Trial Outcomes & Findings for IntelliCare in College Students - Implementation (ICCS-I) (NCT NCT04108429)
NCT ID: NCT04108429
Last Updated: 2022-03-31
Results Overview
The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe
COMPLETED
NA
117 participants
Weekly symptom reports at Weeks 1, 2, 4, 6 and 8
2022-03-31
Participant Flow
Participant milestones
| Measure |
Mobile Self-help Intervention
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
|---|---|
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Overall Study
STARTED
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117
|
|
Overall Study
COMPLETED
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117
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline PHQ and GAD data were collected within the app, and many participants did not complete the measures
Baseline characteristics by cohort
| Measure |
Mobile Self-help Intervention
n=117 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
|---|---|
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Age, Continuous
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24.27 years
STANDARD_DEVIATION 5.93 • n=117 Participants
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Sex/Gender, Customized
Female
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96 Participants
n=117 Participants
|
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Sex/Gender, Customized
Male
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17 Participants
n=117 Participants
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Sex/Gender, Customized
Other
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2 Participants
n=117 Participants
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|
Sex/Gender, Customized
Declined to respond
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2 Participants
n=117 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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24 Participants
n=117 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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92 Participants
n=117 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=117 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=117 Participants
|
|
Race (NIH/OMB)
Asian
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25 Participants
n=117 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=117 Participants
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|
Race (NIH/OMB)
Black or African American
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12 Participants
n=117 Participants
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Race (NIH/OMB)
White
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56 Participants
n=117 Participants
|
|
Race (NIH/OMB)
More than one race
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15 Participants
n=117 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=117 Participants
|
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Region of Enrollment
United States
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117 participants
n=117 Participants
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Patient Health Questionnaire 8 (PHQ-8) depression score
|
10.5 units on a scale
n=73 Participants • Baseline PHQ and GAD data were collected within the app, and many participants did not complete the measures
|
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Generalized Anxiety Disorder - 7-item questionnaire (GAD-7) score
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10 units on a scale
n=73 Participants • Baseline PHQ and GAD data were collected within the app, and many participants did not complete these measures
|
PRIMARY outcome
Timeframe: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe
Outcome measures
| Measure |
Mobile Self-help Intervention
n=73 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
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|---|---|---|
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Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 8
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9.1 units on a scale
Standard Deviation 15.4
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—
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Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 1
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11.2 units on a scale
Standard Deviation 15.5
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—
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Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 2
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9.5 units on a scale
Standard Deviation 15.4
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—
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Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 4
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10.9 units on a scale
Standard Deviation 17.5
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—
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Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module
Week 6
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9.4 units on a scale
Standard Deviation 17.7
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—
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PRIMARY outcome
Timeframe: Weekly symptom reports at Weeks 1, 2, 4, 6 and 8The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.
Outcome measures
| Measure |
Mobile Self-help Intervention
n=73 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
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|---|---|---|
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Week 1
|
10.0 units on a scale
Standard Deviation 7.7
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—
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Week 2
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8.6 units on a scale
Standard Deviation 10.6
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—
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Week 4
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9.0 units on a scale
Standard Deviation 6.9
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—
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Week 6
|
9.4 units on a scale
Standard Deviation 14.2
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—
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Generalized Anxiety Disorder Scale - 7 (GAD-7)
Week 8
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10.3 units on a scale
Standard Deviation 10.9
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—
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PRIMARY outcome
Timeframe: Biweekly session utilization from August 1, 2018 (start of pre-implementation data collection; prior to the implementation trial) to December 18, 2020 (end of implementation period)Population: Data were collected from the counseling centers at both universities regarding how many appointments were scheduled each month from August 2018 to December 2020. For University A, August 2018 to January 2020 was labeled as the pre-implementation phase, and February 2020 to December 2020 was labeled as the implementation phase. For University B, August 2018 to July 2020 was labeled as the pre-implementation phase and August 2020 to December 2020 was labeled as the implementation phase.
Counseling session utilization data were examined on a biweekly basis to determine if the introduction of the IntelliCare for College Students program impacts counseling center utilization. Counts of types of sessions (e.g. intake appointments, individual counseling appointments, crisis appointments) attended by students were examined over time to look at potential changes. These data were collected from the university in aggregate, thus, there are not participant-level data.
Outcome measures
| Measure |
Mobile Self-help Intervention
n=6580 Appointments
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
n=18620 Appointments
Counseling Center Utilization at University B
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|---|---|---|
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Crisis - implementation
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1.7 Appointments
Standard Deviation 2.1
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7 Appointments
Standard Deviation 4.2
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Intake - pre-implementation
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25.4 Appointments
Standard Deviation 18.2
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117.1 Appointments
Standard Deviation 60.7
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Intake - implementation
|
9.7 Appointments
Standard Deviation 13.1
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99.8 Appointments
Standard Deviation 37.4
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Individual therapy - pre-implementation
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224.6 Appointments
Standard Deviation 138.3
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531.5 Appointments
Standard Deviation 166.2
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Individual therapy - implementation
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149.3 Appointments
Standard Deviation 85.1
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442 Appointments
Standard Deviation 122.6
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Counseling Center Utilization Data (e.g. Counts of Individual Counseling Appointments)
Crisis - pre-implementation
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3.3 Appointments
Standard Deviation 2.9
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12.8 Appointments
Standard Deviation 10.1
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PRIMARY outcome
Timeframe: Days of app use through study completion, up to 10 monthsThe mean number of days the app was used was drawn from the study app over the course of the study
Outcome measures
| Measure |
Mobile Self-help Intervention
n=117 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
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|---|---|---|
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Average Number of Days of App Usage
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6.29 days
Standard Deviation 11
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—
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SECONDARY outcome
Timeframe: Monthly questionnaire scores at baseline, one month and two monthsPopulation: There was a substantial amount of missing data on this scale
This is a measure of mental health literacy, specifically about symptoms of anxiety. Participants respond "True" or "False" to statements about anxiety and the correct responses are tallied to create total score. The range of score is range of scores is 0-22 with higher scores indicating greater literacy.
Outcome measures
| Measure |
Mobile Self-help Intervention
n=64 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
|
|---|---|---|
|
Anxiety Literacy Questionnaire
Baseline
|
14.4 units on a scale
Standard Deviation 3.3
|
—
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Anxiety Literacy Questionnaire
1 month
|
15.6 units on a scale
Standard Deviation 4.2
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—
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Anxiety Literacy Questionnaire
2 month
|
14.1 units on a scale
Standard Deviation 5.5
|
—
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SECONDARY outcome
Timeframe: Monthly questionnaire scores at baseline, one month and two monthsPopulation: There was a substantial amount of missing data on this measure
This is a measure of mental health literacy, specifically about symptoms of depression. Participants respond "True" or "False" to statements about depression and the correct responses are tallied to create total score. The range of scores is 0-22 with higher scores indicating greater literacy.
Outcome measures
| Measure |
Mobile Self-help Intervention
n=42 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
|
|---|---|---|
|
Depression Literacy Questionnaire
Baseline
|
16.2 units on a scale
Standard Deviation 2.9
|
—
|
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Depression Literacy Questionnaire
1 month
|
17.0 units on a scale
Standard Deviation 3.5
|
—
|
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Depression Literacy Questionnaire
2 month
|
16.7 units on a scale
Standard Deviation 2.9
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—
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SECONDARY outcome
Timeframe: Monthly questionnaire scores at baseline, one month and two monthsPopulation: There was a substantial amount of missing data on this scale
The CB-RSS is a 9 item measure of the frequency and perceived helpfulness of cognitive and behavioral coping skills. There are 4 subscales representing "Cognitive frequency" "Cognitive helpfulness" "Behavioral frequency" and "Behavioral helpfulness." Participants respond to the frequency items on a scale of 0 = Never to 6 = Always and to the helpfulness items on a scale of 0 = Not at all helpful to 6 = Extremely helpful. The scores range from 0-24 on the Cognitive subscales and from 0-30 on the Behavioral subscales. Higher values represent a better outcome.
Outcome measures
| Measure |
Mobile Self-help Intervention
n=36 Participants
Participants will have open access to the IntelliCare system.
IntelliCare for College Students: Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
|
University B
Counseling Center Utilization at University B
|
|---|---|---|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Usefulness Baseline
|
14.9 score on a scale
Standard Deviation 6.8
|
—
|
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Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Frequency Baseline
|
9.9 score on a scale
Standard Deviation 5.1
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Frequency 1 month
|
11.2 score on a scale
Standard Deviation 6.4
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Frequency 2 month
|
8.02 score on a scale
Standard Deviation 5.8
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Usefulness Baseline
|
9.5 score on a scale
Standard Deviation 5.7
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Usefulness 1 month
|
9.7 score on a scale
Standard Deviation 6.8
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Cognitive Usefulness 2 month
|
7.3 score on a scale
Standard Deviation 8.7
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Frequency Baseline
|
11.6 score on a scale
Standard Deviation 4.9
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Frequency 1 month
|
11.0 score on a scale
Standard Deviation 8.4
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Frequency 2 month
|
8.5 score on a scale
Standard Deviation 5.4
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Usefulness 1 month
|
17.0 score on a scale
Standard Deviation 11.0
|
—
|
|
Cognitive and Behavioral Response to Stress Scale (CB-RSS)
CB-RSS Behavioral Usefulness 2 month
|
8.4 score on a scale
Standard Deviation 8.6
|
—
|
Adverse Events
Mobile Self-help Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place