Depression Clinical Trial
Official title:
Randomized Control Trial to Evaluate the Efficacy of a Digital Mental Health Intervention Embedded in Routine Care Compared to Treatment as Usual in Adolescents and Young Adults With Moderate Depressive Symptoms
Randomized Controlled Trial comparing a coach-enhanced digital cognitive behavioral intervention (d-CBI) (RxWell) + treatment as usual (TAU) versus TAU alone for moderate depression as determined by Patient Health Questionnaire (PHQ-9) threshold as part of routine pediatric care. The study will be completed in pediatric practices with embedded behavioral therapists across 3 institutions (Children's Hospital of Pittsburgh, Boston Children's Hospital, Rady Children's Hospital, San Diego).
Status | Recruiting |
Enrollment | 750 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 22 Years |
Eligibility | Inclusion Criteria: - Age 16-22 inclusive recruited from outpatient pediatric clinic visit. - Meeting positive screen criteria depression by PHQ-9 criteria (score greater than or equal to10). - English-speaking (participant) - Smart phone access Exclusion Criteria: - Extremely severe depression (PHQ-9 greater than 24; or active suicidal plan). - Current dangerousness (based on Treatment for Adolescents for Depression Study (TADS) study criteria, 2004). Hospitalized for dangerousness within 3 months; Suicide attempt requiring medical attention within 3 months. - Severe, current psychiatric disorders based on SCID V (Clinical Trials Version) for bipolar disorder, current substance misuse or dependence, thought disorder. Research coordinators who are trained to fidelity threshold will complete this measure with the patient. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Rady Children's Hospital - San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depression severity | Children's Depression Rating Scale-Revised (CDRS-R) will be administered by a blinded rater from baseline up to 12 weeks after baseline to evaluate the change in depression severity. The CDRS-R is a 17-item interview, which score can add up to between 17 and 113. A score of greater than or equal to 40 indicates depressive symptomatology, and a score of less than or equal to indicates remission. |
12 weeks | |
Secondary | Change in depression severity; evidence of passive suicidal ideation | Patient Health Questionnaire (PHQ-9) will be utilized to measure change in depression severity and evidence of passive suicidal ideation from baseline up to 12 weeks after baseline. The PHQ-9 is a 9 item questionnaire. Scores can range from 0-27. A score of 0-4 indicates no depressive symptoms; 5-9 indicates mild depressive symptoms; 10-19 indicates moderate depressive symptoms; 20-27 indicates severe depressive symptoms. |
12 weeks | |
Secondary | Change in anxiety severity | Generalized Anxiety Disorder (GAD7) will be utilized to measure change in anxiety severity from baseline up to 12 weeks after baseline. GAD-7 is a 7 item questionnaire. Scores range from 7-21. Total scores of 0-4 indicates no anxiety; 5-9 mild anxiety; 10-14 moderate anxiety; greater than or equal to 15 indicates severe anxiety. |
12 weeks | |
Secondary | Change in quality of life | Satisfaction with Life Scale (SWLS) will be utilized to measure change in quality of life from baseline up to 12 weeks after baseline. SWLS is a five item measure with a maximum score of 35. Higher score correlate with higher satisfaction of life. Scores 31-35 extremely satisfied. Scores less than 9 indicate extremely dissatisfied. |
12 weeks | |
Secondary | Change in general level of functioning | Children's Global Assessment Scale (CGAS) blinded clinician rater will be utilized to measure the level of general functioning from baseline up to 12 weeks after baseline. CGAS scores range from 1-100 with 100-91 associated with superior functioning and 31-40 with major impairment in functioning in several areas, and unable to function in one of those areas. |
12 weeks |
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