-taking and Empathic Concern. It is a standardized, subjective measure that uses a 5 point scale. There are 7 questions for each subscale. Scale (0,1,2,3,4). Scores are calculated each subscale Perspective scale scores range from 0-28 Empathic concern scores range from 0-28 Higher scores indicate more perspective taking and empathy | Not Posted | Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15 | Participants |
| Other Pre-specified | Change in Attributions of Hostility, Intent, Blame, and Anger (Epps Hypothetical Scenarios) Score | Participants are presented with 21 hypothetical scenarios are 21. After each scenario, participants rate attributions of intent, hostility, and blame, as well as how angry they would be in response to the scenario using a 9-point Likert scale. Scores are calculated for attributions of intent; 2) attributions of hostility; 3) attributions of blame; 4) and anger responses. Rating Scale:1,2,3,4,5,6,7,8,9 Scores are calculated for each attribution (intent, hostility, blame) and anger response) Separate average scores are calculated for attributions of intent, hostility, blame and ange. Average scores for each range from 1-9. Higher scores indicate more negative attributions or anger. | Not Posted | Change from Baseline at Week 8 and Week 15 | Participants |
| Other Pre-specified | Change in The Awareness of Social Inference Test (TASIT) Score | The Awareness of Social Inference Test (TASIT) is a performance-based measure that uses short one minute video vignettes to assess emotion recognition and social inferences. Participants' responses are scored as right or wrong. Each correct response earns 1 points. Below are the three subtests that comprise the TASIT. Correct responses are tallied as total scores. Part I: Emotion Perception. 28 items. Score ranges from 0-28. Higher score is better performance. Part 2: Social inference (minimal context- not much context available to make inference of sincere and sarcastic exchanges). 15 items. Scores range from 0-15. Higher score is better performance. Part 3: Social Inference (Enriched context - more context available to make inference of sarcasm and lies). 16 items. Scores range from 0-16. Higher score is better performance. | Not Posted | Change from Baseline at Week 8 and Week 15 | Participants |
| Other Pre-specified | Change in Difficulty With Emotion Regulation Scale (DERS) Score | The Difficulty with Emotion Regulation Scale (DERS) is a 5-point Likert scale that participants use to rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Total scores indicate emotion dysregulation or problems with regulating emotions. There are 6 subscales. Subscale scores are summed to generate a total emotion dysregulation score. Likert scale (1, 2, 3, 4, 5). Total Raw scores range from 36-180. Higher scores indicate more emotion regulation problems (worse outcome) Subscales are summed to compute a Total Emotion dysregulation raw score. | Not Posted | Change from Week 1 at Week 8 and Week 15 | Participants |
| Other Pre-specified | Change in The Ambiguous Intentions Hostility Questionnaire (AIHQ) Score | This questionnaire consists of 15 written vignettes describing actions/ situations that were intentional (5), am-biguous (5) and accidental (5). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by two independent raters; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended re-sponse). | Not Posted | Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15 | Participants |
| 0 |
| 24 |
| 2 |
| 24 |
| 12 |
| 24 |
| EG001 | WLC: Waitlist Control | WLC participants do not receive treatment until after time two testing 8-weeks from time one testing. | 0 | 14 | 0 | 14 | 7 | 14 |
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| scapular dyskinesia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Skin Lupus episode | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment | Both deemed unrelated to study |
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| Anger | Psychiatric disorders | Non-systematic Assessment |
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| Cold | Infections and infestations | Non-systematic Assessment |
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| Flu | Infections and infestations | Non-systematic Assessment |
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| Perseveration | Psychiatric disorders | Non-systematic Assessment | Perseveration was probably triggered by study questions. |
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| Bile Reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| dizziness | Nervous system disorders | Non-systematic Assessment |
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| Exhaustion | Social circumstances | Non-systematic Assessment |
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| Sinus Infection | Infections and infestations | Non-systematic Assessment |
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| broken hand | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Allergies | Infections and infestations | Non-systematic Assessment |
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| Muscle pain/ body aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| Change from Baseline to Week 15 |
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