Trial Outcomes & Findings for Intervention to Change Attributions That Are Negative (ICAN) (NCT NCT03648476)
NCT ID: NCT03648476
Last Updated: 2022-05-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Change from Baseline at Week 8 and Week 15
Results posted on
2022-05-23
Participant Flow
28 participants were enrolled (signed consent); however, 4 participants withdrew from the study PRIOR to randomization to the study arm.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
14
|
|
Overall Study
COMPLETED
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Intervention to Change Attributions That Are Negative (ICAN)
Baseline characteristics by cohort
| Measure |
ICAN
n=10 Participants
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.
|
WLC: Waitlist Control
n=14 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 10.7 • n=113 Participants
|
43.1 years
STANDARD_DEVIATION 12.7 • n=163 Participants
|
42 years
STANDARD_DEVIATION 11.7 • n=160 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=113 Participants
|
10 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
23 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
20 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=113 Participants
|
14 Participants
n=163 Participants
|
24 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline at Week 8 and Week 15Population: 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.
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.
Outcome measures
| Measure |
ICAN
n=8 Participants
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.
|
WLC: Waitlist Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Buss-Perry Aggression Questionnaire Score
Change from Baseline to Week 8
|
-1.7 score on a scale
Standard Deviation .27
|
-5.91 score on a scale
Standard Deviation 3.6
|
|
Change in Buss-Perry Aggression Questionnaire Score
Change from baseline to week 15
|
—
|
-8.51 score on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: Change from Week 1 at Week 8 and Week 15Population: Week 8 is post intervention for ICAN, but WLC will not have received the intervention.
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.
Outcome measures
| Measure |
ICAN
n=8 Participants
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.
|
WLC: Waitlist Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Anger Affect Score
Change from Baseline to Week 8
|
-1.95 score on a scale
Standard Deviation .19
|
-.89 score on a scale
Standard Deviation 2.17
|
|
Change in Anger Affect Score
Change from Baseline to Week 15
|
—
|
-4.49 score on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after receiving treatment)Population: 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.
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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference
Outcome measures
| Measure |
ICAN
n=7 Participants
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.
|
WLC: Waitlist Control
n=13 Participants
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.
|
|---|---|---|
|
Global Impression of Change for Anger and Aggression
|
4 score on a scale
Standard Deviation 1.90
|
4 score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: Week 8 for participants randomized to ICAN or Week 15 for those randomized to WLC (administered after received treatment)Population: 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.
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. 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference
Outcome measures
| Measure |
ICAN
n=7 Participants
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.
|
WLC: Waitlist Control
n=5 Participants
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.
|
|---|---|---|
|
Global Impression of Change for Perspective Taking and Empathy
|
5 score on a scale
Standard Deviation 1.15
|
6 score on a scale
Standard Deviation .55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline or Week 1 (depending on when collected) at Week 8 and Week 15We 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline at Week 8 and Week 15Participants 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline at Week 8 and Week 15The 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Week 1 at Week 8 and Week 15The 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline or Week 1(depending on when collected) at Week 8 and Week 15This 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).
Outcome measures
Outcome data not reported
Adverse Events
ICAN
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
WLC: Waitlist Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ICAN
n=24 participants at risk
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.
|
WLC: Waitlist Control
n=14 participants at risk
WLC participants do not receive treatment until after time two testing 8-weeks from time one testing.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
8.3%
2/24 • Number of events 2 • 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).
|
0.00%
0/14 • 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).
|
Other adverse events
| Measure |
ICAN
n=24 participants at risk
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.
|
WLC: Waitlist Control
n=14 participants at risk
WLC participants do not receive treatment until after time two testing 8-weeks from time one testing.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Musculoskeletal and connective tissue disorders
scapular dyskinesia
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Skin and subcutaneous tissue disorders
Skin Lupus episode
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Number of events 2 • 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).
|
0.00%
0/14 • 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).
|
|
Psychiatric disorders
Anger
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Infections and infestations
Cold
|
12.5%
3/24 • Number of events 3 • 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).
|
0.00%
0/14 • 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).
|
|
Infections and infestations
Flu
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Psychiatric disorders
Perseveration
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Gastrointestinal disorders
Bile Reflux
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Nervous system disorders
dizziness
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Social circumstances
Exhaustion
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
broken hand
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Infections and infestations
Allergies
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Muscle pain/ body aches
|
0.00%
0/24 • 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).
|
7.1%
1/14 • Number of events 3 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • 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).
|
0.00%
0/14 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place