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| Name | Class |
|---|---|
| Children's Health | OTHER |
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The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).
The primary aims of the proposed research are to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for the treatment of adolescents presenting with symptoms of depression in specialty medical care settings (e.g.Hematology/Oncology, Weight Management, etc.) at Children's Health System of Texas (CHST).
These aims will be accomplished by evaluating:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SparkRx | Experimental | 5-week CBT-based mobile intervention for adolescents with depressive symptoms |
|
| Educational Control | Active Comparator | 5-week mobile control with education about depression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-based mobile intervention for depression | Device | SparkRx is a 5-week program divided into levels intended to be completed weekly. SparkRx is a behavioral activation program. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and participant symptom check (PSC) in the mobile app. Tasks in the mobile app progress in a linear fashion (i.e., each task must be completed to progress to the next task). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intervention: Eligibility | Percent of potential participants eligible to participate | Screening |
| Feasibility of intervention: Participant willingness | Percent of eligible participants willing to participate | Screening |
| Feasibility of intervention: Completion adherence | Adherence to program determined by percent of enrolled participants completing all modules within 5 weeks and by post-treatment | 5 weeks |
| Feasibility of intervention: Module adherence | Adherence to program determined by average number of modules completed | 5 weeks |
| Feasibility of intervention: Time adherence | Adherence to program determined by engagement with program (time spent in app) | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms | Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.
| 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related change in depressive symptoms | Difference in the change in PHQ-8 scores between the SparkRx and control arms. Score range of 0 to 24 with higher scores indicating worse outcome. | Change over 5 weeks |
| Treatment-related change in anxiety |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Germann, PhD. | Children's Health System of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Texas | Dallas | Texas | 75235 | United States |
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| Mobile control with education about depression | Device | The control mobile application will consist of 5 weeks of educational content about depression. Participants will be instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and PSC in the mobile app. |
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| Adverse events | Rates of adverse events and adverse advice effects | 11 weeks |
| Usability | Usability measured with the System Usability Scale (SUS), which consists of 10 items, each with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores meaning more usable. | 5 weeks |
| Engagement | Engagement measured with the User Engagement Scale - Short Form (UES-SF), which measures self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Scores range from 1-5, with higher scores indicating more engaging material. | 5 weeks |
Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome.
| Change over 5 weeks |
| Treatment-related change in global functioning | Measured using the Short Form-36 (SF-36), a set of generic, coherent, self-reported, and easily administered quality-of-life measures used to routinely monitor and assess the care outcomes of participants. 8 subscales with scores ranging from 0-100, higher being a more favorable health state. Physical functioning Role limitations due to physical health Role limitations due to emotional problems Energy/fatigue Emotional well-being Social functioning Pain General health | Change over 5 weeks |
| Caregiver proxy treatment-related change in depressive symptoms | Measured using caregiver proxy measures of the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome. | Change over 5 weeks |
| Caregiver proxy treatment-related change in global functioning | Measured using caregiver proxy measures of the SF-36. 8 subscales with scores ranging from 0-100, higher being a more favorable health state. | Change over 5 weeks |
| Treatment-related change in hope | Measured using the Hope Scale, a 12-item self-report measure, which assesses dispositional hope in adults. Each item rated from 1-8 (definitely false - definitely true). Scores range from 8-64, with higher being more hopeful. Subscales: agency and pathway. | Change over 5 weeks |
| Healthcare utilization | Descriptive understanding of healthcare utilization. Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that assesses participants' use of healthcare resources. | Change over 5 weeks |
| Caregiver burden | Descriptive understanding of caregiver burden, measured by the work absenteeism questionnaire, containing questions about caregiving responsibilities and related impacts on employment. Higher scores indicate more hours missed per week of work. | Change over 5 weeks |
| Treatment-related change in physical symptom severity | Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome. | Change over 5 weeks |
| Treatment-related perceptions of experience with SparkRx | Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience (UMUX)-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the Happiness Tracking Surveys (HaTs); an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback. | 5 weeks |
| Treatment expectations | Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Stanford Expectations of Treatment Scale (SETS), an instrument for measuring positive and negative treatment expectancies. There are two subscales, the positive and negative expectancy. Scores range from 1-7, with higher scores indicating greater positive and negative expectancy. Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome. | 5 weeks |
| Treatment expectations: Credibility/Expectancy | Identifying the relationship between treatment expectations and treatment outcomes. Expectations measured with the Credibility/Expectancy Questionnaire (CEQ), a questionnaire for measuring cognitively-based credibility and relatively more affectively-based expectancy of therapy outcomes. Scores range from 6-60, with higher scores indicating a greater expectation of treatment success. Outcomes measured with the PHQ-8. Score range of 0 to 24 with higher scores indicating worse outcome. | 5 weeks |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D000294 | Adolescent Behavior |
| D006402 | Hematologic Diseases |
| D009369 | Neoplasms |
| D001835 | Body Weight |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
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