Trial Outcomes & Findings for IntelliCare in College Students (NCT NCT04035577)

Last Updated: 2020-10-08

Results Overview

This questionnaire is designed to assess anxiety specific mental health literacy by presenting 22 true or false statements regarding anxiety (e.g., "Being easily fatigued may be a symptom of anxiety disorder.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater anxiety specific mental health literacy.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Week 4

Results posted on

2020-10-08

Participant Flow

One participant withdrew from the study after signing the consent form but before initiating any of the study activities, and we consented an additional participant in their place. A total of 21 participants consented.

Participant milestones

Participant milestones
Measure	Extended Usability of a Mobile Self-help Intervention Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Extended Usability of a Mobile Self-help Intervention Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Subgroup means are provided

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Usability of a Mobile Self-help Intervention n=21 Participants Participants will have open access to the Intellicare Hub app for 8-weeks and be surveyed at Baseline, 4-weeks, and 8-weeks Mobile self-help intervention: During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of 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
Age, Continuous	24.19 years STANDARD_DEVIATION 6.03 • n=21 Participants
Sex: Female, Male Female	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=21 Participants
Race (NIH/OMB) More than one race	6 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module Lower symptom	3.75 units on a scale STANDARD_DEVIATION 2.38 • n=9 Participants • Subgroup means are provided
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module Higher symptom	11.63 units on a scale STANDARD_DEVIATION 6 • n=11 Participants • Subgroup means are provided
GAD-7 (Generalized Anxiety Disorder Scale-7) Lower symptom	4.88 units on a scale STANDARD_DEVIATION 2.85 • n=9 Participants • Subgroup means presented
GAD-7 (Generalized Anxiety Disorder Scale-7) Higher symptom	10.82 units on a scale STANDARD_DEVIATION 4.12 • n=11 Participants • Subgroup means presented
Anxiety Literacy Questionnaire	13.88 units on a scale STANDARD_DEVIATION 3.67 • n=21 Participants
Depression Literacy Questionnaire	13.89 units on a scale STANDARD_DEVIATION 4.29 • n=21 Participants
Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive usefulness	9.73 units on a scale STANDARD_DEVIATION 6.23 • n=21 Participants
Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive frequency	10.47 units on a scale STANDARD_DEVIATION 4.03 • n=21 Participants
Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral usefulness	17.74 units on a scale STANDARD_DEVIATION 6.10 • n=21 Participants
Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral frequency	14.42 units on a scale STANDARD_DEVIATION 4.98 • n=21 Participants

PRIMARY outcome

Timeframe: Week 4

The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-8 is 0-24. 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 20-24 is severe.

Outcome measures

Outcome measures
Measure	Lower Symptom n=9 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom n=10 Participants Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module	2.43 score on a scale Standard Deviation 2.51	9.28 score on a scale Standard Deviation 2.49

PRIMARY outcome

Timeframe: Week 8

The PHQ-8 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-24. 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 20-24 is severe.

Outcome measures

Outcome measures
Measure	Lower Symptom n=9 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom n=10 Participants Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module	0.6 score on a scale Standard Deviation 2.51	9 score on a scale Standard Deviation 6.53

PRIMARY outcome

Timeframe: Week 4

The 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

Outcome measures
Measure	Lower Symptom n=9 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom n=10 Participants Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
GAD-7 (Generalized Anxiety Disorder Scale-7)	2.86 score on a scale Standard Deviation 2.61	10.14 score on a scale Standard Deviation 2.79

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Lower Symptom n=9 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom n=10 Participants Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
GAD-7 (Generalized Anxiety Disorder Scale-7)	2.86 score on a scale Standard Deviation 2.61	10 score on a scale Standard Deviation 3.83

PRIMARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Anxiety Literacy Questionnaire	14 score on a scale Standard Deviation 3.32	—

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Anxiety Literacy Questionnaire	14.63 score on a scale Standard Deviation 3.45	—

PRIMARY outcome

Timeframe: Week 4

This questionnaire is designed to assess depression specific mental health literacy by presenting 22 true or false statements regarding anxiety and depression (e.g., "Loss of confidence and poor self-esteem may be a symptom of depression.") Participants receive a score of 1 for each statement they correctly assign as either true or false. Scores for each questionnaire can range from 0-22, with higher scores indicating greater depression specific mental health literacy

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Depression Literacy Questionnaire	14.5 score on a scale Standard Deviation 3.97	—

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Depression Literacy Questionnaire	14.68 score on a scale Standard Deviation 3.83	—

PRIMARY outcome

Timeframe: Week 4

This is an 18-item scale designed to measure the use and helpfulness of various cognitive and behavioral skills. There are four subscales included: cognitive skill frequency, cognitive skill usefulness, behavioral skill frequency, and behavioral skill usefulness. For each cognitive or behavioral skill, participants rate how often they used the skill and how helpful it was (e.g. "During the past month, how often did you take a moment to notice things that made you feel good or grateful? How helpful was this in making you feel better?"). Scores for cognitive subscales range from 0-24, and scores from behavioral subscales can range from 0-30. Higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive usefulness	12.22 score on a scale Standard Deviation 6.53	—
Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive frequency	11.55 score on a scale Standard Deviation 5.03	—
Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral usefulness	19.22 score on a scale Standard Deviation 7.38	—
Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral frequency	15.72 score on a scale Standard Deviation 7.20	—

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
The Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive usefulness	12.58 score on a scale Standard Deviation 6.86	—
The Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive frequency	12.68 score on a scale Standard Deviation 4.49	—
The Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral usefulness	19.68 score on a scale Standard Deviation 8.91	—
The Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral frequency	16.52 score on a scale Standard Deviation 6.44	—

SECONDARY outcome

Timeframe: Daily for two months

Outcome measures

Outcome measures
Measure	Lower Symptom n=19 Participants Participants who had PHQ-9 and GAD-7 scores under 10 at baseline	Higher Symptom Participants who had a score of 10 or greater on the PHQ-9 of GAD-7 at baseline
Mean Number of Treatment App Use Sessions	17.05 days Standard Deviation 8.12	—

Adverse Events

Extended Usability of a Mobile Self-help Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emily Lattie

Northwestern University

Phone: 3125033741

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place