Anxiety, Depression
Conditions
Keywords
Mental health, App, Mobile phone, Stress management
Brief summary
This study is an 8-week usability and feasibility trial of the smartphone student stress-management app IntelliCare for college students. This intervention will be tested with University of Illinois at Chicago (UIC) and Northern Illinois University (NIU) students. During this period, research surveys assessing depression and anxiety can be completed on the app. Also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of IntelliCare for College Students.
Detailed description
In this study, students will be recruited for an 8-week trial in which they will be given the IntelliCare Hub app and encouraged to use it daily. To ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores \> 10 on either the PHQ-9 or GAD-7 and 5 without elevated scores on either measure, for a total of 20 participants. The rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants. This trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use. During the trial, participants will be prompted to complete the PHQ-8 and GAD-7 every week. At baseline, 4 weeks, and 8 weeks, participants will be prompted within the app to complete the Depression Literacy Questionnaire and Anxiety Literacy Questionnaire to measure mental health literacy, the Knowledge and Beliefs about Services scale to measure knowledge of campus mental health services, the Barriers to Mental Health Help-Seeking questionnaire to measure treatment barriers, and the Cognitive and Behavioral Response to Stress Scale to measure cognitive and behavioral coping skills. At 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone. This is to gain insight on the user's experience with the app.
Interventions
BEHAVIORALMobile 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
Sponsors
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Mobile self-help intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participant is a student at the University of Illinois in Chicago or Northern Illinois University. Participant owns a smartphone capable of running Android 7 (or higher) or iOS11 (or higher). Participant is 18 years of age or older
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Literacy Questionnaire | Week 4 | 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. |
| Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | 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. |
| GAD-7 (Generalized Anxiety Disorder Scale-7) | 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. |
| The Cognitive and Behavioral Response to Stress Scale | Week 8 | 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. |
| Depression Literacy Questionnaire | 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 |
| Cognitive and Behavioral Response to Stress Scale | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Mean Number of Treatment App Use Sessions | Daily for two months |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Extended Usability of a Mobile Self-help Intervention |
|---|---|
| Age, Continuous | 24.19 years STANDARD_DEVIATION 6.03 |
| Anxiety Literacy Questionnaire | 13.88 units on a scale STANDARD_DEVIATION 3.67 |
| Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral frequency | 14.42 units on a scale STANDARD_DEVIATION 4.98 |
| Cognitive and Behavioral Response to Stress Scale CB-RSS behavioral usefulness | 17.74 units on a scale STANDARD_DEVIATION 6.1 |
| Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive frequency | 10.47 units on a scale STANDARD_DEVIATION 4.03 |
| Cognitive and Behavioral Response to Stress Scale CB-RSS cognitive usefulness | 9.73 units on a scale STANDARD_DEVIATION 6.23 |
| Depression Literacy Questionnaire | 13.89 units on a scale STANDARD_DEVIATION 4.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| GAD-7 (Generalized Anxiety Disorder Scale-7) Higher symptom | 10.82 units on a scale STANDARD_DEVIATION 4.12 |
| GAD-7 (Generalized Anxiety Disorder Scale-7) Lower symptom | 4.88 units on a scale STANDARD_DEVIATION 2.85 |
| Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module Higher symptom | 11.63 units on a scale STANDARD_DEVIATION 6 |
| Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module Lower symptom | 3.75 units on a scale STANDARD_DEVIATION 2.38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Anxiety Literacy Questionnaire
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Anxiety Literacy Questionnaire | 14.63 score on a scale | Standard Deviation 3.45 |
Primary
Anxiety Literacy Questionnaire
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Anxiety Literacy Questionnaire | 14 score on a scale | Standard Deviation 3.32 |
Primary
Cognitive and Behavioral Response to Stress Scale
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.
Time frame: Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Symptom | Cognitive and Behavioral Response to Stress Scale | CB-RSS behavioral usefulness | 19.22 score on a scale | Standard Deviation 7.38 |
| Lower Symptom | Cognitive and Behavioral Response to Stress Scale | CB-RSS cognitive usefulness | 12.22 score on a scale | Standard Deviation 6.53 |
| Lower Symptom | Cognitive and Behavioral Response to Stress Scale | CB-RSS cognitive frequency | 11.55 score on a scale | Standard Deviation 5.03 |
| Lower Symptom | Cognitive and Behavioral Response to Stress Scale | CB-RSS behavioral frequency | 15.72 score on a scale | Standard Deviation 7.2 |
Primary
Depression Literacy Questionnaire
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
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Depression Literacy Questionnaire | 14.5 score on a scale | Standard Deviation 3.97 |
Primary
Depression Literacy Questionnaire
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
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Depression Literacy Questionnaire | 14.68 score on a scale | Standard Deviation 3.83 |
Primary
GAD-7 (Generalized Anxiety Disorder Scale-7)
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | GAD-7 (Generalized Anxiety Disorder Scale-7) | 2.86 score on a scale | Standard Deviation 2.61 |
| Higher Symptom | GAD-7 (Generalized Anxiety Disorder Scale-7) | 10 score on a scale | Standard Deviation 3.83 |
Primary
GAD-7 (Generalized Anxiety Disorder Scale-7)
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | GAD-7 (Generalized Anxiety Disorder Scale-7) | 2.86 score on a scale | Standard Deviation 2.61 |
| Higher Symptom | GAD-7 (Generalized Anxiety Disorder Scale-7) | 10.14 score on a scale | Standard Deviation 2.79 |
Primary
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | 2.43 score on a scale | Standard Deviation 2.51 |
| Higher Symptom | Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | 9.28 score on a scale | Standard Deviation 2.49 |
Primary
Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module
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.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | 0.6 score on a scale | Standard Deviation 2.51 |
| Higher Symptom | Patient Health Questionnaire - 8 (PHQ-8) - Depression Severity Module | 9 score on a scale | Standard Deviation 6.53 |
Primary
The Cognitive and Behavioral Response to Stress Scale
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.
Time frame: Week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lower Symptom | The Cognitive and Behavioral Response to Stress Scale | CB-RSS cognitive frequency | 12.68 score on a scale | Standard Deviation 4.49 |
| Lower Symptom | The Cognitive and Behavioral Response to Stress Scale | CB-RSS cognitive usefulness | 12.58 score on a scale | Standard Deviation 6.86 |
| Lower Symptom | The Cognitive and Behavioral Response to Stress Scale | CB-RSS behavioral usefulness | 19.68 score on a scale | Standard Deviation 8.91 |
| Lower Symptom | The Cognitive and Behavioral Response to Stress Scale | CB-RSS behavioral frequency | 16.52 score on a scale | Standard Deviation 6.44 |
Secondary
Mean Number of Treatment App Use Sessions
Time frame: Daily for two months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Symptom | Mean Number of Treatment App Use Sessions | 17.05 days | Standard Deviation 8.12 |